Pain Outcomes Comparing Yoga Versus Structured Exercise (POYSE) Trial
Phase: NA
Conditions: Fibromyalgia
Sponsor: VA Office of Research and Development

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PAIN OUTCOMES COMPARING YOGA VERSUS STRUCTURED EXERCISE 
NCT01797263 
MAY 15, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL 
 
A.   RESEARCH OBJECTIVES 
Fibromyalgia is a chronic pain disorder characterized by widespread pain, multiple tender points, 
abnormal pain processing, sleep disturbances, fatigue, and often psychological distress.1  Individuals 
are often afflicted with fibromyalgia symptoms for years. For those with severe symptoms, fibromyalgia 
can be extremely debilitating and interfere with basic daily activities. Although numerous treatments are 
available for the management of fibromyalgia and some have showed initial promise, no treatment has 
demonstrated convincing effectiveness.  Thus, management is difficult for clinicians.  
Fibromyalgia is common; affecting an estimated 10 million Americans--approximately 3%-5% of the 
general population.2 Perhaps because fibromyalgia affects more women than men, little is known about 
fibromyalgia in men or veterans. Eisen et al. found that fibromyalgia was diagnosed almost twice as 
frequently in Gulf War Veterans compared to non-Gulf War Veterans.3 The prevalence in Iraq and 
Afghanistan War Veterans has not yet been reported.  If the 2010 American College of Rheumatology 
(ACR) diagnostic criteria are applied,4 which do not require tender point examination, the prevalence of 
fibromyalgia in men rises significantly.5  Two reasons explain the projected increase in fibromyalgia 
prevalence among veterans.  First, the 2010 ACR diagnostic criteria for fibromyalgia have gained wider 
use and acceptance. Second, the number of women veterans is expected to comprise over 10% of the 
total veteran population by 2020.6  
Medications are often the first line of therapy for fibromyalgia, but are frequently associated with 
adverse effects and show modest treatment benefits in clinical trials and practice.7 Aerobic exercise 
programs have proven benefit, but adherence to exercise is difficult to maintain and can lead to 
exercise-induced pain and myalgias if performed incorrectly.  While the literature supports 
psychological treatments such as cognitive behavioral therapy (CBT) for reducing the overall symptoms 
of fibromyalgia, access to therapists with fibromyalgia expertise is limited. For relief, patients often turn 
to complementary and alternative medicine when traditional treatments are not effective.8 Yoga has 
shown initial promise for relief of fibromyalgia symptoms; presumably because yoga combines the 
benefits of exercise with relaxation and mindfulness practices. However, few yoga studies in 
fibromyalgia exist and those conducted have involved small sample sizes and yoga has not been 
compared to other treatments. With these challenges and limitations in mind, research to develop and 
compare different treatments for fibromyalgia, especially in veterans, is urgently needed.  
We believe other treatment options are needed when pharmacological management fails to relieve 
fibromyalgia symptoms for veterans. Our long-term research objective is to develop, test, and 
implement novel treatments that address barriers to effective fibromyalgia treatment and that can be 
practicably applied in VA care settings. The Pain Outcomes comparing Yoga versus Structured 
Exercise (POYSE) Trial is a 2-arm parallel group, randomized clinical trial. The POYSE trial will target 
306 veterans with fibromyalgia and will compare the effectiveness of a yoga-based intervention 
(YOGA) with that of a structured exercise program (SEP).  The trial will last 9-months and participants 
will undergo comprehensive outcome assessments at baseline, 1, 3, 6, and 9 months. 
Study Aims: 
1) To compare the interventions’ (YOGA vs. SEP) effects on overall fibromyalgia severity at 
1 month (early response), 3 months (immediate post-intervention) and at 6 and 9 months 
(sustained effects) 
2) To compare the interventions’ effects on specific fibromyalgia symptoms (pain, sleep, 
fatigue), functional impairment, and related outcomes (quality of life, depression, anxiety) 
3) To compare the cost-effectiveness of the interventions  
Our primary hypothesis is that the yoga intervention will be more effective than a structured exercise 
program in reducing overall fibromyalgia severity as measured by the Fibromyalgia Impact 

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Questionnaire-Revised (FIQR); a global measure of fibromyalgia symptoms.9 Our secondary 
hypotheses is that yoga will be more effective than a structured exercise program in improving 
secondary outcomes including functional impairment, pain intensity, sleep quality, fatigue, quality of life, 
depression, and anxiety.   
The trial is powered to detect a clinically significant between-group treatment effect. Based on our pilot 
work and studies from other research groups, we expect both treatment arms to significantly improve 
fibromyalgia outcomes at all outcome assessment time points (1, 3, 6, and 9 months) compared to 
baseline. In addition to determining whether there is differential clinical effectiveness between the two 
treatments, their relative cost-effectiveness will be determined. 
 
B.       BACKGROUND 
B1.   Fibromyalgia is common, costly, and associated with frequent health care use 
 
Fibromyalgia affects at least 3%-5% of the general population10 or approximately 10 million Americans.  
In clinical populations, the prevalence of fibromyalgia exceeds 15%.11 Women account for more than 
80% of affected individuals. The economic burden to society from fibromyalgia-related lost productivity 
and disability is substantial. Sixteen percent of individuals with fibromyalgia reported receiving Social 
Security disability payments compared to 2.2% of the non-retirement US adult population.12 Analysis of 
administrative claims data from a large, Fortune 100 company showed that the total annual cost for 
fibromyalgia claimants was $5,945 versus $2,486 for other beneficiaries.13 
Patients with fibromyalgia are frequent users of health care resources; comparable to those with 
diabetes mellitus and hypertension.14 On average, those with fibromyalgia have 10 outpatient medical 
visits per year.15  When “nontraditional treatments” are considered, this number increases to 
approximately one visit per month.15 The mean yearly per-patient cost in 1996 dollars was $2,274.15  
Almost 50% of hospitalizations are related to fibromyalgia symptoms. Compared with patients with 
other rheumatologic disorders, those with fibromyalgia are more likely to have lifetime surgical 
interventions, including back or neck surgery, appendectomies, carpal tunnel release, gynecologic and 
abdominal surgeries, and tonsillectomies.15 
B2. 
Fibromyalgia is associated with significant morbidity and possibly mortality 
In terms of quality of life, persons with fibromyalgia consistently score low in multiple domains of mental 
and physical functioning, similar to patients with chronic obstructive pulmonary disease (COPD) and 
diabetes.16-18 Compared to patients with multiple sclerosis or rheumatoid arthritis, patients with 
fibromyalgia report greater fatigue, pain, depression, and anxiety.19 In fact, 20%-40% of fibromyalgia 
patients have a comorbid depressive disorder.20-23  
Intriguing reports have suggested that chronic widespread pain and fibromyalgia are associated with 
increased mortality.  When compared to subjects without pain, persons with chronic widespread pain in 
the community had an increased mortality risk (mortality rate ratio 1.31; 95% CI, 1.05-2.19).24  In a 
cohort study from Denmark, Dreyer et al reported an excess mortality risk of 30% (standardized 
mortality ratio 1.3; 95% CI, 0.9-1.7) in those with fibromyalgia.25 Using population mortality rates to 
compare, Wolfe et al also found an excess mortality risk (standardized mortality ratio of 1.45 (95% CI, 
1.19-1.86)).26 It is hypothesized that unhealthy lifestyle behaviors, including lack of exercise, explains 
this association between fibromyalgia and increased mortality.27 
B3. 
Fibromyalgia studies of veterans is limited  
Epidemiologic studies28,29 have assessed fibromyalgia prevalence and other symptom-based conditions 
among Gulf War Veterans. Buskila et al.29 found 17% of Gulf War Veterans with soft tissue rheumatism 
also had concomitant fibromyalgia; representing a much higher prevalence than seen in previous 
studies of military populations. In the Iowa Persian Gulf Study, fibromyalgia symptoms were reported by 
18%-24% of Gulf War Veterans relative to 9%-13% of non-deployed personnel.28 Eisen et al3 found that 
a diagnosis of fibromyalgia was twice as prevalent in deployed vs. non-deployed Gulf War Veterans. 

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Another study examined health care utilization and found that Gulf War Veterans were at an increased 
risk of postwar hospitalization for fibromyalgia.30 The prevalence in Iraq and Afghanistan War Veterans 
has not yet been reported. Beyond these epidemiologic studies focused on Gulf War veterans with 
fibromyalgia, research in veteran populations is limited. A potential explanation for this paucity of 
research is the perception that fibromyalgia is relatively uncommon in men.  Although fibromyalgia in 
men is largely unexplored, one study of men with fibromyalgia found they had more severe symptoms, 
worse physical function, and lower quality of life31 than women with fibromyalgia.  In this context, 
studies that focus on relieving the suffering of veterans with fibromyalgia are imperative.    
B4.   Medications are the most common treatments for fibromyalgia, but have modest benefits 
Medications for fibromyalgia are largely targeted at its symptoms, especially depression, sleep 
disturbance and muscle pain. Tricyclic anti-depressants, selective serotonin reuptake inhibitors (SSRI), 
skeletal muscle relaxants, analgesics, dual reuptake inhibitors (SNRIs), anticonvulsants, and dopamine 
agonists have been used with some success.1 In 2007, the Federal Drug Administration approved 
Lyrica (pregabalin) as the first medication to treat fibromyalgia.  Cymbalta (duloxetine) was approved in 
2008; and Savella (milnacipran) was approved in 2009. 
Despite some success with currently used medications, only one-third of patients in most trials who 
receive the active drug achieve a clinically meaningful improvement in their symptoms.32-34 There is 
evidence that fibromyalgia medications provide short-term (i.e. 8 to 12 weeks) improvements in 
symptoms,32-36 but given the chronic nature of fibromyalgia, more studies are needed to determine 
whether improvements are maintained over months or years. Patients used a mean of 2.7 fibromyalgia-
related medications;15 demonstrating the numerous therapies tried and the challenging nature of 
fibromyalgia treatment. Qualitative research has found that patients with fibromyalgia perceive that they 
are given multiple treatments without any chance for a cure.37  
B5. 
 Psychological therapies are helpful, yet not always available or acceptable 
Psychological and behavioral interventions have proven efficacy for fibromyalgia.38-40 Cognitive-
behavior therapy (CBT) is the most evidence-based psychological alternative to traditional medical 
approaches to fibromyalgia management. The benefits of CBT likely stem from its ability to intervene in 
the complex interplay of pathophysiology, cognition, affect, and behavior that is thought to drive pain 
and suffering. While CBT has proven efficacy, it is not yet widely available in many care settings, even 
in the VA despite mental health integration initiatives. Barriers to implementation are largely 
administrative and systemic and include time constraints, lack of knowledge in cognitive and behavioral 
strategies, and limited availability of specialists to deliver behavioral treatments. Many mental health 
professionals lack experience in applying CBT to medical conditions41 in general and fibromyalgia 
specifically. Furthermore, CBT may not be acceptable to many patients who fear the stigma of contact 
with mental health clinicians. 
B6.  
Aerobic exercise is effective, but adherence and exercise-induced pain are challenges 
Two systematic reviews42,43 and one meta-analysis44 support the effectiveness of supervised aerobic 
exercise for fibromyalgia. Randomized controlled trials have demonstrated that supervised aerobic 
exercise consistently improved physical function, especially physical fitness, well-being, and reduced 
tender point pain.45-49 Rossy et al reported that a physically based treatment for fibromyalgia had an 
effect size of 0.7 (p<0.05) for physical function improvement and 0.4 (p<0.05) for associated 
symptoms.44 Almost all the published exercise trials involved ≥ 12 weeks of supervised exercise 
program provided by a physiotherapist (or exercise physiologist) with expertise in fibromyalgia.  At 
adequate intensity, various types of aerobic exercise (e.g. cycling, walking, jogging and pool aerobic 
exercises) have all been shown to reduce the symptoms of fibromyalgia.47-51   
Individuals who consistently exercise are most likely to experience benefits, both in symptoms and daily 
function. The major limiting factor to exercise programs is adherence. After the supervised phase of an 
exercise program, exercise adherence declines and fibromyalgia symptoms worsen. Commonly cited 

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reasons for non-adherence are: time limitations, family commitments, the impact of other comorbidities, 
increased stress and exercise-induced pain or myalgias.                                           
 
 
B7. 
Other treatments are needed when fibromyalgia symptoms are not relieved 
The lack of relief from existing treatments is frustrating to patients who may feel like they have 
exhausted all options in their fibromyalgia treatment. This is also frustrating for VA providers concerned 
about the limited efficacy of medications and lack of additional treatment options. Therefore, novel 
treatment approaches that have potential for application across multiple VA clinical settings are needed 
to supplement existing services for fibromyalgia care. Increasingly, patients are interested in 
complementary and alternative medicine (CAM) treatment options.8 This growing interest in CAM is 
likely multifactorial, involving concerns about limited efficacy of conventional medicine, adverse effects 
of medications, and avoidance-beliefs related to medications or mental health treatments.8 CAM 
treatment options typically have minimal physical and emotional risks, and may allow patients to take a 
more active role in managing their illness.8  
B8. 
Yoga holds promise for fibromyalgia as it combines exercises and mental techniques 
Yoga therapy is defined by the International Association of Yoga Therapists as “the process of 
empowering individuals to progress toward improved health and well-being through the application of 
the philosophy and practice of yoga”.52 Yoga therapy attempts to incorporate yoga principles into a 
health regimen addressing health-related issues ranging from physical, psychological, and emotional 
health.53 The various styles of yoga that people use for health purposes typically combine physical 
postures, breathing techniques, and meditation or relaxation. The therapeutic effect of yoga is 
presumed to be related to the combination of postures, breathing strategies, and relaxation/meditation 
techniques; the combination is believed to be more beneficial than simple exercise alone.54 Because of 
the active mind-body component, it is believed that yoga is more effective than traditional exercise.55-57  
B10. 
Yoga is effective for chronic musculoskeletal pain, especially chronic low back pain 
Williams et al58 conducted a trial to evaluate the effects of Iyengar yoga on chronic low-back pain 
outcomes. The intervention patients attended 90-minute lyengar yoga classes twice a week for 12- 
weeks.  Compared to the usual control arm, the yoga group had significantly greater reductions in 
functional disability, pain, and depression at weeks 12 and 24, and at 6-months.  There were no 
significant differences in pain medication use between the groups. Groessl et al. examined the benefits 
of 10 weeks of yoga for veterans with chronic low-back pain.59 Significant improvements were found for 
pain depression, energy/fatigue, and mental health. In a recent and relatively large trial (N = 228), 
Sherman and colleagues,60 compared 12 weekly classes of either viniyoga-style yoga (emphasizing 
postures, breathing exercises, and guided deep relaxation) or conventional stretching exercises, or a 
self-care book. At 12 weeks, participants in the yoga group had greater improvement of symptoms and 
function than those in the self-care group. At 26 weeks, the yoga group sustained greater improvement 
in function over the self-care group. However, yoga was not superior to stretching exercises.60 
B11. 
Pilot studies and a meta-analysis suggest that yoga may be effective for fibromyalgia 
Several pilot studies have shown that yoga reduces fibromyalgia pain61-63 and improves maladaptive 
pain beliefs such as catastrophizing.61 The most methodologically rigorous study of yoga in fibromyalgia 
was conducted by Carson et al.61 In this trial, 53 fibromyalgia patients were randomized to an 8-week 
yoga program (gentle poses, meditation, breathing exercises, yoga-based coping instructions, and 
group discussions) or to wait-list control. At post-treatment, patients assigned to the yoga program 
significantly improved on fibromyalgia symptoms and functioning, including pain, fatigue, and mood, 
and in pain catastrophizing, acceptance, and other coping strategies. In a literature review examining 
the health benefits of yoga vs. exercise, the authors concluded that yoga interventions appeared to be 
equal or superior to exercise in nearly every outcome measured except those involving physical fitness 
and called for future trials to examine the distinctions between yoga and exercise.61   
Carson et al conducted an 8-week yoga exercise pre- and post-intervention study on 58 fibromyalgia 
subjects.64 Seven of the 58 subjects agreed to undergo pressure pain threshold assessment pre- and 

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post-intervention. At the end of the study, subjects (n=7) reported significant improvements in the FIQ-
revised total score (-30.7%), pain intensity (-51.2%) and strength (+21.3%), as well as, a significant 
increase in the pressure pain threshold (+21.3%).64 This study suggests yoga’s effect on pain sensitivity 
and some of the underlying mechanisms of pain relief in fibromyalgia. 
In a recent meta-analysis of the efficacy and safety of meditative movement therapies (Qigong, 
Tai Chi, and Yoga), Langhorst et al.65 found that yoga led to significant improvements in pain, 
fatigue, depression and quality of life. In addition, these treatments are safe leading to minimal 
drop-out rates (3.1%) because of adverse events. The authors called for higher quality studies 
with larger samples and comparisons of these therapies with established treatments.65   
B12. 
 A trial comparing yoga vs. structured exercise for fibromyalgia is timely and needed 
While there is trial evidence supporting both yoga and structured exercise, these approaches have not 
been compared against each other. The current POYSE trial design is a significant step beyond 
previous fibromyalgia trials. We believe a head-to-head comparative effectiveness study design best 
answers the question of how to most effectively treat fibromyalgia, especially for veterans’ refractory to 
other treatments. In addition, patients frequently differ in their treatment preferences, and a trial to 
determine the clinical effectiveness and cost-effectiveness of two evidence-based treatment options for 
fibromyalgia has immense importance. This population of veterans is particularly challenging to VA 
providers and alternative treatments are critically needed.     
B13. 
Our prior pain research that informs this POYSE trial 
We have performed numerous clinical trials and preliminary studies that demonstrate our team’s 
experience and expertise in three relevant areas: 1) management of musculoskeletal pain in veterans; 
2) conduct of clinical and translational fibromyalgia studies; and 3) design and test of yoga- and 
exercise based interventions in patients with fibromyalgia and other medical conditions.  Cumulatively, 
this body of research (summarized below) informs the POYSE trial: 
Stepped Care for Affective Disorders and Musculoskeletal Pain--SCAMP trial: Our National Institute of 
Mental Health funded SCAMP trial tested antidepressants combined with a pain self-management 
program delivered by nurse care managers, showed the intervention group (n = 123) experienced large 
improvements in depression severity (effect size = 1.1) as compared to usual care patients (n = 127) 
and moderate improvements in pain severity (effect size = 0.5).66  
Evaluation of Stepped Care for chronic Pain--ESCAPE Trial: We are actively preparing manuscripts for 
the VA RR&D-funded ESCAPE trial. ESCAPE is comparing a combination of pain treatments, including 
algorithm-based analgesics, pain self-management skills, and cognitive behavioral training, versus 
usual care.  The stepped-care intervention is targeting OEF/OIF/OND veterans with musculoskeletal 
pain of the spine (low back, neck) and extremities (legs, knees, hips, and shoulders). Recruitment of 
the 242 subjects was completed in May 2011 and follow-up of patients in March 2012. The ESCAPE 
study is significant because it is the first trial testing a novel combination of chronic pain treatments in 
the newest cohort of returning veterans. Two baseline ESCAPE papers have been published so far.   
The Care Management for the Effective use of Opioids (CAMEO) trial was recently funded by VA 
HSR&D.  We have recruited 55 patients to date. CAMEO is a two arm randomized trial to compare the 
effectiveness of pharmacological vs. behavioral approaches for veterans with chronic low back pain 
who are currently receiving chronic opioid therapy.  
Chronic widespread pain among returning Gulf War Veterans: In our study of predictors of incident 
chronic widespread pain in 602 Gulf War Veterans, 19% developed chronic widespread pain at follow-
up. A positive family history of medically unexplained persistent symptoms [odds ratio (OR) = 4.8 (2.3, 
13.2)] was strongly associated with chronic widespread pain. At baseline, individuals reporting 
preexisting symptoms of bronchitis [OR=4.9 (1.9, 12.3)] and cognitive dysfunction [OR= 2.1 (1.1, 4.2)] 
were more likely to develop chronic widespread pain. Rather than combat-related exposure, the 
perception of stress during the Gulf War [OR=1.6 (1.1, 2.3)] correlated with chronic widespread pain.67 

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A Pilot Study of Exercise-based Motivational Interviewing for Patients with Fibromyalgia tested the 
feasibility and acceptability of a supervised exercise program coupled with telephone-delivered 
motivational interview counseling to promote exercise adherence.68  As assessed by the Fibromyalgia 
Impact Questionnaire, physical impairment and pain improved significantly at 12- and 30- weeks, as did 
the number of exercise minutes per week. The number of exercise minutes was significantly associated 
with reduced physical impairment (r=-0.57, p=0.01). 
A Randomized Controlled Trial of Exercise-based Motivational Interviewing for Fibromyalgia—For this 
NIAMS-funded trial, 216 patients with fibromyalgia were randomized to 6 motivational interviewing 
sessions (n =107) or an educational control arm consisting of 6 fibromyalgia self-management lessons 
(n = 109).69 The intervention arm was superior to the educational control in increasing the number of 
hours of physical activity and pain reduction immediately post-intervention and at 3-month follow-up. In 
addition, more intervention patients than controls improved in FIQ-physical impairment scores and 6-
minute walk test measurements (43.9 (SD=6.3) vs. 24.8 meters (6.3), p=0.03) at follow-up. 
Yoga interventions for caregivers: We tested an 8-week yoga program with informal (family or friends) 
caregivers.70 Caregivers were randomized to a yoga intervention (n=8) or control group (n=9). Those receiving the 
yoga intervention demonstrated significantly increased lower body strength with trends for improved coping, upper 
body strength, and aerobic endurance.70  
Yoga interventions for breast cancer survivors: We also studied an 8-week yoga intervention in 40 breast cancer 
survivors and found significant increases (compared to the attention control group) in: lower body flexibility; side 
flexibility; lower body strength; and hand grip strength in the yoga group. The yoga group also demonstrated 
improved pain relief, stress reduction, and increased confidence.71 
A Yoga intervention to reduce fear of falling: We completed a yoga study to manage fear of falling in 14 
older adults.72 Participants showed a decrease in fear of falling, an increase in static balance, and a 
large improvement in lower body flexibility. This was the first study to examine the effect of yoga on fear 
of falling and balance in older adults. Given the frequent complaint of falling among patients with 
fibromyalgia, yoga interventions may have the potential additional benefits of preventing falls.   
Yoga for veterans with stroke: We recently completed VA QUERI-funded pilot study of 8 weeks of yoga 
for veterans with chronic stroke.73 In this study, we developed a standard yoga-based rehabilitation 
protocol with postures and breathing exercises in sitting, standing, and supine positions. Programming 
included mindfulness meditation and the protocol was tailored to consider physical abilities and activity 
tolerance of participants. Individuals at least 6 months post-stroke (n=45) were randomized 3:1 to yoga 
or wait list control. In within-group analyses, individuals in the yoga arm had significant improvement 
between baseline and 8 weeks in: pain, balance; range of motion; gait speed; walking endurance; 
balance self-efficacy; activity and participation; quality of life; and stroke related disability.   
C1. 
SIGNIFICANCE AND RELEVANCE TO VHA PATIENT CARE MISSION  
Pain is a critical health problem among veterans. Chronic pain affects 40%-70% of veterans74 and is a leading 
cause of disability, with substantial impact on millions of veterans’ lives. Pain was the most frequently reported 
symptom in Persian Gulf War Veterans75 and is expected to be even more prevalent in the current cohort of 
veterans.76 The effect of chronic widespread pain and fibromyalgia is far reaching, affecting society in terms of 
economic costs and lost work productivity and on fibromyalgia patients, in symptom burden, decreased physical 
functioning and perhaps even increased mortality. 
The VA has pioneered innovative organizational efforts, such as “Pain as the 5th Vital Sign” initiative77 and the 
VHA National Pain Management Strategy in an effort to address pain among veterans. The VHA National Pain 
Management Strategy was initiated in 1998,78 and established pain management as a national priority. The 
overall objective of the national strategy is to develop a comprehensive, multicultural, integrated, system-wide 
approach to pain management that reduces pain and suffering for veterans experiencing acute and chronic pain 
associated with a wide range of conditions, including terminal illness. Central to this objective is to assure access 
to an interdisciplinary pain care across VA facilities. Comparing the effectiveness of different approaches to treat 
fibromyalgia is critical in meeting strategy objectives. Despite the rising prevalence and negative impact of 
fibromyalgia, few intervention studies have addressed this condition in veterans. It is in this context that the 
POYSE trial is proposed.   

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Given the modest effectiveness of current treatments and the burden fibromyalgia places on veterans 
and clinicians, our research proposal is significant in several regards. First, the POYSE trial directly 
addresses a high priority area for the VA and is well aligned with the VHA Pain Management Strategy 
and VHA Pain Management Directive 2009-053.  Second, because previous fibromyalgia studies have 
included more than 90% women, our trial will provide information vital to begin filling an evidence 
vacuum regarding comparative effectiveness of treatments for fibromyalgia, especially men with 
fibromyalgia. Third, POYSE will extend our current understanding of non-pharmacological treatments 
for fibromyalgia. Fourth, the economic evaluation will provide useful information to VA administrators 
and managers to inform clinical implementation decisions.     
D. 
RESEARCH DESIGN AND METHODS  
D1.  Conceptual Model for POYSE Trial    
The management of fibromyalgia is complex. As a result, specialists such as rehabilitation therapists, 
orthopedists, anesthesiologists, rheumatologists, and neurologists, are often consulted. This common 
practice of referring patients with fibromyalgia to specialists with a relatively narrow focus 
compromises the effort to address whole-person care that employs a biopsychosocial approach-- an 
approach that seems best suited for rehabilitation settings in the VA.  
The biopsychosocial model posits that the causes and 
outcomes of many illnesses involve the interaction of 
physical and physiological factors, psychological traits and 
states, and social-environmental factors. Effective pain 
management accounts for these factors. The 
biopsychosocial model (Figure 1) is the most widely 
accepted conceptual model in pain medicine.79  
Comprehensive  management based on the 
biopsychosocial model of pain generation and perception 
improves outcomes.80 Such management focuses on the 
interplay among biological, psychological, and social factors 
that underlie the interventions to be tested and the key 
outcome domains to be assessed in POYSE. 
Applied to POYSE, the yoga-based intervention and 
structured exercise program will not simply address the 
biological or physical experience of fibromyalgia. Rather, 
POYSE interventions will be individually tailored taking into account how psychological and social 
factors influence function, pain severity, sleep quality, quality of life, and psychological symptoms.        
D2. 
OVERALL DESIGN  
Our study sample will include 306 veterans with fibromyalgia. Patients from the five primary care clinics 
and rheumatology clinic at the Roudebush VA Medical Center (RVAMC) and three community based 
outpatient clinics (Terre Haute, Martinsville, and Bloomington CBOCs) will be recruited to participate. 
The Pain Outcomes comparing Yoga vs. Structured Exercise (POYSE) study will be a 2-arm, parallel 
group, randomized comparative effectiveness trial.  After eligibility determination and informed consent 
procedures, participants will be randomized to one of two study arms. The YOGA arm will involve a 
standardized 12-week, yoga-based intervention and will consist of three treatment components: 1) in-
person group yoga taught by a yoga therapist; 2) a relaxation audio recording for home-use; and 3) a 
DVD recording to reinforce concepts taught during in-person sessions. Patients randomized to the 
structured exercise program (SEP) arm will participate in a 12-week exercise program delivered in a 
group/class format and supervised by a fitness instructor. In addition, SEP patients will receive a DVD 
(for home use) demonstrating aerobic, strengthening, and stretching exercises for fibromyalgia, a one-
on-one consultation session with the fitness instructor, and supervised exercise sessions for 12 weeks. 
Figure 2 shows the POYSE trial design.       
Figure 1: Biopsychosocial Model 

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The intervention period will last for 3 months, after which time patients will be followed for an additional 
6 months (total of 9 months). Treatment response will be assessed at 1, 3, 6, and 9 months after the 
date of the first intervention session.  The primary end point will be at 3 months (immediate post-
intervention).  Early response will be assessed at 1 month.  Sustained response will be assessed at 6 
and 9 months post-randomization. POYSE will last 4 years including 3 months for start-up; 2.5 years for 
recruitment; 9 months for follow-up; and 6 months for data analysis and manuscripts.  
Figure 2: POYSE Trial Design 
 
D3.   STUDY SITES 
The RVAMC is an urban, university-affiliated, tertiary care center in Indianapolis which provides health 
care for more than 53,000 veterans. As Indiana's tertiary care facility, RVAMC receives referrals from 
VA facilities at Ft. Wayne and Marion, Indiana, and from nearby Danville, Illinois. The RVAMC provides 
acute inpatient medical, surgical, psychiatric, neurological, and rehabilitation care, as well as primary 
and specialty outpatient services. The clinics staff 75 primary care providers (faculty and resident 
physicians; advance practice nurses), caring for over 20,000 patients who make over 65,000 visits per 
year. The RVAMC is also the parent facility to three community based outpatient clinics—the 
Bloomington, Terre Haute, and Martinsville Outpatients Clinics. The Bloomington and Terre Haute 
CBOCs staff 4 primary care providers each and 1 provider is based at Martinsville.  Each site provides 
primary care, prescription and other services to approximately 9,500 veterans in the Bloomington, Terre 
Haute, and Martinsville, IN metropolitan areas (all sites approximately 1 hour drive from Indianapolis). 
D4.   RECRUITMENT 
To plan for recruitment and assess feasibility, we conducted a search of CPRS to determine the 
number of RVAMC veterans with a primary or secondary diagnosis of fibromyalgia (ICD-9 729.1). We 
identified 8,457 unique veterans. Based on our SCAMP and ESCAPE trials, we have found that > 50% 
who meet the initial feasibility criteria also meet our study eligibility requirements, which will give us a 
potential population of over 4,200 patients from which to recruit 306 participants. Given that we are 
using the 2010 American College of Rheumatology4 diagnostic criteria for fibromyalgia, which is less 
restrictive than the 1990 criteria (i.e. does not require 11 of 18 tender points on examination), we expect 
to achieve our recruitment goals and sample size without much difficulty. In fact, > 60% of the 242 
ESCAPE participants would meet the new 2010 ACR fibromyalgia criteria.     
We have successfully enrolled patients for several moderately sized trials at our medical center. For 
example, in the SCAMP trial we successfully recruited over 65% of participants contacted in the VA. In 
our CRAFT study, 100 (84%) of 119 eligible veterans who were approached were successfully enrolled. 
In our “Pain as the 5th Vital Sign” pilot study, 159 (77%) of 206 participants surveyed expressed a 
willingness to participate in a clinical trial to treat their pain if offered such an opportunity. Based on 
these prior successes, we anticipate no difficulty meeting our sample size requirements. In terms of 
Veterans 
With 
Fibromyalgia 
Yoga 
Intervention 
(n=153) 
Structured 
Exercise 
(n=153) 
Randomization 
Baseline 
1 
mo 
3  
mo 
6 
 mo 
9  
mo 
Outcome Assessments 

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retention, we assessed 87% (217/250) of SCAMP participants at 6 months and 82% of participants 
(205/250) at 12 months.66 In the ESCAPE trial, we have assessed 91% (219/242) of veterans at 3 
months and 91.7% at 9 months.  
Consistent with previous studies conducted at RVAMC, the study sample will include at least 15% 
minorities, thus reflecting the demographics of our medical center. In our SCAMP study, Blacks 
comprised 16% of the veteran sample and 13% in ESCAPE.  We do not plan to over-sample Blacks (or 
other minorities) or power sufficiently to explore racial differences in treatment response. The 
racial/ethnic composition of RVAMC and participating CBOCs makes exploring racial differences in 
treatment response impractical unless we employed special efforts to recruit minorities other than 
Blacks. In ESCAPE, we have recruited 12.5% women, but expect an even higher proportion of women 
to participate in POYSE given its focus on fibromyalgia.     
D5a.  Identifying and Enrolling Potential Participants 
Providers will be informed of POYSE study details and will be asked to provide signed approval so that 
our team may contact their potentially eligible patients for participation in the trial. The POYSE research 
team, not the providers, will determine eligibility by applying the inclusion/exclusion criteria to potential 
participants during an “eligibility interview.” In our previous trials, over 95% of physicians contacted 
agreed to allow us to approach their patients. Potential participants will primarily be identified by 
querying the VA’s electronic medical record system, CPRS (Computerized Patient Record System), to 
create a master list of veterans who meet the following criteria: 1) fibromyalgia diagnosis (ICD9 code 
729.1); 2) clinic visit in past 2 years; and 3) moderate pain severity (pain severity score ≥ 5 out of 10).  
This list of potential participants will be updated monthly during the enrollment period and a recruitment 
letter, signed by their provider, will be mailed to qualifying veterans to describe the study. Potential 
participants will be contacted by phone within a week after receipt of the letter to assess eligibility and 
determine their interest in participating. If the veteran is eligible, an appointment will be scheduled to 
obtain a signed informed consent statement, HIPAA authorization from and VA consent for use of 
picture and/or voice those who desire to participate. The baseline interview and assessments will be 
conducted by research assistants blinded to treatment allocation.  
This method of identifying potential study subjects through CPRS and contacting them for possible 
study participation has been approved by both our university IRB and VA Scientific Review Committee 
for the SCAMP (which enrolled 200 veterans) and ESCAPE trials (which enrolled 242 veterans). A 
second method, if needed, will be in-clinic contact of potential subjects by cross-referencing the CPRS 
list with the weekly appointment roster for each participating VA provider. A third method is self-referral 
by patients responding to study advertisement displayed in hospital elevators and primary care, 
rheumatology, and rehabilitation clinics.    
D5b. Eligibility   
Veterans will be eligible if they have: 1) 2010 American College of Rheumatology (ACR) diagnostic 
criteria (Table 1 below) for fibromyalgia;4 2) moderate pain severity (“current” pain severity score ≥ 5 
out of 10); 3) stable doses of fibromyalgia medications for at least 4 weeks; and 4) access to a working 
telephone. Exclusion criteria will include: 1) severe medical conditions in which exercise is 
contraindicated; 2) active psychosis; 3) schizophrenia; 4) active suicidal ideation; 5) moderate to severe 
cognitive impairment; and 6) involvement in ongoing yoga classes or moderately intense (brisk walking) 
exercise program in the previous 3 months..  Access to a telephone (home or mobile) is required 
because most of the outcome assessments will be conducted via phone.   
Exclusion criteria will be determined during the baseline eligibility survey conducted by our study team 
(not the patient’s providers) and are designed to eliminate potential participants for whom the proposed 
interventions are inappropriate or unsafe and/or for whom there may be disincentives for improvement. 
These include severe medical conditions that may limit participation: (1) significant cardiovascular 
disease: New York Heart Association functional class 3 or 4 congestive heart failure; systolic blood 
pressure ≥ 180 or diastolic blood pressure ≥ 105 mmHg; myocardial infarction, stroke, or transient 

11 
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ischemic attack (TIA) within 6 months; chest pain or dizziness with exercise; (2) COPD or asthma 
needing home oxygen; (3) cancer (other than skin cancer) receiving treatment or treatment planned in 
the next 6 months; (4) at least moderately severe cognitive impairment defined by a 6-item screener.81 
D6. 
RANDOMIZATION   
Stratified and blocked randomization will 
be performed.  After providing written-
informed consent and completing their 
baseline interview, participants will be 
randomized to one of two arms: 1) yoga-
based intervention (YOGA); or 2) a 
structured exercise program (SEP). The 
randomization process will be 
directed by Zhangsheng Yu, PhD 
(statistician) using statistical software 
with a random-number generator to 
create a list of group assignments 
before study recruitment begins. 
Randomization will be stratified by 
sex (men vs. women) and study 
recruitment site (VAMC vs. CBOC).  Within strata, randomization with block sizes of 4 or 6 will 
be executed to ensure balance. Once an eligible participant has been screened, has signed 
informed consent, and has completed the baseline measures the research assistant (Amanda 
Gerwig) or project coordinator (Christy Sargent) will submit a request to randomize the eligible 
participant. The randomization program locates the first unassigned record in the randomization 
list and assigns the participant to the group designated in that record. The participant identifier 
and date are written to the record. To ensure allocation concealment, only Ms. Sargent and Dr. 
Bair will have access to the randomization table, but will not conduct outcome assessments.  
Dr. Yu will remain blinded to group assignment. No one will be allowed access to the folder of 
the randomization assignment until all baseline measures have been completed. 
D7. 
POYSE INTERVENTION DETAILS 
The POYSE interventions will last 3 months. The length of follow-up and schedule of outcome 
assessments at 1, 3, 6, and 9 months after the date of the first intervention session are to detect three 
types of treatment effects: 1) “early response” (at 1 month); 2) immediate post-intervention benefits 
at 3 months; and 3) sustained benefits at 6 and 9 months post-randomization (3 and 6 months post-
intervention).  
D7a. 
Overview of Yoga-based intervention  
The yoga intervention (Appendix 1) will consist of three treatment components: 1) in-person group 
yoga sessions taught by a yoga therapist; 2) a relaxation audio recording for home-use; and 3) a DVD 
recording to reinforce concepts taught during in-person yoga sessions. The yoga intervention will 
complement standard medical treatments for fibromyalgia.  It will involve 12 weekly group sessions of 
8-12 patients per group. Each yoga session will last approximately 90 minutes and will be led by Nancy 
Schalk, Yoga Therapist (YT), who has over 30 years of experience in teaching yoga and meditation 
techniques to the general public and medical patients, including veterans. Ms. Schalk has trained in 
several schools of yoga, but draws most significantly from the Sivananda tradition. She has also 
received veteran-specific yoga training in a program called “Warriors at Ease.” Ms. Schalk will be the 
lead yoga therapist, but will train and supervise other yoga therapists to enhance future implementation.   
The yoga intervention is designed to improve functioning, pain, fatigue, sleep problems, and 
psychological distress common to patients with fibromyalgia. The intervention will include exercises or 
physical activity that includes postures (asanas), diaphragmatic breathing (pranayama), 
relaxation/meditation practices (dhyanas), and discussions sessions between Ms. Schalk and group 
Table 1. 2010 ACR Fibromyalgia Diagnostic Criteria 
A patient satisfies diagnostic criteria for fibromyalgia if the 
following 3 conditions are met: 
 
1. Widespread Pain Index (WPI) ≥ 7 and Symptom 
Severity Scale (SS) ≥ 5 OR WPI 3-6 and SS ≥ 9 
 
2. Symptoms have been present at a similar level for 
at least 3 months 
 
3. The patient does not have a disorder that would 
otherwise explain the pain 
 
For full criteria: See Wolfe et al. citation 4 
 

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participants to exchange “lessons learned.” Patients will be given yoga mats and eye pillows and will 
have access to yoga blankets, yoga straps, and bolsters for doing yoga poses.     
To standardize delivery and facilitate reproducibility of the yoga intervention, we detail the content and general 
structure of each class (Table 2) which will be followed by Ms. Schalk, YT. Procedures to assure fidelity to the 
yoga intervention will be used similar to those employed in our other trials. Briefly, steps will include:  (1) 
extensive yoga therapist training conducted by Ms. Schalk during start-up; (2) observation of Ms. Schalk 
administering yoga sessions for at least one full wave (12 sessions) feedback provided by Ms. Schalk after review 
of several sessions and periodic meetings to discuss fidelity.   
D7b. 
Yoga intervention site, schedule of sessions, and group size 
The in-person group yoga sessions will be held at the Rehabilitation and Integrative Therapy Lab (RIT 
Lab, in Coleman Hall on the Indiana University Purdue University Indianapolis campus, School of 
Health and Rehabilitation Sciences. The RIT lab is less than a 10 minute walk from the RVAMC. The 
12 weekly sessions will include 8 to 12 participants; a group size we found optimal during our pilot 
study.72  Based on our sample size calculation, we will conduct 15-19 groups (of 8-12participants) to 
complete the yoga intervention. Attendance will be recorded to assess adherence to yoga. 
D7c. 
Yoga intervention components, sequence, and progression 
The 12-week yoga intervention (Table 2) developed and previously tested by Drs. Schmid and Van 
Puymbroeck and Ms. Schalk72 will be modified for veterans with fibromyalgia. For example, Ms. Schalk 
will emphasize “gentle practice” of yoga exercise when veterans are challenged by fibromyalgia or 
other chronic illnesses. The yoga exercises will be delivered in a standardized sequence and 
progression, as delivered in our pilot study of veterans with stroke. The yoga poses or asanas will 
consist of a single sequence that can be performed supine, seated, on hands and knees, prone, and 
standing. Similar to other rehabilitation interventions, our yoga intervention will progressively become 
more challenging for participants over the 12 weeks. 
The standardized sequence of yoga poses will be introduced to participants. Appendix 2 outlines the 
full array of poses to be used. The poses will begin in the seated position and consist of five poses that 
involve “breathing with movement” (head moves, scapula, and directions of the spine, pinwheel and 
pendulum).  Additional poses will include: “table,” “cat cow,” “sunbird,” “downward dog,” “cobra,” 
“locust,” and “bridge.” Ms. Schalk will encourage the safe performance of physical poses and tailor 
them to participants’ needs and abilities. For patients with fibromyalgia, poses will avoid the extremes of 
range of motion. All sessions will end with a yoga nidra (“yogic sleep”) exercise to develop both deep 
relaxation and full alertness.  
Deep breathing exercises will be taught and emphasized throughout every session. “Connecting with 
the breath” is a common theme in yoga and is combined with the poses (“breathing with movement”) to 
facilitate yoga practice.  An effective breathing technique (alternate nostril breathing) will be taught to 
participants.  All yoga sessions will include at least 10 minutes of relaxation, using progressive 
relaxation techniques. The relaxation component will be completed lying supine and aided with an eye 
pillow and yoga mat for each participant. The relaxation is based on resting the “physical body.”  
Participants will be encouraged to exercise according to their limits, rather than rigid adherence to 
posture techniques. The yoga intervention will be tailored to the individual. It will include low intensity, 
low impact modified poses adapted with pathophysiologic changes of fibromyalgia in mind.82 For 
example, and repetitive muscle movements will be minimized to reduce the potential for muscle micro-
trauma theorized to occur in fibromyalgia patients.  In addition, Ms. Schalk will encourage slow 
transitions from lying to standing to minimize dizziness and lightheadedness related to autonomic 
nervous system changes associated with fibromyalgia.  Peripheral pain generators such as knee 
osteoarthritis, back pain, and carpal tunnel symptoms will be minimized by adapting standing poses to 
sitting or lying poses or using bolsters or pads. Previous studies that involved high intensity, repetitive 
exercises reported high rates of attrition or worsening fibromyalgia symptoms.62, 82, 83 Tailoring of poses 
in POYSE is expected to yield lower attrition rates. 

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A proposed detailed schedule of the 12 yoga sessions and each session’s content is found in Append 
 
D7d. 
Yoga intervention: relaxation audio recording 
From our pilot work, a relaxation audio recording was professionally developed and produced for 
participants. The recording features Ms. Schalk guiding a physical body relaxation exercise and is 
placed onto Playaway devices (www.playaway.com); an inexpensive (~$20) portable audio player. The 
Playaway device only holds the guided relaxation exercise and cannot be recorded over. It is easy to 
use, has simple directions, and works with minimal buttons, i.e. ‘power’ and ‘play’. All participants 
randomized to the yoga arm will be issued a Playaway device and will be asked to listen to it three 
times a week to reinforce in-person yoga session content. Because the device records and times 
whether or not the device is used, this feature will help assess adherence to the yoga 
intervention and home use. We will record the date and time in minutes that audio recording is used 
at each session.  Use of yoga will be tracked for the entire 9 month study period.  To minimize lost 
devices, they will be labeled with POYSE study name and contact information. 
D7e. 
Yoga intervention: DVD recording 
All participants in the yoga arm will receive a DVD and an illustrated handbook to complement the 
audio recording. Similar to our audio-recording, the DVD will be professionally developed and highlight 
Ms. Schalk moving from start to finish through the yoga intervention. These DVDs will be given to 
participants at the beginning of the intervention and help participants apply yoga practices to daily life 
during the intervention period. Participants will be encouraged to practice at home for 20 to 40 minutes 
daily, at least 3 days per week. For adherence monitoring, participants will track their use of the 
DVD and record time spent in yoga practice on a form (Appendix 5). These forms will be collected 
during the weekly sessions. To boost retention and adherence, POYSE study personnel will contact 
veterans’ who miss a session to problem-solve regarding attendance barriers and or to address home 
practice barriers (if average practice < 20 minutes per home session).  
D7f. 
Overview of structured exercise program group sessions  
The group exercise sessions will also be held at the RIT lab in Coleman Hall on campus. 
Participants will undergo a graded aerobic exercise program; the preferred exercise prescription to 
reduce the possibility of exercise-induced pain.48, 84-86 The exercise program will start at a low intensity, 
last for a short period of time, with gradual increases in exercise intensity and duration. Participants will 
start exercising at a slow pace for 5 minutes to warm-up.  For each 5-minute phase (total of 30 to 35 
minutes total per session), the exercise intensity will be gradually increased to the mid-range of their 
exercise prescription. 
During the first exercise session, the fitness instructor will provide an introduction and overview of the 
exercise program.  Veterans will also receive instructions on how to use the heart rate monitor, 
pedometer, and how to rate their perceived exercise exertion according to the Borg scale.  In addition, 
veterans will learn how to keep an activity diary at home and how to select physical activities and 
exercises based on heart rate, perceived exertion, or metabolic energy costs. Further, subjects will 
have their blood pressure and heart rate monitored during all sessions.  Subjects will be asked to report 
any cardiovascular symptoms such as shortness of breath or chest pain while exercising.  If a subject 
experiences any cardiovascular symptoms or an unsafe blood pressure or heart rate the instructor will 
cal an ambulance to transport the subject to the VA ER for immediate medical assessment. 
Exercise sessions with other participants and the fitness instructor will last approximately 75 minutes 
and occur once a week for 12 weeks; the same session schedule and duration as the yoga arm. The 
fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine 
baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide 
educational tips on exercise and selection of physical activities.  The instructions will be informed by 
veterans’ heart rate (at baseline and at different exercise levels), their ratings of perceived exertion, and 
metabolic activity (METS). While we will employ individualized exercise prescriptions for veterans 

14 
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Study #1211010073 
randomized to the structured exercise program (SEP) arm, the SEP will be delivered in a group/class 
format to control for the potential benefits of social interactions and attention across treatment arms.   
D7g. 
Exercise ergometer starting point, perceived exertion, and metabolic activity  
In general, participants will start exercising with the ergometer at a power of 30 watts for 5 minutes, 
followed by increases of 15 watts every 5 minutes until veterans reach their sub-maximum target heart 
rate [(220 − age) × 0.85].  After each 5-minute phase, heart rate, blood pressure, and a rating of 
perceived exertion will be recorded. To obtain ratings of perceived exertion, veterans will be evaluated 
according to the Borg Scale,87 which ranks exertion ordinally (“very, very light” to “very, very hard”). 
These terms are assigned a number from 7 to 20. If the target heart rate is not reached, the test will be 
stopped at a score of 17 (“very hard”). We want participants to exercise with the ergometer at a level 
associated with a perceived exertion of 12 on the Borg Scale, i.e. the level below “somewhat hard” for 
the prescribed duration while wearing a heart rate monitor. This level is consistent with light-to-
moderate exercise recommended in the fibromyalgia literature.48, 84-86 
Combining perceived exertion with the structured exercise program allows veterans to better gauge 
their “comfort zone” and select physical activities based on how they feel on any given day. Heart rate 
monitoring provides useful information for our fitness instructor and veterans to set their exercise 
intensity based on different levels of exercise. Energy output data from the sub-maximal test will be 
converted to equivalent energy costs in metabolic activity (METS).  The METS will then be 
benchmarked for a wide variety of recreational and occupational activities relevant to the veteran. 
D7h. 
Schedule and content of weekly exercise sessions  
In addition to the schedule of supervised group exercise sessions as shown in Appendix B, veterans 
will be asked to exercise independently a minimum of two or three times per week during the 12-week 
intervention period. To track the extent of home exercise and activities, we will ask participants to 
fill out and bring their tracking diary to each exercise session. The exercise intensity will be 
modified during sessions according to how the veteran reacts to exercise. The intensity and duration of 
each exercise session will be gradually increased as tolerated and as the veteran’s fitness level 
changes. At each weekly session, veterans will report the number of times and the total minutes 
exercised. The self-report of at home exercise activity will be confirmed with pedometer readings, i.e. 
step counts.  After the 12 sessions are completed, study personnel will conduct monthly calls at months 
4, 5, and 6 to check adherence, prevent inactivity, and track exercise activity during the follow-up 
period.   
After the first session, participants will receive a brief educational message each week from the fitness 
instructor. After soliciting what exercise activities veterans are willing to do, the fitness instructor will 
teach ways to incorporate physical activities in veterans’ daily life.  Participants will also learn their 
typical heart rate, rating of perceived energy, and metabolic energy cost associated with each activity 
and provide a record of their weekly activities using an activity diary and step count assessed from their 
pedometer. The importance of regular physical activity for improved health and adherence to the 
individualized exercise prescription will be emphasized at each session. For “homework”, veterans will 
be asked to choose a physical activity to do before the next session. Educational messages will be 
reinforced with a professionally produced exercise DVD to view at home. The exercise DVD will contain 
instructions to modify participants’ exercise in case of a flare of their fibromyalgia and to be progressive 
(chair work to standing) in terms of intensity and duration depending on their baseline exercise 
prescription. Attendance at the exercise group sessions will be recorded. 
D7i. 
Plans to manage exercise-induced pain and injury  
Strenuous exercise, especially if done too vigorously, can exacerbate fibromyalgia symptoms and 
adversely affect exercise adherence.88 Exercise-induced pain is postulated to be caused by an 
overload of local musculoskeletal structures, leading to micro-trauma or tendonitis89-91 or to “central 
sensitization” (amplification of sensory processing within the brain)92-95 resulting in an exacerbation of 
symptoms. Patients who suffer from exercise-induced pain often do not follow through with an exercise 

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Study #1211010073 
program; consequently, affecting adherence and clinical outcomes.  To improve adherence and clinical 
outcomes, exercise prescriptions should be individualized based on patient’s baseline severity of pain 
and fatigue, and tolerance to exercise-induced pain.82,88  
To minimize muscle micro-trauma and exercise-induced muscle soreness, we will employ the following 
safety precautions:  
1. Participants will be advised not to exceed the prescribed exercise (frequency, intensity, or 
duration) during a “good day.” 
2. Participants will be forewarned that even exercise performed at the appropriate 
intensity might result in short-term increases in exercise-induced pain and fatigue that should 
dissipate within a few days (up to 2 weeks). 
3. Participants will be allowed to self-adjust their exercise intensity, especially during a flare. 
4. Participants who develop intolerable exercise-induced pain (or fatigue) will be instructed to avoid 
exercise for 48 hours, then restart the program at 5% below the previous exercise intensity (e.g., 
from 55% to 50%) for one week, and maintain the same exercise duration for one week, thereafter.  
Then resume the previous exercise intensity (e.g. 50% back up to 55%), and continue on with the 
original exercise prescription.     
5. Should a participant develop an increase in regional body pain (e.g., foot or ankle pain) as a result 
of the aerobic exercise, they will be asked to do the following:  
a. RICE: Rest, Ice, Compression of injured tissue, and Elevation during the first 24 hours,  
b. Switch to a different type of exercise (e.g., from brisk walking to bicycling or from weight 
bearing to non-weight bearing exercise).   
6. In the event that participants are unable to exercise for > 2 weeks, they will be instructed to resume 
their exercise at 65% of their previous exercise duration (in minutes) and 5% below the previous 
exercise intensity. If they fail to exercise for < 2 weeks, they will restart at the level (i.e. duration and 
intensity) from where they left. Then, they will follow the original recommendation of gradually 
increasing the exercise duration (in minutes) each week and the exercise intensity each month.  
D7j. 
Co-interventions  
Participants will continue to be followed by their treating physicians/providers for all medical care 
unrelated to the trial. This includes continuation of other medications as prescribed, clinic visits, and 
other care as usual. Specifically, use of medications, and specialist consultations (rehabilitation, pain 
management, and rheumatology) for fibromyalgia will be permitted (and assessed), both to adjust for 
co-intervention differences between arms in the analyses and to assess as secondary outcomes.  
D8. DATA COLLECTION PROTOCOL 
The schedule of outcomes and key variables to evaluate the effectiveness of the POYSE interventions 
are listed in Table 3. After obtaining informed consent (Appendix 3), a research assistant will 
administer a baseline assessment to gather socio-demographic data, body mass index, review the 
patient’s history emphasizing previous treatments tried for their fibromyalgia, and administer several 
validated measures to assess fibromyalgia related symptoms, function, pain, and psychological status. 
The data collection protocol is informed by the Outcome Measures in Rheumatology Clinical Trials 
(OMERACT) recommendations,97 biopsychosocial conceptual model,79 and our previous studies.66,98 
To minimize the potential for ascertainment bias, the baseline and follow-up assessments will be 
conducted by a research assistant blinded to treatment assignment. The baseline interview will take 
approximately 45 minutes, the 1, 3, 6, and 9 month interviews about 30 minutes. These assessments 
will be completed by our research assistant and generally conducted in-person, unless telephone 
interviews are preferred for veteran convenience. We have found that face-to-face interviews are more 
effective in establishing rapport. Additionally, we have found phone interviews over 30 minutes to be 
burdensome to both patients and interviewers. We have used a battery of measures of similar length in 

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several previous or current trials without over-burdening patients. All measures have been conducted 
both in person and by phone in multiple prior trials. Both types of administration have routinely been 
approved by both Indiana University IRB and VA Scientific Review Committee.  
If participants cannot be scheduled for an in-person interview or reached by phone we have employed 
two strategies to capture all outcome assessments: (1) send a mailed questionnaire to the veteran with 
postage paid, self-addressed envelope to our office; and 2) conduct a face-to-face interview in 
conjunction with the patient’s clinic visit. Veterans occasionally lack transportation to the in-person 
interviews. In this situation, we have previously arranged taxi cab rides to and from our VA.  
To protect against data loss, participant responses are collected in two formats: paper and electronic. 
The interviews and study databases will be designed in Microsoft Access by Mr. Jeff Barnd, MS, one of 
our Center’s data managers. To maintain confidentiality of veterans interviewed, our research assistant 
will adhere to careful interview and data collection procedures. First, participants will be told that their 
responses will remain confidential and that every effort will be made to fulfill that assurance. Second, 
the interviews will be conducted in an appropriate setting (i.e., private interview room). Third, completed 
surveys will be stored in a secure location in our Center in a locked file cabinet.   
D8a.  Primary Outcome Measure 
The primary outcome measure will be the Total Score from the Fibromyalgia Impact Questionnaire 
Revised (FIQR).  The FIQR (Appendix 4) has been found to be a useful brief instrument to assess the 
overall impact and severity of fibromyalgia.99 The FIQR is an updated version of the widely used 
Fibromyalgia Impact Questionnaire (FIQ) which has been extensively used and validated in clinical 
trials. The FIQR consists of 21-items that assess pain, fatigue, stiffness, sleep, depression, memory, 
anxiety, balance, and environment sensitivity.9,99 All items are framed in the the past 7 days and are 
scored on an 11-point numeric rating scores of 0 to 10, with 10 being “worst.” The total score range 
from 0 to 100, with higher scores representing greater symptom burden and functional limitations from 
fibromyalgia. The FIQR has strong internal consistency (Cronbach’s alpha = 0.79 to 0.93) and is 
comparable to the original FIQ allowing comparisons between the FIQ and FIQR.100  In addition to the 
Total Score, the FIQR contains scales for Symptoms (10 items), Function (9 items), and Overall Impact 
(2 items); the most important domains in fibromyalgia trials. Scoring of the FIQR involves: 1) summing 
the score for function (range 0 to 90) and dividing by 3; 2) summing the score for overall impact (range 
0 to 20); and 3) summing the score for symptoms (range 0 to 100) and diving by 2.  The three domains 
are weighted; 30% of total score ascribed to function, 50% to symptoms; and 20% for overall impact.    
D8b.  Measures, Schedule, and Mode of Administration 
In addition to our main outcome measure (FIQR Total Score), we will also measure several other 
secondary outcomes recommended by the OMERACT guidelines97,101 and consonant with the 
biopsychosocial model at each follow-up assessment. These include depression, anxiety, health related 
quality of life, pain beliefs, fatigue, sleep, and self-efficacy. These variables are important to assess as 
key moderators or mediators of intervention effects.  Finally, measures of fitness and physical activity 
as well as measures of satisfaction and adherence to the interventions will be assessed. We will 
also assess the performance of all scales to ensure they meet standard psychometric characteristics. 
Baseline patient characteristics will be evaluated with an interview adapted from our previous pain and 
fibromyalgia trials and will include socio-demographics, disability compensation, comorbid medical and 
psychiatric disorders, and prior treatments for fibromyalgia. We will also regularly assess use of other 
treatments for fibromyalgia (other medications, exercise, physical therapy, complementary and 
alternative medicine modalities, and interventional modalities) as well as prescription medication use. 
For medications, we will record prescribed doses, administration schedule, and number of pills 
prescribed, especially opioid analgesics, antidepressants, and benzodiazepines. 
D8c.   Description of Specific Measures 
Fibromyalgia symptom severity will be assessed with the Fibromyalgia Impact Questionnaire 
Revised (FIQR).9    

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Pain-severity: The Brief Pain Inventory is an 11-item, multidimensional pain measurement tool with 
demonstrated reliability in patients with arthritis as well as other pain conditions.102,103 The BPI rates the 
intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, 
relations with others, sleep, and enjoyment of life. 
Psychological symptoms are frequently associated with fibromyalgia and will be assessed by: 
The PHQ-9 will be used to assess depression severity. Several studies have validated the PHQ-9 as a 
diagnostic measure with excellent psychometric properties.104 Internal consistency has consistently 
been shown to be high (Cronbach's alpha > 0.80) and test-retest assessment showed the PHQ-9 to be 
a responsive and reliable measure of depression treatment outcomes. 
The GAD-7 has demonstrated reliability (alpha = 0.89) and validity (criterion, construct, factorial, and 
procedural) as a measure of anxiety in the general population and primary care.105  
The Primary Care PTSD Screen (PC-PTSD) has been validated for use in VA primary care settings.106 
The sum of the 4 yes/no items yields a score ranging from 0 to 4, with scores ≥ 3 considered positive 
for active PTSD.  Sensitivity is 78% and specificity is 87% compared to clinician interview.107 In 
participants who screen positive, the PTSD Checklist for Military (PCL-17) will be administered. This 
17-item scale assesses the DSM-IV symptoms of PTSD, and is used for diagnosis and as a severity 
measure as a measure of change in PTSD symptoms as a function of treatment.  The PCL has 
demonstrated sensitivity and specificity >70%.107   
Table .  Outcome Assessment Protocol:  Measures and Schedule of Administration 
Domain 
Measure 
 
Items 
Time 
(min) 
  Schedule 
BL 
1 
mo 
3 
mo 
6 
mo 
9  
mo 
Covariates 
Demographics; contact 
information; disability 
compensation, comorbidity; 
pain treatments 
36 
10 
X 
 
 
 
 
Fibromyalgia 
severity 
Fibromyalgia Impact 
Questionnaire Revised 
21 
6 
X 
X 
X 
X 
X 
Pain Severity 
Brief Pain Inventory 
10 
3 
X 
X 
X 
X 
X 
Psychological 
PHQ-9 Depression 
9 
2 
X 
 
X 
 
X 
GAD-7 Anxiety 
7 
2 
X 
 
X 
 
X 
VA PTSD Screener 
4 
1 
X 
 
X 
 
X 
 
VA PTSD Checklist (PCL-17) 
17 
4 
X 
 
X 
 
X 
Generic HRQL 
Medical Outcomes SF-12 
12 
4 
X 
 
X 
 
X 
Fatigue 
Multidimensional Fatigue 
Inventory 
20 
5 
X 
X 
X 
 
X 
Sleep 
MOS Sleep Scale 
12 
3 
X 
X 
X 
 
X 

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Other secondary outcome measures and potential predictors of treatment response will be 
assessed: 
The Medical Outcomes Study Short Form Questionnaire (SF-12) is the criterion standard for generic 
functional status and health-related quality of life.108 The SF-12 assesses physical and mental 
functioning in 8 domains and gives reliable, valid and responsive summary scores.108      
The Multidimensional Fatigue Inventory (MFI) will be used to assess fatigue.109 The MFI assesses 
clinical fatigue in 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, 
and reduced activity. The MFI has been validated among adults with chronic illness, chronic fatigue 
syndrome, and cancer, as well as among healthy adults.110  
Sleep problems will be assessed using the MOS Sleep Scale which assesses sleep disturbance, 
adequacy of sleep, and sleep quantity. The MOS-Sleep Scale has demonstrated good psychometric 
properties in trials assessing pain.111   
The Pain Catastrophizing Scale a 13-item scale that assesses catastrophizing—a pain belief that has 
been found to be strong predictor of poor treatment response.112  Validation studies examining the PCS 
have found strong evidence of criterion-related, concurrent, and discriminant validity.112 
The Centrality of Pain Scale is a 10-item measure to measure how central chronic pain is to a patient’s 
life. 
  
Pain beliefs 
Pain Catastrophizing Scale 
10 
3 
X 
 
X 
 
X 
Pain coping 
Centrality of Pain Scale 
10 
3 
X 
 
X 
 
X 
Self-efficacy 
Arthritis Self Efficacy Scale 
6 
2 
X 
 
X 
 
X 
Treatment 
Response 
Global Rating of Change 
1 
1 
 
X 
X 
X 
X 
Physical 
Function and 
Activity 
Functional Assessment which 
includes Fullerton Advanced 
Balance Scale (FAB) 
18 
10 
X 
 
X 
X 
 
Rapid Assessment of 
Physical Activity 
8 
2 
X 
 
X 
 
X 
Activity Constraints 
20 
5 
X 
 
X 
 
X 
Activities - Specific Balance 
Confidence Scale (ABC) 
16 
5 
X 
 
X 
 
X 
Balance  
7 
2 
X 
X 
X 
X 
X 
Coherence 
Sense of Coherence Scale 
3 
1 
X 
 
X 
 
X 
Substance Use 
Illicit  use and personal/family 
history 
6 
2 
X 
 
 
 
 
Perceived 
Expectations 
EXPECT Questionnaire 
26 
8 
X 
X 
 
 
 

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Study #1211010073 
The Arthritis Self-Efficacy Scale will be used to assess self-efficacy.113  This 8-item scale proved 
sensitive to change in our low back pain trial.114  For each item, patients report their degree of certainty 
on a scale ranging from 1 (very uncertain) to 10 (very certain).   
The Patient Global Impression of Change (PGIC) is a single item measure to assess overall clinical 
response. This validated and reliable global rating scale is often used as the gold standard for 
determining clinically important differences in outcomes115,116 and required by the Federal Drug 
Administration in fibromyalgia trials. The PGIC asks subjects to rate overall improvement in symptoms 
using a single 7-point scale anchored by “very much improved” and “very much worsened”. 
The Rapid Assessment of Physical Acitivity (RAPA) is a 7 item measure of physical activity for use with 
older adults. 
The Activity Constraints is a 20-item measure which assessing seven different types of constraints on a 
5-point Likert scale. 
The Activities – Specific Balance Confidence Scale is a 16-item scale to assess a subject’s balance 
confidence in performing several activities. 
The SOC-3 (3-item Sense of Coherence scale) will be used to measure the 3 dimensions salient to 
resilience and coherence including manageability, meaningfulness and comprehensibility. 
Substance use problems will be assessed by asking questions about the use of others’ prescription 
drugs or street drugs. 
The EXPECT Questionnaire is a 26-item measure assessing the perceived expectations of the subject 
for the intervention.   
A Functional Assessment will consist of monitoring blood pressure, pulse, six minute walk, gait 
analysis, chair sit and reach test, back scratch test, chair stand test and the Fullerton Advanced 
Balance Scale. 
Health Care Utilization and Costs: will be assessed at the end of the 9 month study period for each 
patient using data available in CPRS. This will include all outpatient, rehabilitation, and emergency 
room visits, inpatient days, x-ray and lab tests, medical and surgical consultations, and medications.   
D9. 
STATISTICAL CONSIDERATIONS 
POYSE will involve a 2-arm, parallel group, randomized comparative effectiveness trial. Since 
participants cannot be blinded to treatment assignment, observed outcomes (if positive) could be 
affected by expectation bias. To account for this potential bias, we will assess treatment expectations at 
baseline and account for expectations in our analyses. We will randomize at the patient rather than the 
provider level for two reasons: (1) randomization at patient level saves sample size; and (2) patients 
from the same provider in the two arms will adjust for “provider effect.” Contamination will also be low 
because there is relatively minimal involvement required of VA providers in POYSE.  In addition, 
randomization will be stratified by sex (women or men) and study recruitment site (VAMC or CBOC) 
to avoid potential imbalance of these factors between the two arms. Dr. Yu, PhD (statistician) will create 
a randomization chart to randomize patients in blocks of 4 or 6. 
D9a. 
Sample size 
Our sample size is calculated based on estimated differences of intervention effects between two arms 
on the primary outcome; Fibromyalgia Impact Questionnaire Revised (FIQR) total score at 3 months. 
The FIQR total score is a continuous measure: a 0-100 scale and reflects the average of three 
domains: function, overall impact, and symptoms. In a recently published yoga trial for patients with 
fibromyalgia, Carson et al.61 found a pre-treatment FIQR score of 48.3 (standard deviation = 17.5).  
Post-treatment scores were reduced by 31% (FIQR = 35.5, SD = 17.6, effect size = 0.72) from the yoga 
intervention. In an earlier trial, Mannerkopi et al.118 tested an intervention combining pool exercises with 

20 
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Study #1211010073 
cognitive behavioral relaxation techniques and found a 13.6% reduction in FIQR scores. From these 
studies, we estimate the difference between the yoga and structured exercise group is 17%. A 
between-group treatment difference of 14% reduction in symptoms represents a minimum clinically 
meaningful intervention effect.119 To be conservative, we will assume a 14% difference between 
treatment groups. The absolute score difference at 3 months is estimated to be approximately 7 points 
(6.79, 14% of 48.3). Assuming a common standard deviation of 17.6 and using a two-sample t-test, we 
will need 107 evaluable subjects in each arm to detect such a difference with >80% power and 5% 
Type I standard error rate.  
We recognize the correlation of outcomes from subjects within the same yoga or exercise class 
may reduce the effective sample size compared to the same sample with independent 
observations.  This possible “clustering effect” seen in group delivered interventions has 
implications for power. We have no preliminary data to estimate the intra-cluster correlation 
(ICC) for participants within the same group. However, based on similarly designed published 
studies, we expect the ICC to be relatively small and balanced across the two treatment arms 
since the cluster sizes will be similar.120 Conservatively, we assume an ICC of 0.02 for both 
treatment groups. With 8 subjects per treatment group/class or cluster, the design effect is 1+ 
(8-1) ×0.02 =1.14. Therefore, we will inflate our sample size by 14% to accommodate the 
potential clustering effects. We then need 122 evaluable subjects in each arm. With a 
conservative 20% attrition, we will then need (122*2)/0.80 = 306 subjects (153 in each arm).   
D9b. 
Data analysis: Baseline characteristics of POYSE sample  
We will examine baseline characteristics (socio-demographic variables, medical and psychiatric 
comorbidity, duration of fibromyalgia, and current and prior pain treatments) of the POYSE sample.  To 
evaluate the representativeness of study enrollees among all eligible patients, we will compare the 
enrollees and those who decline enrollment on their demographic characteristics.  If there are 
systematic differences, these will be considered in the interpretation of the results of subsequent 
analyses. We will also examine differences in baseline characteristics between patients who remain in 
the study and those who dropout. Two-factor ANOVA models which include dropout status, treatment 
group (YOGA vs. SEP) and their interaction will be used for continuous variables.  Logistic regression 
models with the same terms will be used for dichotomous variables.  
D9c. 
Main analysis of the primary outcome (FIQR total score)  
Our main analysis will employ a repeated measurement analysis of covariance (ANCOVA) model 
which is more powerful than two-sample t-test when the baseline outcome measurement is 
positively correlated with post baseline outcome.121 We plan an intent-to-treat analysis approach 
with the primary endpoint at 3 months and evaluation of “early” response at 1 month and 
“sustained” response at 3 and 6 months post-intervention. We will summarize this primary 
outcome at each time point (baseline, 1, 3, 6, and 9 months) for both arms. The difference 
between time points will be compared.  
Since the primary outcome (FIQR total score) is measured repeatedly at baseline, 1, 3, 6, and 9 
months, we will fit a repeated measurement analysis of covariance (ANCOVA) model with the 
four post baseline (1, 3, 6, and 9 months) FIQR total score as the response variables. The main 
predictors will be group (treatment arm), time (categorical), and their interaction. The model will 
be adjusted for baseline FIQR score. A random intercept will be used to adjust for the patient 
effect and to accommodate the correlation among the repeated measurements from the same 
patients. Another random intercept will be used to adjust for the potential clustering effect for 
patients in a specific yoga or exercise group. The primary analysis will evaluate the difference in 
FIQR score between the two treatment arms at 3-months (the primary end point) using 
appropriate contrast in this model. The sustained effect of intervention will be evaluated using 
appropriate contrast for the difference in FIQR change from 3-month to 6-month in this model. 
D9d. 
Secondary analysis of primary outcome 

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Study #1211010073 
For the FIQR total score, we will also define the patients with more than 30% reduction as 
“responders.” We will then compare the probability of responders between treatment arms using a 
generalized linear mixed model with a logit link. The responding status of each patient at 1, 3, 6, and 9 
months will be used as the outcome variables. Main predictors are group (treatment arm), time (1, 3, 6, 
and 9 months), and their interaction. A significant coefficient of group indicates a significant odds ratio 
of being a responder between the two arms at each time point. Each of the three domains of the FIQR 
score will be analyzed in the similar way to the total score. 
 
 
D9e. 
Analysis of secondary outcomes 
Since POYSE is not specifically powered for the secondary outcome, these results should be 
interpreted cautiously unless they are highly significant (p < .001). Pain severity as assessed by the 
Brief Pain Inventory will be analyzed using a repeated measurement ANCOVA model in the same way 
as the FIQR total score. BPI measurement at 1, 3, 6, and 9 months will be used as the response 
variable. Main predictors will be intervention group, time (categorical), and their interaction adjusted for 
the baseline BPI score. A random intercept of subject effect will be used to accommodate correlation 
within subject. Another random intercept of either a specific yoga or exercise group will be used to 
accommodate correlation within group (clustering effect for group delivered intervention).    
Psychological symptoms: PHQ-9 score, GAD-7 will be analyzed using a repeated measurement 
ANCOVA model in the same way as the FIQR total score with repeated outcomes at 1, 3, 6, and 9 
months as the response variables, the same set of main predictors and adjusted for baseline outcome 
measurement. The PTSD screening status will be analyzed using a generalized linear mixed model 
with a logit link. The main predictors will be intervention group, time (categorical) and their interaction 
adjusted for baseline PTSD screening status. PTSD severity from PTSD checklist for military will be 
analyzed similarly. 
Other secondary outcome measures: The analytical strategy for other outcomes will be similar to the 
FIQR total score. These outcomes include SF-36, MFI, MOS Sleep Scale, Pain Catastrophizing Scale, 
Arthritis Self-Efficacy Scale, and PGIC. 
We will employ several secondary analyses to assess the effectiveness of the treatment arms 
compared to each other in improving: 
• 
Individual fibromyalgia symptoms (pain, fatigue, sleep quality, function) 
• 
Health-related quality of life 
• 
Patient global impression of change 
• 
Pain beliefs and self-efficacy 
Analytic techniques will be similar to those previously described. Since there will be a number of 
secondary outcomes, we will account for multiple-comparisons in analyses. We will use the Bonferroni 
approach to adjust for statistical significance threshold when the number of tests is less than 20. 
Otherwise, we will use the false discovery rate (FDR)122 to control the magnitude of false positives. We 
will also stratify our analysis based on a baseline depression status (PHQ-9).  Our previous research 
indicated that 30% to 40% of patients will have clinically significant depression, which may adversely 
affect pain outcomes. Thus, depression is a potential moderator.    
D9f. 
Missing data 
Missing data are unavoidable in longitudinal studies. Based on our prior studies, we anticipate a 
possible dropout rate between 8% and 12%. However, we conservatively estimated a possible 20% 
drop out rate which is reflected in the sample size calculation. We will first run a logistic model with 
missing status as the response variable, intervention arm, patients’ demographic characteristics as 
covariates to check whether the missing status depends on the intervention group assignment and 
patient characteristics. Second, our linear mixed-effect model can accommodate missing-at-random (or 

22 
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Study #1211010073 
MAR which is assumed in many trials)123 where no bias will be introduced by ignoring the missing-data 
mechanism. If drop-outs are Missing Not At Random (MNAR), meaning the likelihood of drop-out 
depends on an un-observed outcome, and the missing data mechanism is ignored, potential bias can 
be introduced. We will run sensitivity analyses using complete cases, last observation carried forward 
imputation, other multiple imputation methods including linear mixed-effect model, to compare results 
across these analyses to assess the robustness of the inference.   
 
D9g.  Economic evaluation 
We will conduct cost effectiveness to determine if changes in health care utilization may offset the 
intervention costs between treatment arms. To conduct this analysis, we will use established 
methods124 to estimate direct costs of the interventions and health care spending for study participants 
during the 9 month trial period from the perspective of the VA.   
D9h. 
Costing    
We will use both micro- and gross (average) costing methods125,126 to estimate intervention and health 
care utilization costs, respectively.  Applying VA Health Economics Resource Center (HERC) 
guidelines, we will measure intervention-related activities and their associated costs.125 These 
intervention costs will include: 1) yoga and fitness instructor average salaries plus fringe benefits; 2) 
study materials (yoga mats, eye pillows, DVDs, audio-recordings, ergometers, heart monitors, 
pedometers) provided to intervention patients; 3) parking; and 4) facility overhead.     
We will use VA DSS data to obtain health care utilization and cost estimates for trial participants.  From 
the VA Patient Treatment File (PTF), we will collect hospital discharge date, days of hospital stay, and 
ICD-9 diagnoses (especially primary or secondary diagnoses) of fibromyalgia for each stay and 
determine the cost per admission. From the Outpatient Care File (OPC), we will collect dates of any 
outpatient visits for fibromyalgia, location of care (stop code), CPT codes assigned to each visit, and 
type of provider delivering care. We will classify all visits into rehabilitation, primary care, emergency, 
pain, specialty medicine or surgery, mental health, and other treatments based on clinic codes.  
The number of outpatient prescriptions, especially for analgesic and psychotropic medications, will be 
found in the DSS NDE Pharmacy Datasets from VA Information Resource Center (VIReC).127   
Laboratory and x-ray testing will be collected to determine the number of tests for fibromyalgia 
evaluation and the costs per test. The cost of other care will be obtained from utilization data included 
in VA Austin databases. For non-VA care, covered by the VA, fee basis files will be merged into DSS 
data.128 For non-VA care not covered by the VA, we will we rely on patient self-report of outpatient visits 
and hospitalizations. Since VA utilization data does not include cost estimates, the above mentioned 
data sets will be merged to the HERC average cost datasets to estimate the costs associated with VA 
utilization for each participant.129,130    
D9i. 
   Analysis 
To estimate cost effectiveness, the dependent variable will consist of primary cost outcomes calculated 
from the VA health care system perspective.  Having obtained the relevant VA healthcare utilization 
events, the healthcare event requires valuation, which is the task of assigning a reasonable market-
level dollar for the expense amount. For each patient, outpatient events (visits, procedures, labs, 
medications, etc.) and inpatient DRGs and medical events (procedures, labs, medications, etc.) will be 
captured from these patient-specific administrative datasets. VHA databases provide sufficient 
outpatient and inpatient procedure and associated treatment classifications (by CPT-4, DRG and ICD-9 
codes) to allow valuation. Dr. French has created similar datasets in other VA funded studies and 
publications. For health care utilization and the associated costs, we will compare inpatient days, 
outpatient visits, telephone care, number of prescriptions and radiographic tests. However, we may not 
be able to include inpatient costs because hospitalization may occur rarely during the 9 months of the 
trial and make estimates of between-group differences imprecise.  

23 
v. 10.02.2014 
 
Study #1211010073 
We will compare the two treatment arms with respect to total health care costs. Univariate, bivariate 
and regression techniques for repeated measures will be used to estimate the healthcare events and 
expenditure amounts. If cost data are skewed, log transformations will be performed prior to performing 
regression. An ANCOVA model will be used and contain treatment group (independent variable) and 
adjusted for comorbidities, age, and previous health care cost data collected at baseline as a covariate.     
Costs will be reported in current year’s dollars.  Sensitivity analyses will be used to account for 
assumptions, including changes in intervention costs and changes in costs related to inpatient or 
outpatient services. If the interventions are found to be differentially more effective and costly, we will 
perform a cost-outcome analysis (i.e., incremental cost-effectiveness). We will estimate the effect of the 
interventions on the primary outcome (FIQR total score). The incremental cost to achieve a clinically 
meaningful decrease in FIQR total scores due to the interventions, i.e., the cost-effectiveness ratio, is 
calculated as the difference in intervention costs between the two treatment arms, divided by the 
difference in effectiveness between groups.  
Intervention Costs + (∆ Health Care Costs) 
(∆ FIQR Yoga) - (∆ FIQR Structured Exercise Program) 
 
 
Where ∆ FIQR = change in FIQR score, and ∆ Health care costs = difference two groups 
D10.   PROJECT MANAGEMENT PLAN 
D10a.  Project Timeline 
The 1st quarter in year 1 will involve hiring and training personnel. Important steps will include: (1) 
finalizing treatment protocols for yoga and exercise arms; (2) training the research assistant in 
screening, enrolling, and consenting study participants; (3) programming the electronic medical records 
to identify potential study subjects based on fibromyalgia diagnosis; and (4) obtaining permission from 
individual treating physicians to approach patients of theirs who might be eligible. During the next 2.5 
years, we will enroll 306 participants (randomizing 153 to each group). Enrollment will average 10 per 
month. The 306 participants will be treated for 3 months. Participants will have outcome assessments 
at baseline, 1, 3, 6, and 9 months. Thus, enrollment will be conducted from the 2nd quarter (year 1) 
until the 4th quarter (year 3); the intervention phase from 2nd quarter (year 1) until 1st quarter (year 4); 
and outcome assessments from 2nd quarter (year 1) until the end of study period.  Baseline analysis will 
begin at the beginning of year 4 and conducted during the final 9 months of the study (separate 
baseline, 3 month, and end-of-study analyses). Main reports and manuscripts will be prepared in the 3rd 
and 4th quarters of Year 4.   
POYSE Study Timeline 
Quarters 
Year 1 
Year 2 
Year 3 
          Year 4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Start-up 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
Enrollment  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
Intervention  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
Assessments 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
Analysis 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
Manuscripts 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
 
D10b.  Overall project coordination and facilities 

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Study #1211010073 
Overall project coordination will be led by Dr. Bair (PI) and Ms. Sargent (Project coordinator). Ms. 
Sargent will coordinate all aspects of the project, trouble-shoot any problems, and provide regular 
updates on recruitment progress. Drs. Bair, Schmid, and French have office, meeting and research 
space within the HSR&D Center for Implementing Evidence-based Practice (CIEBP) at the RVAMC.  
Dr. Ang and Dr. Yu’s offices are a 5-minute walk or drive, respectively from CIEBP. Dr. Van 
Puymbroeck will be available for the monthly study-related teleconferences.     
D10c.   Investigator roles 
The proposed project will be conducted by a strong multidisciplinary team with extensive experience in 
areas relevant to this study. Specific roles of the research team are outlined in more detail in the budget 
justification. The efforts of each of the investigators will be coordinated by Dr. Bair and Ms. Sargent to 
develop plans, review progress, discuss analysis results, and set priorities for the research team. 
Matthew Bair, MD, MS, has expertise in pain interventions in primary care and chronic pain and 
depression comorbidity. He will serve as PI and provide overall study direction. Dennis Ang, MD, MPH, 
is a rheumatologist-investigator with expertise in fibromyalgia clinical and translational research. He will 
serve as the study’s clinical content expert.  Arlene Schmid, PhD, OTR is an occupational therapist-
investigator and will contribute her expertise in developing and testing yoga interventions in veterans 
and relevant rehabilitation outcomes.  Marieke Van Puymbroeck, PhD, CTRS, is a rehabilitation 
scientist and recreational therapist with extensive yoga research experience. She will assist in ensuring 
fidelity and excellent quality of yoga therapy. Kristine K. Miller, PT, MS is a physical therapist and will 
train and supervise our fitness instructors in delivering the structured exercise program. Dustin French, 
PhD, is a health economist-investigator with extensive experience in VA large database research. Dr. 
French will guide the economic analysis. Zhangsheng Yu, PhD, is an experienced clinical trial 
biostatistician who will lead the data analysis. Additional analytic support will be provided by James 
Slaven, MS, who specializes in hierarchical and longitudinal analyses.  Nancy Schalk, YT will deliver 
the yoga intervention. Christy Sargent, BA, will serve as project coordinator, Amanda Gerwig, BS as the 
research assistant, and Jeff Barnd, MS as the data manager.  
D10d. Data Management 
Each of the study questionnaires will be programmed into a desktop computer using Microsoft Access. The 
research assistant will interview the patient and enter data simultaneously into the Access program. Within the 
Access program, algorithms will be created to check for inappropriate or missed data entry. Computer algorithms 
will also automatically score the questionnaires and store the summary scales within the same database, as well 
as determine the appropriate date for follow-up interviews. These data will be backed up daily onto a secured 
server at RVAMC. Participant social security numbers, names, addresses and other personal information will be 
restricted to authorized personnel to protect confidentiality. For data analysis and other uses of the data, this 
information will be removed from the database and be replaced with a simulated identification number. This 
strategy has been used in our previous trials to screen and enroll patients, accurately complete follow-up 
assessment, and protect patient privacy. We have experience in setting up data integrity protocols and data back-
up to minimize the risk for lost or inaccurate data.  
D10e. 
Data Safety Monitoring Plan 
The following multi-component Data Safety Monitoring Plan has been used in our VA RR&D-funded 
ESCAPE trial of OEF/OIF veterans with chronic musculoskeletal pain and NIMH-funded 
pain/depression SCAMP trial. Subjects are monitored during study interventions in the following ways: 
1) frequent subject contacts by research team members.  Responses to the interventions, as well as 
side effects from them are closely monitored. All interview responses are part of the study database. 2) 
Monthly Executive Committee Meetings.  The PI and co-investigators meet monthly for Executive 
Committee meetings.  At these meetings the investigators discuss recruitment, subject safety, protocol 
adherence, and any other issues that may arise.  Minutes are kept and are circulated to any co-
investigators not able to attend.  Subjects will be allowed to withdraw from the trial at any time.  If a 
patient withdraws, we will determine the reason for withdrawal.  Possible reasons will include: 1) death, 
2) worsening of comorbid medical conditions making follow-up impossible, 3) treatment side effects, 
and 4) other.  If subjects withdraw, we will attempt to obtain their permission to complete the remaining 

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outcome assessments. We will establish a local Data Safety Monitoring Board (DSMB) that meets 
every 6 months during the study and is notified via email of all deaths and SAEs at the time of local IRB 
notification. Members will consist of non-study investigators and will include a pain specialist, a 
rheumatologist, a clinical trialist, a nurse, and a biostatistician.   
The DSMB will monitor the following: (a) subject recruitment, accrual, and retention; (b) patient 
outcomes and adverse events; (c) subject safety, privacy, and confidentiality procedures; (d) diversity 
of subject enrollment (i.e., sex and race); (e) data quality and major findings in terms of treatment 
benefits and risks; (f) results of related studies that impact subject safety; (g) assessment of scientific 
reports that might alter the benefit/risk ratio of the study.  Analyses of data will be performed by the 
study biostatistician but will be independently interpreted by the DSMB (which will include an 
independent biostatistician) which can request additional analyses as the DSMB members see fit.  
Since this is an effectiveness trial using evidence-based treatments, there are no pre-planned interim 
analyses or stopping rules. The DSMB will submit the report of its annual meeting to the study 
investigators who will in turn report the information to IRB in its continuing review, unless there are 
items DSMB feels should be reported to IRB immediately. 
D11. 
DISSEMINATION AND IMPLEMENTATION PLAN   
The VHA National Pain Management Strategy Coordinating Committee will serve as our primary 
channel for disseminating study findings to VA providers, administrators, researchers and policy 
makers.  Findings will be disseminated to the committee in the form of summary reports and 
presentations given either in the monthly conference calls or at their annual face-to-face meeting (or 
both). The Committee will advise and coordinate next steps for dissemination, including dissemination 
to other relevant entities such as VISN and hospital administrators; local Pain Management 
Committees; the VISN Pain Points of Contact, the Office of Quality and Performance; and the national 
working groups related to pain management education, guideline development, and performance 
measures.  Additionally, a summary of study findings and implications will be posted on the VHA Pain 
Management Committee’s website in a format readable to veterans.  Findings will be disseminated to 
our research audiences through scientific presentations and publications, and VA cyber seminars, as 
well as through conference calls with the Pain Research Working Group, a subcommittee of the VHA 
National Pain Management Strategy Coordinating Committee.   
We also will seek synergistic opportunities with the Pain Research, Informatics, Medical comorbidities 
and Education (PRIME) Center directed by Dr. Robert Kerns (VA National Program Director for Pain 
Management).  Other resources include a VA national pain management website; a widely subscribed 
VA pain list serve; monthly national educational teleconferences targeting providers and administrators; 
a network of VISN Pain Points of Contact who hold monthly teleconferences and who serve an 
important liaison role between the National Pain Management Committee and facility level pain 
committees; and a network of VA and non-VA pain-relevant investigators (the Pain Research Working 
Group) who hold twice monthly teleconferences and yearly face-to-face meetings and who, among their 
goals, work to promote dissemination of research findings and to influence practice and policy related 
to pain care. In sum, an established network of resources is already in place to disseminate study 
findings. Our research group has disseminated study findings in the VA Cyber-seminar forum 
sponsored by the Center for Information Dissemination and Education Resources (CIDER).   
D12. 
POTENTIAL LIMITATIONS OF PROPOSED STUDY 
Generalizability: The study sample will be drawn from a single, VA medical center and three VA 
community clinics in Indiana. As such, the sample may not be representative of all patients with 
fibromyalgia. However, the treatments under study could certainly be applied in other VAMCs/CBOCs.   
Study design: Our research team thoroughly discussed and debated study design issues. In the end, 
we agreed to frame POYSE as a fully powered, 2-arm comparative effectiveness trial. However, we 
strongly considered a 3-arm study to compare yoga vs. structured exercise vs. wait-listed usual care. 
However, we rejected this alternative for two reasons. The first was pragmatic:  it would be difficult to 
enroll a 50% greater sample size at a single site and this design would add substantially to the trial 

26 
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Study #1211010073 
costs. Second and more importantly, findings from our recent pain trials have demonstrated the 
ineffectiveness of usual care for chronic pain management, making a wait list control of less relevance.  
Multi-component intervention: The POYSE trial involves a multi-component, yoga intervention that will 
primarily test the “bundled” effect (combination of yoga poses, relaxation, and meditation practices) on 
reduction of overall fibromyalgia severity and associated symptoms. Determining the relative effects 
of the individual yoga components will be difficult, but not impossible.  While we considered a 
study of a less complex intervention, a multi-modal approach is best suited to handle the 
complexities of fibromyalgia management based on the biopsychosocial model. We also 
considered either eliminating the meditation component completely or delivering the 
components sequentially in a stepped-wise fashion rather than concurrently an as an 
integrated, mind-body, intervention. However, for historical, philosophical, and logistical 
reasons we decided to deliver the “bundled” yoga intervention as originally proposed.  
To help determine the relative effects and “unbundle” the individual yoga components, we 
propose two strategies.  First, we will conduct post-study, in-depth interviews of a subsample of 
study participants who receive the yoga intervention. Interview questions will focus on 
perceptions of which yoga component was most or least helpful, which yoga exercises did 
participants use most (or least) at home, and patient recommendations to create a “yoga 
toolbox”, i.e., the yoga exercises viewed most effective to reduce fibromyalgia symptoms.  
Based on our experience with similar qualitative studies, we expect to conduct approximately 
25 interviews to improve our understanding of the relative value patients place on the different 
yoga components (poses, meditation, breathing exercises). We have found qualitative work like 
this to be highly informative in elucidating trial results. Second, since we expect each 
component to be an active ingredient, we plan to quantify these components and examine 
whether there is a dose-response relationship between each component and the primary 
outcome. We will not control for differential use of components in our main analysis because 
our main goal is to determine the overall effectiveness of a multi-component yoga intervention.  
D13.    STRENGTHS AND SYNOPSIS OF STUDY 
Despite the study limitations, the POYSE trial has a number of strengths, including: (1) testing the 
comparative effectiveness of two unique interventions designed to improve the management of 
fibromyalgia; (2) management approaches that challenge existing treatment paradigms for fibromyalgia 
care and have the potential to be applied across multiple VA clinical settings; (3) a focus on a 
significantly understudied fibromyalgia population (men and veterans); (4) a clinical condition that has 
become frustrating to VA providers; (5) a randomized clinical trial design; (6) ample statistical power to 
detect meaningful differences in our primary outcome; (7) a large sample size relative to previous trials 
of yoga and exercise; and (8) an economic evaluation that may provide VA administrators, clinical 
managers, and policy makers with data to inform budget decisions to invest in these interventions and 
make them routinely available to veterans suffering from fibromyalgia.   
In sum, VA providers are faced with numerous challenges in treating patients with fibromyalgia. The 
interventions being tested in the POYSE trial have the potential to provide primary care settings with 
new treatment models that will help to guide VA providers while at the same time providing much 
needed relief for veterans suffering from fibromyalgia. 
  
 
 
 
 
 
 

27 
v. 10.02.2014 
 
Study #1211010073 
Class # 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
 
 
Supine, seated 
and standing 
practices.  
 
Supine, seated, 
standing, hands 
and knees   
 
Supine, seated, standing, hands and knees and prone poses 
Introduction: greetings, goals, 
benefits, science behind practices.   
Intro-
duction  
Participants will be reminded of these principles throughout course, including interjection of yoga 
principles/philosophy when relevant. 
Seated or supine  
Seated while learning the practices  
Once learned, practices are done lying on back 
Breathing / Pranayama 
Awareness of breath throughout each session 
• 
Ujjayi Breathing  
Intro-
duction 
Ujjayi breathing taught first class and practiced throughout all sessions 
• 
3 Part Breathing 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
• 
establish personal “home 
base”:  bandhas and 
breath 
Intro - 
duction 
X 
X 
 “Home base”  is reviewed and practiced throughout our course together  
and as needed for grounding in the moment if/when emotions  
or sensations escalate out of the window of tolerance:   
awareness of breath in lower torso with root and belly bandhas  
1. 
deeper breathing 
X 
X 
X 
2. 
mula (root) bandha  
 
X 
X 
3. 
uddiyana (belly) bandha 
 
 
X 
• 
2 to 1 Extended Exhale 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
• 
Alternate Nostril Breathing 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Relaxation w/breath focus 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Eye position and movements 
 
• 
Drishti 
Intro - 
duction 
Drishti (gaze/holding eyes steady) is taught and practiced throughout all sessions. 
• 
horizontal 
X 
X 
X 
X 
X 
Practiced in closing relaxation 
• 
circles/clock numbers 
X 
X 
X 
X 
X 
• 
diagonal/hourglass 
X 
X 
X 
X 
X 
• 
cup eyes in darkness 
 
 
X 
X 
X 
Seated series  
Seated in chair or on floor with cushion/support as appropriate 
• 
Neck movements 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
• 
Lion Face Pose 
 
 
X 
X 
X 
X 
 X 
X 
X 
X 
X 
X 
• 
Scapular movements, 
Cactus/Scarecrow Pose 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
• 
Seated upper back arch    
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
• 
Seated side bend  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
• 
Seated twist 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
• 
Seated “4”  Forward Fold 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
APPENDIX A  - POYSE Study 
with Dr. Matthew Bair  
 
 

28 
v. 10.02.2014 
 
Study #1211010073 
Date 
 
 
 
 
Blood Pressure 
 
 
 
 
Aerobic Exercise 
LE ergometer 
Time (min:sec)/HR 
 
 
 
 
UE ergometer 
Time (min:sec)/HR 
 
 
 
 
Steps 
Time (min:sec)/HR 
 
 
 
 
Beginning Strengthening  Exercises    
Biceps Curls 
Sitting/Standing/Ball 
Repetitions 
Resistance 
 
 
 
 
Shoulder Press 
Sitting/Standing/Ball 
Repetitions 
Resistance 
 
 
 
 
Ball Hug 
Sitting 
Repetitions 
Ball 
 
 
 
 
Squat 
Sitting/Standing/Wall 
Repetitions 
UE add-in 
 
 
 
 
Bridge 
Supine/Ball 
Repetitions 
 
 
 
 
Lower Trunk Rotation 
Supine 
Repetitions 
Resistance 
 
 
 
 
Crunch 
Supine/Ball 
Repetitions 
Rotation add-in 
UE add-in 
 
 
 
 
Scapular Retraction 
Prone/Ball 
Repetitions 
UE position  
 
 
 
 
Hip Abduction 
Supine/Side/Standing 
Repetitions 
Resistance 
 
 
 
 

29 
v. 10.02.2014 
 
Study #1211010073 
 
Date 
 
 
 
 
 
 
Strengthening Exercise Moderate Progression Options   
Side Lateral Raises 
Sitting/Standing/Ball 
Repetitions 
Resistance 
 
 
 
 
Upright Rows 
Standing 
Repetitions 
Resistance 
 
 
 
 
Triceps push-up 
Sitting 
Repetitions 
Up/Anterior 
LE placement 
 
 
 
 
Upper Trunk Rotation 
Sitting/Standing 
Repetitions 
Resistance  
 
 
 
 
Rear Delt Raises 
Side/Ball 
Repetitions 
Resistance 
 
 
 
 
Lunge 
Standing 
Repetitions 
UE add-in 
 
 
 
 
Advanced Strengthening Exercise Options  
Push-up 
Prone/Ball 
Repetitions 
 
 
 
 
Plank 
Prone/Ball 
Repetitions 
Time 
 
 
 
 
Reciprocal Arm/Leg Lift 
Quad 
Repetitions 
Resistance 
 
 
 
 
Lunge and Turn 
Kettlebell 
Repetitions 
Resistance  
 
 
 
 
Around the Body Pass 
Kettlebell 
Repetitions 
Resistance 
 
 
 
 
Date 
 
 
 
 

30 
v. 10.02.2014 
 
Study #1211010073 
Figure 8 
Kettlebell 
Repetitions 
Resistance 
 
 
 
 
Swing 
Kettlebell 
Repetitions 
Resistance 
 
 
 
 
Swing-Snatch 
Kettlebell 
Repetitions 
Resistance 
 
 
 
 
Stretches 
Upper Trap 
Repetitions/Time (sec) 
 
 
 
 
Levator Scapulae 
Repetitions/Time (sec) 
 
 
 
 
Lateral Trunk Flexion 
Repetitions/Time (sec) 
 
 
 
 
Trunk Rotation 
Repetitions/Time (sec) 
 
 
 
 
Hamstring 
Repetitions/Time (sec) 
 
 
 
 
Heel Cord 
Repetitions/Time (sec) 
 
 
 
 
Quad (LH) 
Repetitions/Time (sec) 
 
 
 
 
Pecs 
Repetitions/Time (sec) 
 
 
 
 
Lats/Gluts Stretch 
(prone) 
Repetitions/Time (sec) 
 
 
 
 
Staff Name 
Initials (indicate which dates you helped direct exercises for participant)