Qigong for Multiple Sclerosis: A Feasibility Study
Phase: NA
Conditions: Multiple Sclerosis
Sponsor: National University of Natural Medicine

 
 
 
Study Protocol 
Qigong for 
Multiple Sclerosis: 
A Feasibility Study
NUNM IRB#: 102015 
 
10-6-2016 
 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
1 
 
 
 
 
 
 
Title of Study:  Qigong for Multiple Sclerosis: A Feasibility Study 
 
Principal Investigator:  Dr. Angela Senders, ND, MCR (503) 552-1743   
Student Investigator: Lita Buttolph, PhD (503) 552-1886 
Clinical Investigator: Dr. Paul Kalnins, ND, MSOM (503) 552-1551 ext. 1774  
IRB#: 102015 
Version#: 10-06-16 
Document Approval Date: 10/06/16 
 
ABSTRACT 
 
Background: Multiple Sclerosis (MS) is a chronic, autoimmune disease of the central nervous 
system that affects over 2.3 million people worldwide.1  People with MS can experience a 
variety of symptoms, including impaired motor function and balance, fatigue, pain, impaired 
cognition, and depression. Ancient Chinese movement arts, such as taiji and qigong, have been 
shown to improve quality of life, balance and fatigue in a variety of chronic conditions.2–8 
However, very little published research has been conducted on the effect of these practices 
specifically for people with MS.9   
 
Objective: The primary goal of this study is to assess the feasibility of weekly community 
qigong classes for people with MS. A secondary goal is to test the effect of weekly community 
qigong classes on quality of life, balance, and gait for people with MS.   
 
Participants and Design: In this non-blinded randomized controlled feasibility trial, twenty 
adults with any type of MS will be randomized to either a qigong intervention (n=10) or wait-list 
control group (n=10). The intervention group will participate in 60-to-90 minute community 
qigong classes once a week for 10 weeks. Participants will choose from four vetted qigong 
instructors and will select a class that is geographically convenient and fits their schedule.  This 
pragmatic design maximizes external validity by reflecting the ways in which people with MS 
initiate qigong practice in the real world. Feasibility outcomes include recruitment, adherence to 
the qigong intervention, and ability to participate.  Secondary outcomes include validated 
measures of quality of life (PROMIS, the Multiple Sclerosis Impact Scale), balance (the Four 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
2 
 
Square Step Test), gait (the MS Walking Scale, Timed 25-Foot Walk Test, and Timed-up and 
Go), and fatigue (PROMIS, Modified Fatigue Impact Scale) collected at baseline and 10 weeks. 
 
Results from this trial will provide preliminary data to seek future funding for a fully powered 
randomized controlled trial of qigong and MS. 
 
A. SPECIFIC AIMS 
 
Aim 1: To assess the feasibility of weekly community qigong classes for people with any type of 
MS. Specific feasibility outcomes include (1) ability to recruit and enroll participants with MS; 
(2) adherence to the intervention protocol as measured by class attendance and home practice; 
and (3) ability of participants to take part in qigong exercises. 
 
Aim 2: Assess the ability of weekly community qigong classes (n=10) compared to wait-list 
control (n=10) to improve balance, mobility,  quality of life, and fatigue for people with MS. 
Validated outcome measures will be administered at baseline and immediately post-intervention 
and include quality of life (PROMIS, the Multiple Sclerosis Impact Scale), balance (the Four 
Square Step Test), gait (the MS Walking Scale, Timed 25-Foot Walk Test, and Timed-up and 
Go), and fatigue (PROMIS, Fatigue Severity Scale). 
 
Because this is a small feasibility study, the data collected are meant to be hypothesis-generating. 
Any clinically meaningful trends toward improvement will justify further exploration of qigong 
for MS. 
 
B. BACKGROUND AND SIGNIFICANCE 
 
Multiple Sclerosis (MS) is a chronic, autoimmune disorder affecting the central nervous system.1  
The National MS Society estimates that 2.3 million people globally have MS.1  The National 
Institute for Health estimates that 250,000 to 350,000 people are diagnosed with the disease in 
the US, with an estimated 200 new cases each week.10   Medications have been shown to slow 
the progression of the disease and help manage symptoms, although they often come with 
adverse side effects ranging from mild to severe (e.g., nausea, vomiting, hemorrhagic cystitis, 
and cancers).11,12 
B.1. SYMPTOMS AND DISEASE STAGES  
Multiple Sclerosis results in damage to the myelin sheath and nerve fibers of the central nervous 
system (CNS). Symptoms vary depending on where in the CNS the damage occurs.  Some of the 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
3 
 
most common symptoms of MS include vision problems, muscle weakness, gait dysfunction, 
poor balance, numbness and/or prickling sensations, bowel and bladder dysfunction, fatigue, 
dizziness, vertigo, sexual dysfunction, pain, depression, decreased memory, and decreased 
cognitive ability.13  
There are currently four identified courses of MS, each of which may appear in mild to severe 
form.  These include (1) Relapsing-Remitting; (2) Primary-Progressive; (3) Secondary-
Progressive; and (4) Progressive-Relapsing MS (Table 1). 
 
Table 1. Courses of MS1 
Course of MS 
Characteristics 
% of People with 
MS 
Relapsing-Remitting 
(RR-MS) 
Alternating attacks or “flare-ups” of neurologic 
symptoms followed by periods of remission 
85% initially 
receive this 
diagnosis 
Primary-Progressive 
(PP-MS) 
Steady, slow worsening of neurologic function 
from onset with no remission 
10% initially 
receive this 
diagnosis 
Secondary-
Progressive (SP-MS) 
Steady, slow worsening of neurologic function 
with no remission after an initial relapsing-
remitting period 
50% of those with 
RR-MS develop SP-
MS after 10 years. 
Progressive-
Relapsing (PR-MS) 
Steady, slow worsening of neurologic function 
with no remission mixed with episodes of more 
intense “flare-ups” 
5% initially receive 
this diagnosis 
 
B.2. EXERCISE AND MS 
Many clinical trials have investigated the relationship between MS and exercise.14–22 A recent 
systematic review by Latimer-Cheung and others found that people with mild-to-moderate 
disability from MS who engaged in moderate-intensity exercise two times per week benefitted 
from increased aerobic capacity and muscular strength.19  The authors also found that exercise 
may improve mobility, fatigue, and health-related quality of life for people with MS.19  Mayo et 
al. recommend that exercise programs for people with MS be “interesting, relevant to the 
individual, and easily implemented across a variety of settings.”21, (p. 2)  When comparing people 
with MS to people without MS, they found that “people with MS expressed the need to feel safe 
and have clear professional instructions provided on proper techniques, intensity and 
duration .”21, (p.2) These findings suggest that exercise programs that are instructor-led, of 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
4 
 
moderate intensity, allow adjustments to individual needs and restrictions, and are intellectually 
stimulating may be well-suited for people with MS. 
B.3. QIGONG 
Qigong is an ancient Chinese movement art developed to promote health, longevity and well-
being.  Qigong exercises often involve a combination of gentle movements, meditation, breath-
work and visualization.  Taiji (also known as tai chi or tai chi chuan), is similar to qigong but 
includes a martial art/self-defense component. Taiji has been described as a “complex multi-
component intervention integrating neuro-musculoskeletal training, breathing, and various 
cognitive strategies (e.g. imagery, focused attention), often embedded within a rich psychosocial 
framework”23 (p.4)  Both taiji and qigong are mind-body exercises commonly taught in structured 
classes.  Both are growing in popularity due to their reported health benefits, safety and low cost.  
    
A number of scientific studies have documented the health benefits of qigong and taiji.  Several 
clinical trials of qigong and/or taiji have found significant improvements in balance and gait, 
2,4,5,24,25 fatigue,6,7,8,26 and quality of life.8  Several studies of Parkinson’s disease found beneficial 
effects from taiji and/or qigong, including improved balance, mobility, sleep, health-related 
quality of life as well as reduced pain.3–5  Other studies have looked at the effects of qigong on 
fatigue, anxiety and depression in people with Chronic Fatigue Syndrome (CFS), showing 
improvements in these symptoms as a result of qigong practice, along with improved mental 
functioning and telomerase activity.6,7  Two recent studies evaluated the effects of qigong on 
pain reduction for people with fibromyalgia, finding significant improvements in pain, 
psychological health,  and physical function 27,28 
Despite the number of studies looking at the effects of qigong and taiji on neurological disorders, 
there has been very little published research on the effects of qigong and MS.  One pilot study, 
using a sample of 16 people with secondary progressive MS, found statistically significant 
improvements in depression and balance after two-months of one-on-one mindfulness 
taiji/qigong sessions (a total of 6 sessions).29  Despite the promising findings of this study, the  
non-validated symptom rating questionnaire limit its generalizability to a broader population.   
The potentially high cost of one-on-one training sessions may also limit its applicability in the 
real world.    
 
 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
5 
 
C. RESEARCH DESIGN AND METHODS  
 
C.1. EXPERIMENTAL DESIGN 
 
The proposed randomized controlled pilot study will assess the feasibility for people diagnosed 
with MS (n=20) to attend community qigong classes once a week for 10 weeks.  The primary 
goal is to determine the feasibility of the study process (i.e., recruitment, retention, adherence, 
and pragmatic design).  The secondary aim is to assess effectiveness of qigong for people with 
MS, specifically looking at quality of life, balance, gait performance and fatigue.  Potential 
participants will undergo an initial telephone screening for eligibility, followed by an in-person 
visit in which they will review and sign an informed consent form, complete a demographic 
survey, complete the Timed-25-Foot-Walk Test to verify eligibility, and complete baseline 
outcome surveys and tests.  Eligible participants will be randomly assigned to the qigong 
intervention group or a wait-list control group.  The qigong group will be asked to attend 60 to 
90 minute long pre-vetted qigong classes once a week for 10 weeks and encouraged to practice 
daily at home.  Criteria for selecting qigong classes are described in more detail below. To track 
adherence, participants will have an attendance card that they check at each class.  Qigong 
instructors will also keep track of attendance of all study participants.  
Those assigned to the control group will be asked to refrain from qigong, taiji or yoga during the 
10-week trial period.  Following the collection of outcome measures after 10 weeks, the control 
group participants will be given the opportunity to participate in a subsequent 10-week qigong 
intervention. Outcome measures will again be collected immediately after the 10-weeks of 
qigong for the wait-listed control group.  
We chose a pragmatic design to enable participants to 1) select an instructor and qigong style 
they prefer, 2) select a class that fits their schedule, 3) select a class location that is 
geographically accessible, and 4) immediately begin the qigong intervention without waiting for 
other participants to be recruited. We expect these pragmatic benefits to help with recruitment 
and retention of participants. Furthermore, this trial design maximizes external validity by 
reflecting the way people with MS are referred to or encounter qigong in the real world.    
 
C.2. SCREENING AND STUDY ACTIVITIES 
 
All study visits will take place at the National University of Natural Medicine (NUNM) Helfgott 
Research Institute, excluding qigong class, which will occur in separate locations throughout 
Portland.   

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
6 
 
 
C.2.1. TELEPHONE SCREENING 
 
Potential participants will be screened over the phone by the student investigator prior to 
scheduling the first visit.  A standardized telephone script will be used to describe the study and 
determine eligibility.   (See Attachment 2 for copy of telephone script).   If the potential participant 
meets the initial eligibility criteria and agrees to be in the study, he/she will be assigned a study ID 
number and scheduled for Visit 1.   A copy of the consent form will be emailed or mailed to the 
participant for their review at least 24 hours prior to Visit 1.  A list of pre-vetted qigong classes 
and instructors will also be mailed or emailed to participants prior to Visit 1.  This list will include 
a description of each qigong style and brief biography of each instructor.  
 
C.2.2. STUDY ACTIVITIES 
Study Visit 1: Screening and Baseline (Week 1 of the study) 
This study visit will take about 90 minutes.  Participants will be asked to do the following: 
 Review and sign consent form.  
 Complete the Timed-25-Foot-Walk Test (T25-FW) to verify eligibility (i.e., ability to 
walk 50 feet without assistive devices). 
 If participants are able to complete the complete T25-FW they will be asked to complete 
the Four Square Step Test, and the Timed-Up and Go.  
 Complete a demographic/physical activity/treatments/medications questionnaire to 
determine baseline conditions and potential covariates. 
 Complete medications log to document all medications/supplements that participant is 
currently taking. 
 Complete on-line surveys. 
 The study coordinator will review the list of qigong classes and instructors with the 
participant, and answer any questions he/she may have about the pre-vetted classes.  
Based on this discussion, participants will be asked to select a class they wish to attend if 
they are selected to be in the intervention group. 
 
Following Study Visit 1, participants will be randomly assigned to the qigong intervention or 
control group by a pre-established randomization scheme with a block size of four. Some qigong 
classes may not be available to join immediately, depending on the class schedule and number of 
participants already attending the class. Thus “Week 2” may not actually begin one week 
following Visit 1, but will begin once the chosen qigong class is able to accept the participant 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
7 
 
into the class.  The potential delay from Visit 1 to beginning of the intervention period may range 
from one week to up to 2 months.  We will make every effort to time the screening process in a 
way that minimizes wait times for participants. 
  
Weeks 2-11 of the study  
 Participants assigned to the qigong group will attend one pre-vetted 60-90 minute 
community class per week for 10 weeks, and will be encouraged to practice at home.  
 The wait list control group will continue usual activities and care while refraining from 
any qigong, tai chi or yoga. 
 
Study Visit 2 (Week 12 of the study) 
This study visit will take about 60-90 minutes.  Participants will be asked to do the following: 
 Repeat the surveys completed at Visit 1.   
 Repeat the three physical tests completed at Visit 1. 
 Complete medication log follow-up to determine if there have been changes to 
medications/supplements since baseline. 
 Complete an exit questionnaire for those in the qigong group.  
 Wait-list control group members will be invited to join a new qigong group and 
participate in 10 weeks of qigong classes.   
 Wait list control group members who choose not to join the qigong group will be asked to 
complete an exit questionnaire at this visit.  
 
Study Visit 3 (Week 23 of the study – only for control group participants that continue with 
qigong) 
This study visit will take about 60-90 minutes.  Participants will be asked to do the following: 
 Repeat the surveys completed at Visit 1.   
 Repeat three physical tests completed at Visit 1. 
 Complete medication log follow-up to determine if medications have changed since Visit 
1 and 2. 
 Complete an exit questionnaire. 
 
 
 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
8 
 
Table 2. Study related activities. 
  
Visit 1 – everyone 
Qigong  group only* 
Visit 2 - everyone  
Qigong for control 
group only* 
Visit 3 – control 
group only 
Week #: 
1 
2-11 
12 
13-22 
23 
Review consent form and sign if agree 
X 
 
 
 
 
Complete demographic/physical 
activity/treatments/medications 
questionnaire 
X 
 
 
 
 
Complete medications log 
X 
 
X 
 
X 
Complete online surveys 
X 
 
X 
 
X 
Complete physical tests 
X 
 
X 
 
X 
Attend qigong classes (once/week) 
 
X 
 
X 
 
Log home qigong practice 
 
X 
 
X 
 
Complete exit questionnaire 
 
 
X 
 
X 
Expected visit length (hours) 
1 – 1.5 
 
1 – 1.5 
 
1 – 1.5 
*Investigator will call to check-in on participant status weeks 1, 2 and 7 of the intervention. 
C.3. PARTICIPANT RECRUITMENT 
 
Recruitment will begin only after NUNM Institutional Review Board approval has been 
obtained. Prospective study participants will be recruited from the greater Portland Metropolitan 
Area, including NUNM Teaching Clinics, the Oregon Health & Science University (OHSU) 
Multiple Sclerosis Center, the MS Society – Oregon Chapter, and the community at large.  Dr. 
Senders has a joint appointment at NUNM Helfgott Research and OHSU, thus facilitating 
collaborative arrangements between the two institutions.  A draft of the proposed design has 
already been presented to neurologists at the OHSU MS Center and they have agreed to discuss 
this study with patients they think would be good candidates. We will send an email 
announcement through the MS Society Oregon Chapter, which has a mailing list of 
approximately 7500 members. We will give a presentation to the NUNM clinical faculty about 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
9 
 
this study to recruit patients from NUNM clinicians. The NUNM EPIC site specialist identified 
40 people with MS seen at the NUNM Clinics between November 1, 2011 and November 1, 
2014. A waiver of HIPAA authorization will be submitted to allow us to contact these patients 
and notify them of this study.  Flyers about this study will be posted at NUNM, OHSU, and the 
qigong studios selected for this study.  We will also invite qigong instructors selected for this 
study to announce this study to their classes and/or patients to help recruit participants.  All 
recruitment materials will be approved by the NUNM Institutional Review Board.   
C.3.1. INCLUSION CRITERIA   
 
 Adults, age 18 and older 
 Self-reported diagnosis of any type of MS  
 Ability to walk 50 ft. without assistive devices (self-report during phone screen and 
objective demonstration at screening visit using the Timed-25-Foot-Walk Test) 
 At least 3 months stable on disease-modifying medication 
 Willingness to participate in qigong exercises for the duration of the study if selected in the 
intervention group 
 Willingness to avoid qigong, taiji or yoga for the duration of the study if selected for the 
control group  
 
C.3.2. EXCLUSION CRITERIA 
 
 Pregnant or nursing women  
 Self-reported physical or mental illnesses that would prevent attendance and participation 
in qigong exercise 
 Any regular qigong, taiji or yoga practice occurring once a month or more within the past 6 
months 
 MS relapse in the 30 days prior to baseline 
 
C.4. QIGONG INSTRUCTOR RECRUITMENT 
Experienced qigong instructors will be recruited for this study based on inclusion/exclusion 
criteria listed below.    
C.4.1. INCLUSION CRITERIA 
 Five years or more qigong instruction experience (including assistant teaching) 
 Experience teaching qigong to individuals with limited mobility 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
10 
 
 Currently teaches weekly qigong classes (60 – 90 minutes in length) open to any skill level 
 Teaches a qigong form that includes physical movement (vs. meditation only) 
 Classes allow for modifications and seated options for people with disabilities 
 Instructor has safety protocols in place to ensure students can safely do movements 
 Instructor is willing to keep track of attendance of study participants 
 Qigong studio is ADA accessible 
 Willingness to allow study participants to attend classes for free 
 Show proof of individual and studio liability insurance with NUNM added to the policy 
 Must complete HIPAA and sign a Disclosure of Significant Financial Interest (DSFI) 
compliance form. 
 
C.4.2. EXCLUSION CRITERIA 
 
 Qigong classes involving any kind of external martial or fighting component 
 
Lita Buttolph has been a certified qigong instructor since 2005, and has personal and 
professional connections to other qigong instructors in Portland.   Based on the above criteria, 
the following pre-vetted qigong instructors have been identified, and all have expressed a 
preliminary commitment to participate in the study. A detailed description and biography of each 
instructor is provided in the document “Qigong Forms Descriptions.”  
Tamara Staudt, ND,LAc- Jin Jing Gong Qigong 
Classes taught at NUNM, Energy Medicine Room 305, Academic Building 
Class format: Qigong classes all levels (ongoing)   
Current class times: Tuesdays 5:30-6:45 pm 
 
Eva Hosseinion, MD, LAc – Jin Jing Gong Qigong 
Classes taught at NUNM, Energy Medicine Room 305, Academic Building 
Class format: Qigong classes all levels (ongoing)   
Current class times: Thursdays 7:00-8:00 pm 
 
Francine Selke-Minogue - Wild Goose Qigong 
Classes taught at Awakenings Wellness Center, 1016 SE 12th Ave., Portland, OR 97214 
Class format: 16-week instructional classes beginning in late September and February 
Current class times: Wednesdays 9 to 10:30 am 
 
 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
11 
 
Tatiana Kulbakina-Tannenbaum, LMT - Wild Goose Qigong 
Classes taught at People’s Food Co-op Community Room, 3029 SE 21st. Ave., Portland, OR 
97202 
Class format: 16-week instructional classes beginning in late September and February 
Current class times: Wednesdays 9 to 10:30 am 
 
Keivan Jinnah, ND, LAc – Xin Yi Qigong 
Classes taught at Sun Gate Studio, 2215 NE Alberta St., Portland, OR 97211 
Class format:  Qigong classes for all levels (ongoing) 
Current class times: Mondays 9:45 – 11:00 am 
 
All qigong instructors will be asked to sign a Memorandum of Understanding indicating that 
they comply with the criteria listed above and agree to participate in this study. 
Prior to the beginning of the study, all instructors will participate in an orientation about teaching 
people with MS.  This orientation will include a discussion about their involvement in the study; 
understanding and recognizing common symptoms experienced by MS patients; ways to support 
participants; how to recognize a participant having difficulty or overextending; and how to 
handle adverse events.  
 
C.5. OUTCOME MEASURES FOR MS 
C.5.1. Feasibility Outcome Measures 
Feasibility outcome measures include (1) the ability to recruit and enroll participants with MS; 
(2) adherence to the intervention protocol as measured by class attendance and home practice; 
and (3) ability of participants to take part in qigong exercises.  The following table outlines the 
criteria that we will use to assess each of these feasibility outcome measures: 
 
 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
12 
 
Table 3. Feasibility outcome measure and assessment criteria 
Feasibility Outcome Measure 
Criteria Used to Assess Success 
Ability to Recruit/Enroll Participants 20 enrollees within an 8-month period (or 2.5 enrollees 
per month)
Adherence to the Qigong 
Intervention 
Attendance at a minimum of 7 out of 10 classes, and at 
least 2 days per week of home practice.1 Attendance 
will be tracked by the instructor with a sign-in sheet, as 
well as by the participant with a wallet-size punch 
card. Participants will track their home practice with a 
practice log that we will provide.
Ability to Participate 
Participants will subjectively rate their ability to 
participate in the exit survey.  The student investigator 
will check-in with participants via phone during weeks 
1, 2, and 7 of the 10-week intervention and ask about 
ability to participate. We define “ability to participate” 
as how easily participants feel they can follow along in 
class (i.e., fully able to participate, partially able to 
participate, only a little or not at all).  Because qigong 
is a mind-body movement art, if participants are not 
physically able carry out a movement, they will be 
encouraged to visualize the movement.  This is a 
common practice in qigong.  Psychoneuroimmunology 
studies have shown physical benefits from 
visualization.30 Thus, we consider visualization to be a 
valid form of participation. We will ask participants to 
estimate the proportion of movements that are 
visualized (0%, 25%, 50%, 75%, 100%) in the exit 
survey, and in their home practice log.
  
C.5.2. Intervention-Based Outcome Measures 
The following measures were selected based on personal recommendations by neurologists at the 
OHSU MS Center, the recommendations of the International Consensus Meeting for a core set of 
outcome measures for use in exercise studies in MS (ICM),31 and previous analyses of the 
 
1 We based this value on a meta-analysis of attrition and adherence rates for exercise 
interventions in which the authors found attrition ranging from 25-50% and an average 
adherence rate of 66%.40  
 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
13 
 
PROMIS surveys for MS.32 All measures are validated surveys or objective tests commonly used 
in MS research and include a combination of patient-reported surveys and timed physical tests.  
A computerized version of the MS-specific surveys will be used by participants to be consistent 
with the PROMIS online survey, and to reduce the time and potential for errors in transferring 
data from a paper survey to a digital database.  Participants will complete the surveys on an iPad 
available at Helfgott Research Institute.  The student investigator administering the survey will 
assist participants who need help completing the survey. We estimate the surveys to take 20 to 
30 minutes to complete, and 15 to 20 minutes for the physical tests.  .  
C.5.2.a. Patient Self-Reported Surveys   
Patient Reported Outcomes Measurement Information System (PROMIS) 
Health related quality of life measures are commonly used to assess an individual’s current 
health status, often in relation to a specific disease or treatment, and include patient self-reporting 
measures of physical, emotional and social well-being. For this study, we selected the Patient 
Reported Outcomes Measurement Information System (PROMIS), a series of free, online, 
patient reported outcome surveys funded by the National Institute for Health.  This system has 
the ability to perform computerized adaptive tests, which have been shown to reduce survey time 
while maintaining outcomes consistent with conventional surveys.  Senders et al. have validated 
its use for MS patients.32  These authors also found that in addition to providing outcomes that 
correlated highly with legacy surveys, the computerized adaptive tests required less time to 
complete (i.e., 4 minutes versus 15 minutes); reduced missing data; and provided automatic 
scoring that referenced the general population.32  For this study, we selected the following 
PROMIS instruments: global health, physical function, fatigue, anxiety and depression.  Based 
on the findings of Senders et al., completion of all five surveys took an average of 4 minutes to 
complete.32    
 Multiple Sclerosis Impact Scale (MSIS-29) 
 The Multiple Sclerosis Impact Scale (MSIS-29) is a validated core outcome measure for quality 
of life in studies of exercise and MS.31  The MSIS-29 was developed in 2000 as a patient-
administered survey for MS, and includes 20 questions on physical impacts and 9 questions on 
psychological impacts of MS.33 Estimated time to complete: 10 minutes. 
 MS Walking Scale (MSWS-12) 
The MS Walking Scale is a 12-question survey of patient self-reported measure of impact of MS 
on walking ability.34  The test has been rated as excellent on test-retest reliability, internal 

 
 
Protocol Study Title: Qigong for MS 
PI: Dr. Angela Senders 
IRB #: 102015 
Approval Date: 10/06/16 
14 
 
consistency, and criterion validity.31  We included this measure to complement the physical tests 
on balance and gait. Estimated time to complete: 5 minutes. 
 
Modified Fatigue Impact Scale (MFIS 16) 
The Modified Fatigue Impact Scale35 has been recommended by the ICM as a measure of energy 
and drive.  It is recommended over the Fatigue Severity Scale when conducting a multi-
dimensional assessment of fatigue.31  The survey consists of 21 questions that assess physical, 
cognitive and psychosocial aspects of fatigue.  Estimated time to complete: 5 to 10 minutes. 
C.5.2.b. Time-Based Physical Tests 
In addition to self-reported surveys, three time-based physical tests will be administered by the 
student investigator, with possible assistance provided by the principal investigator.  Cinda 
Hugos, MS, PT, researcher and physical therapist at the MS Center at OHSU has agreed to help 
train the student investigator in administering these tests.  Dr. Senders, who is familiar with some 
of these tests, will also provide training to the student investigator.  If, based on the phone 
interview or arrival of the participant to the study visit, we anticipate the need for a second 
spotter, we will ensure that a spotter is available prior to the start of the test.  Since we are 
recruiting individuals who state that they are able to walk 50 feet, unassisted, we anticipate less 
of a need for a second spotter than if this study included individuals with a higher degree of 
disability. 
Four Square Step Test (FSST) 
The Four Square Step Test is a test of a person’s ability to step over objects in four directions. It 
is a common measure of multidirectional mobility for people with MS. Originally developed by 
Dite and Temple in 2002, the FSST has been shown to be reliable, valid, easy to score and 
administer.36  The test consists of lining up 4 canes in a cross on the floor, with the central tips all 
converging, and creating four squares about 1 square yard in size (Figure 1).  To reduce the risk 
of tripping on a cane, we will substitute the canes with colored masking tape to delineate the 
squares. The participant starts by standing in the lower left square (Square 1) and facing Square 
2. The test starts with the participant stepping forward to square 2, stepping right to square 3, 
stepping back to square 4, stepping left to square 1, and then moving back in the opposite order 
(4 to 3 to 2 to 1) while being timed. The participant will be allowed to practice this sequence 
once before being timed. He/she will then be asked to complete the sequence as fast as possible 
with both feet touching each square without touching the borders.  The test will be repeated 

 
 
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twice, with the best time taken as the score.  The student investigator will administer the test and 
spot as needed, along with an extra spotter if the situation requires this.  People unable to face 
forward during the sequence may turn to face the next box prior to stepping.   The test may be 
repeated if the participant touches the tape, loses balance, or is unable to complete the sequence. 
Data collected will include number of seconds to complete the sequence and any observations.    
Estimated time to complete: 2 to 5 minutes.  
Figure 1. Diagram of the Four Square Step Test 
 
  
 
  
 
 
 
 
 
 
 
Timed 25-Foot Walk (T25-FW) 
The Timed 25-Foot Walk is a reliable measure of walking ability and is regularly used as an 
outcome measure in studies of people with MS in relation to mobility.37 The test is administered 
and rated by a trained examiner, and consists of having the subject walk a 25-foot long course as 
quickly and safely as possible while being timed.  Once the subject reaches the end point, he/she 
is asked to turn around and walk back through the course, also while being timed.  Subjects are 
allowed to use devices such as crutches, canes and walkers if needed. The test generally takes 
one to five minutes to complete.  The score given for the test is an average of the time needed to 
complete each of the two trials.  The T25-FW has been shown to have a high inter-rater and test-
retest reliability, as well as good concurrent validity.38 Estimated time to complete: 2-5 minutes. 
Timed-Up and Go (TUG) 
The Timed-Up and Go is a test of muscle function and mobility.39  This test has been 
recommended by the ICM.31  The test begins with the participant sitting in an armchair with 
his/her back resting on the back of the chair and arms resting on the arms of the chair. The 
1
2
3
4
Participants always face this way

 
 
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participant is then asked to stand up and walk 3 m at a comfortable and safe speed, turn around, 
walk back and return to a seated position.  The time that it takes to complete this exercise is then 
recorded.  Estimated time to complete: 2-5 minutes. 
 
D.6. RANDOMIZATION AND BLINDING 
 
Participants will be randomly assigned to the intervention or control group after baseline data are 
collected.  Randomization will include blocking to ensure that both groups have an equal number 
of participants.  Four people will be included in each block: two to the qigong intervention group 
and two to the control group. The creation of the allocation sequence and assignment of groups 
will be conducted by Helfgott statistician Dr. Doug Hanes. As this is a small pilot study, the 
student researcher will not be blinded when administering the surveys and physical tests. 
Participants will not be blinded since the control group will not participate in qigong classes.  
 
D.7. DATA MANAGEMENT 
 
Data collected for this study will include basic demographic information (e.g., name, age, gender, 
race, marital status, employment status, number/age of children), as well as current medication use.  
Data will also be collected from validated surveys and physical tests.  All survey data (including 
the exit surveys and instructor surveys) will be administered through the Research Electronic Data 
Capture (REDCap) data management system.  Data from physical tests will manually be entered 
into REDCap.  Class attendance log information will be manually entered into REDCap.   
 
 
D.7. STATISTICAL ANALYSES 
 
Data will be analyzed using descriptive statistics for the feasibility outcomes, including mean 
number of enrollees per month, mean number of classes attended, mean number of hours of home 
practice per week, mean percent participation, and mean percent visualized movements.  For 
effectiveness outcomes, the primary analysis will involve comparing intervention versus control 
group outcome measures using either an independent t-test or Mann-Whitney U (non-parametric) 
test. Additional analyses will include comparing pre- and post-outcome measures for the 
intervention group, as well as comparing pre- and post-outcome measures among the intervention 
plus wait-list controlled intervention group. Analyses of pre/post measures will be done using a 
paired t-test or Wilcoxon signed rank (non-parametric) test (see Table 2).  In addition to testing for 
significant difference, we will also estimate effect sizes using Cohen’s d statistics, calculated for 

 
 
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either within-group changes with treatment or differences between treatment and control groups. 
Depending on the range of disability in the study, analyses may be stratified by level of disability, 
based on disability questions included in the demographic survey.  We will also explore the 
correlation between number of classes attended plus hours of home practice and outcome 
measures.   
 
Table 4. Statistical analyses for Qigong intervention outcomes 
 
Study Time Period 
Group 1* 
Group 2* 
Statistical Test Used 
Week 2-11 
Tx1 
Cx 
Independent t-test or 
Mann-Whitney U test 
Week 2-11 
Tx1 (pre-intervention)
Tx1 (post-intervention) Paired t-test or 
Wilcoxon signed rank
Week 2-11 + 13-22 
Tx1+Tx2 (pre-
intervention) 
Tx1+Tx2 (post-
intervention) 
Paired t-test or 
Wilcoxon signed rank
*Tx1=Qigong intervention group; Cx = Wait-listed control group (no qigong); Tx2 = Cx before 
and after completed qigong intervention during weeks 15-26 of the study 
 
D.8. POWER CALCULATION AND SAMPLE SIZE  
 
We calculated power for the exploratory analysis of PROMIS Quality of Life (QOL) scores. 
Yost et al. estimated minimally important differences ranging from 3 to 6 points in selected 
PROMIS surveys for cancer patients.41  Using 5 points as an approximate average of these 
differences and the standard deviations for the PROMIS QOL mental and physical health 
summary scores from Senders et al.32 (4.00 and 3.06, respectively), we calculated that a total 
sample size of 16 (10 per group, minus 20% attrition) would provide 71% power to detect a 
mean increase of 5 in PROMIS QOL mental health and 90% power to detect a mean increase of 
5 in PROMIS QOL physical health. (Power calculated using the University of British Columbia, 
Department of Statistics calculator, http://www.stat.ubc.ca/~rollin/stats/ssize/.)   
 
E. HUMAN SUBJECTS 
 
E.1. POTENTIAL RISKS AND HOW THEY WILL BE ADDRESSED 
 

 
 
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This study involves the use of questionnaires and surveys, physical tests, and an exercise 
intervention.  The following table lists the potential risks associated with this study and how 
each risk will be minimized or addressed:  
 
 Table 5. Potential risks and measures to minimize/address risks. 
Potential Risk 
How risk will be minimized/addressed 
Breach of confidentiality 
We will make every effort to protect against the loss of 
confidentiality.  All collection of participant personal information
will comply with HIPAA regulations.  Confidentiality will be 
assured by (1) assigning each participant a unique identification 
number used in place of names for all study forms and data 
collected; (2) keeping all forms and paper records containing 
participant information in a secure, locked file cabinet when not 
in use, which will be accessible only to the PI and student 
researcher; (3) using secure, password protected databases 
REDCap and PROMIS and storing any other electronic data on 
the Helfgott shared drive in password protected folders; (4) 
having all study personnel complete HIPAA training; (5) 
ensuring that participants are not identified by name in any 
reports or publications, nor are data presented in such a way that 
the identity of individual participants can be inferred.  
Questions posed in surveys 
and questionnaires may 
seem personal or 
embarrassing to 
participants. 
We will ensure that participants are made aware, in writing and 
verbally, that they do not need to answer any questions they do 
not feel comfortable answering.  This information will be 
conveyed during the review of the Consent Form, as well as 
when the survey is administered 
Participants may be injured 
during physical tests. 
All study visits and testing will be conducted by Lita Buttolph, 
who will be trained to administer these tests.  Cinda Hugos, a 
PT and researcher specializing in MS at OHSU has agreed to 
help train Lita Buttolph on how to administer the physical tests. 
Dr. Senders is also familiar with these tests and can help with 
training.  Lita will ensure that participants are well aware of 
what is required for the test.  She will also allow participants to 
practice a given test prior to timing.  If a participant requires 
additional spotting assistance during the physical test, a testing 
assistant (either the PI or a trained student assistant) will be 

 
 
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present to prevent any falls or injury. A licensed physician will 
be on site during all study visits.  Lita will ensure prior to each 
study visit that a spotter will be available if needed. 
Participants may be harmed 
or injured while partaking 
in the qigong classes. 
Classroom safety will be carefully monitored by the instructor. 
We will select only instructors who are experienced with 
working with handicapped and health compromised students.  
The number of participants taking the 10-week qigong class 
will also be limited to no more than 3 per instructor, and may 
be less depending on the overall size of the class and the 
discretion of the instructor.  Participants will be encouraged to 
self-monitor their own limits and abilities.  All qigong forms 
selected for this study will have modified and seated options to 
accommodate individuals who are unable to stand for all or 
part of the class.  Participants will have the option of sitting or 
standing during each class.  Qigong instructors will receive an 
orientation prior to the start of the study about working with 
MS patients, including understanding and recognizing common 
symptoms experienced by MS patients; ways to support 
participants; how to recognize a participant having difficulty or 
overextending; and how to handle adverse events.  The qigong 
instructors will encourage all participants to move and work 
within their own range of motion and ability.  Participants and 
instructors will be asked to report any adverse events, and will 
be given the emails and phone numbers of the PI, student 
researcher, and Clinical Investigator.  All adverse events will 
be reported to the IRB.  Participants and instructors will be 
advised to call 911 or seek immediate medical assistance in the 
event of a medical emergency.  
 
 
E.2. SAFETY PROTOCOL 
 
Screening:  The first level of safety is built into the screening procedures via inclusion and 
exclusion criteria.   
 
Participant Check-ins:  The student investigator will make phone calls to qigong group participants 
during Weeks 1, 2, and 7 of the study to check-in with participants and ensure that they feel safe 

 
 
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and comfortable in their classes.  The student investigator will also encourage participants to call 
or email her if any discomfort, injury or concerns arise in a class.    
 
Participant Spontaneous AE Reporting 
Participants will be advised to contact Lita Buttolph and Dr. Senders for spontaneous reporting 
of any adverse events. Any adverse event that requires medical management or decision-making 
will be referred to Dr. Kalnins. In the event of a medical emergency, participants and instructors 
will be advised to call 911 or visit the closest emergency room.  
Instructor Check-in:  All qigong instructors will be instructed to contact the student investigator, 
study PI, or CI immediately if there are any health and/or safety concerns regarding the 
participants.  We will also request that instructors check-in with each participant at each class to 
ensure they are not experiencing any problems.   
 
Removal from the Study:  In the event that a participant experiences pain, discomfort, injury or 
illness they will be seen by the clinical investigator who will decide on a case-by-case basis 
whether or not the participant should continue with or be excused from the study.  
 
Privacy:  Privacy in the context of this study includes confidentiality of data and personal 
information in handling and reporting of data as described above.   
 
 
E.3. DEFINING AND REPORTING ADVERSE EVENTS 
Adverse events will be reported according to the NUNM IRB Adverse Events Reporting 
Procedure.  Adverse events are defined as follows (http://www.nunm.edu/helfgott-
research/institutional-review-board-research-integrity/irb-adverse-events.php): 
Adverse Event (AE): Any untoward medical occurrence in a study participant that may or may 
not have been caused by the study intervention.  An AE may be an unfavorable and unintended 
sign (e.g., abnormal lab finding), symptom (e.g., back pain), or disease that happens during the 
study, whether or not related to the study intervention.  There are 2 types of adverse events:  
Anticipated: Those already included in the protocol and consent form as a potential risk or 
part of the disease being studied. 
Unanticipated: Any serious event (including on-site and off-site adverse events, injuries, 
side effects, deaths or other problems) which, in the opinion of the local investigator, was 

 
 
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unanticipated, serious, and was at least possibly related to the research procedures, 
including: 
 
Any serious accidental or unintentional change to the IRB-approved protocol that 
involves risk or has the potential to recur; 
 
Any deviation from the protocol taken without prior IRB review to eliminate 
apparent immediate hazard to a research subject; 
 
Any publication in the literature, safety monitoring report (including Data and 
Safety Monitoring Reports), interim result or other finding that indicates an 
unexpected change to the risk/benefit ratio of the research; 
 
Any breach in confidentiality that may involve risk to the subject or others; 
 
Any complaint of a subject that indicates an unanticipated risk or that cannot be 
resolved by the research staff; or 
 
Any other serious and possibly related event which in the opinion of the 
investigator constitutes an unanticipated risk. 
Serious Adverse Event (SAE): Any untoward medical occurrence that results in death, is life-
threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results 
in persistent or significant disability or incapacity, or results in a congenital anomaly or birth 
defect. Other important medical events requiring medical or surgical intervention to prevent a 
serious outcome are also included.  Specific definitions of SAEs include the following: 
 
Death:  An event that results in the death of a subject 
 
Life Threatening:  An event, which, in the opinion of the physician, would have resulted 
in immediate fatality if medical intervention had not been taken. 
 
Hospitalization:  An event that results in an admission to the hospital for any length of 
time. This does not include an emergency room visit or an admission to an outpatient 
facility. 
 
Prolongation of Hospitalization:  An event that occurs while the study subject is 
hospitalized and prolongs the subject’s hospital stay. 
 
Persistent or Significant Disability:  An event that results in a condition that substantially 
interferes with the activities of daily living of a subject.  “Disability” is not intended to 
include experiences of relatively minor medical significance such as headache, vomiting 
or accidental trauma (e.g. sprained ankle). 
 
Congenital Anomaly:  An anomaly detected at or after birth or any anomaly that results 
in fetal loss.  

 
 
Protocol Study Title: Qigong for MS 
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 
Important Medical Event: An important medical event may not be immediately life-
threatening or result in death or hospitalization but requires intervention(s) to prevent 
serious outcome based on medical judgment, may jeopardize the subject and may require 
medical or surgical intervention to prevent any of the outcomes listed above. 
Severity: Adverse events, but not SAEs, are categorized into four levels of severity: mild, 
moderate, severe, or very severe.  These categories are defined as follows: 
 
Mild: Transient and easily tolerated. 
 
Moderate: Results in a modification or interruption of the subject’s usual activities or 
care and may require discontinuation of the study intervention 
 
Severe: Results in considerable interference with the subject’s usual activities or care and 
may require discontinuation of study intervention. 
 
Very Severe: Results in the need for urgent medical care and likely requires 
discontinuation of the study intervention. 
Attribution: The relationship between adverse events and the study intervention should be 
evaluated and graded as none, remote, possible, probable, or highly probable. Clinical 
investigators are responsible for determining the relationship between study intervention and 
adverse events.  
The timeline for reporting AEs and SAEs is as follows: 
Anticipated Adverse Events: These will be reported in summary form annually to the IRB during 
continuing review, regardless of whether classified as severe or related to the study intervention. 
Unanticipated Adverse Events: Unanticipated problems will be reported to the IRB within 10 
working days of the investigators being notified of the event. 
Serious Adverse Events: Serious adverse events will be reported the IRB within 24 hours of the 
investigators being notified.  
 
E.3. RECRUITMENT AND INFORMED CONSENT 
 
The NUNM Institutional Review Board will approve all recruitment procedures and the study 
protocol.  The student investigator will subsequently gain consent from the participant during the 
first visit before any data are collected.  She will meet in a private room with the potential 

 
 
Protocol Study Title: Qigong for MS 
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participant and review all aspects of the consent form in detail.    She will explain that 
participation is voluntary, may be terminated at any time, and will not affect their ability to 
participate in future research studies. The student investigator will determine the participant’s 
ability to provide informed consent by asking the following questions: 
 
 Do you understand what is being asked of you in this study?   
 Do you have any questions for me about what is going to happen? 
 Can you tell me how long you will be asked to be in this study? 
 Could you tell me how long you will be asked to participate in a qigong class? 
 
Once the student investigator feels certain that potential participants clearly understand their 
roles, rights and responsibilities, she will ask them to sign an approved written consent form.  
The potential participant will sign the consent form if they agree to the terms stated. The student 
investigator will retain the signed consent form, and a copy of the signed consent will be 
provided to the participant.  The original copy will be filed in a locked filing cabinet in the PI’s 
office.  
 
E.4. POTENTIAL BENEFITS TO PARTICIPANTS 
 
Participants may or may not receive any benefit from partaking in this study.  
 
E.5. INCENTIVES 
 
Neither Qigong Instructors nor study participants will receive incentives for participating in this 
study.  
 
F. IMPORTANCE OF KNOWLEDGE GAINED  
 
By understanding if and how qigong can affect symptoms of MS, this study can help broaden the 
range of possible therapies available to people with MS.  Results from this trial will provide 
preliminary data, direction and feasibility to seek future funding for a fully powered randomized 
controlled trial of qigong and MS.    
 
 
 

 
 
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G. PERSONNEL  
G.1. PRINCIPAL INVESTIGATOR 
Angela Senders, N.D., M.C.R., is an Assistant Dean in the School of Research & Graduate 
Studies and chair of the Integrative Mental Health Program at the National University of Natural 
Medicine (NUNM). She received her doctorate in naturopathic medicine from NUNM in 2005 
and maintained a private practice for six years with a focus on mind-body medicine. In 2011 she 
was awarded a postdoctoral fellowship with the Oregon Center for Complementary and 
Alternative Medicine in Neurological Diseases at Oregon Health & Science University (OHSU) 
to study mind-body medicine in a larger health care context. She completed a master of clinical 
research in 2014 and currently funded by the NIH to investigate the impact of psychological 
stress and mindfulness in multiple sclerosis. 
 
G.2. STUDENT INVESTIGATOR 
Lita Buttolph, Ph.D., has been involved in ecological and social science research for the past 25 
years.  She received her B.A. in ecology and M.S. in Wildland Resource Science at the 
University of California, Berkeley.  For her Master’s degree she was involved in several research 
studies ranging from ecological studies of plant-animal dynamics to social science studies related 
to land use policy, livestock grazing  and fire management.  After completing her Master’s 
degree, she worked as a research assistant conducting research on poverty and community well-
being in rural communities in the Sierra Nevada Mountains in California.  In 1993, she began her 
doctorate in Rangeland Science, specializing in International Rangeland Management at Utah 
State University.  For her dissertation research, Dr. Buttolph studied traditional land use 
management practices and the effects of an international development project on indigenous 
Aymara pastoralists in the Bolivian Andes.   After completing her doctorate, Dr. Buttolph 
worked for 15 years conducting research and outreach in natural resources management and 
policy in the Pacific Northwest.  She participated in long-term evaluations of the socioeconomic 
impacts of the federal Northwest Forest Plan and Economic Adjustment Initiative.   Subsequent 
work included working with family forest land owners to find alternative income sources from 
their land through the harvesting and sale of non-timber forest products, including wild food, and 
medicinal herbs.  Dr. Buttolph has been a qigong practitioner since 1999, and has been a qigong 
instructor since 2004.   She is currently pursuing a doctorate in Oriental Medicine and a master’s 
in Integrative Medicine Research at the National University of Natural Medicine in Portland, 
Oregon.   

 
 
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G.3. CLINICAL INVESTIGATOR 
 
Paul Kalnins, N.D., M.S.O.M., received his N.D. and M.S.O.M. degrees from the National 
University of Natural Medicine (NUNM) in 1998. He currently serves as assistant professor and 
clinical supervisor at NUNM, where he lectures on a variety of topics ranging from physiology, 
embryology, pathology and pharmacology. He is a member of the Helfgott Research Institute and 
has pursued the integration of traditional naturopathic and Chinese medical practices with 
evidence-based biomedicine. In particular, he has explored the synthesis of traditional concepts of 
temperament and terrain, with modern research in genetics-epigenetics, neuroendocrine-
immunology, hormesis, and chronobiology. 
 
 

 
 
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