Improving Function in Older Veterans With Hospital-associated Deconditioning
Phase: NA
Conditions: Frail Elderly, Homebound Persons
Sponsor: VA Office of Research and Development

Title:    Improving Function in Older Veterans With Hospital-Associated Deconditioning 
NCT:  02696382
Version Date:  05.23.2022

1 
 
 
Protocol #: 15-1571 
Project Title: Improving function in older Veterans with hospital-associated 
deconditioning 
 
Principal Investigator: Dr. Jennifer Stevens-Lapsley, PT, PhD 
Version Date: 05.23.2022 
 
 
  
 
I. Hypotheses and Specific Aims:   
 
Hospitalization with subsequent deconditioning (hospital-associated deconditioning) is a common 
and profound contributor to functional decline in older adults.1-3 Skeletal muscle weakness and 
atrophy are commonly observed in older adults with deconditioning after a hospitalization,2,4,5 
leading to development of chronic functional deficits. This is especially concerning for elderly 
Veterans, a population who has lower physical function6 and more comorbidities7,8 at baseline 
than the general older adult population, and therefore may be at even higher risk for developing 
disability in activities of daily living (ADLs) after hospitalization.9 Thus, our research has the 
following aims  
 
Specific Aim 1: To determine if PHIT training, initiated upon discharge from an acute care 
hospital, is as safe and more effective than UC in promoting sustained gains in physical function 
for older Veterans. 
Hypothesis 1.1: There will be greater improvements in gait speed (primary outcome), Short 
Physical Performance Battery Scores (SPPB), modified Physical Performance Test (mPPT), 
Timed Up and Go test (TUG), grip strength, and knee extensor muscle strength in the PHIT 
group compared to the UC group at 60 days following hospital discharge, without increasing 
adverse events. Benefits of PHIT will be apparent at the end of intervention (30 days), will 
increase further at 60 days (primary endpoint), and will persist at 90 and 180 days. 
 
Specific Aim 2: To determine if PHIT intervention, initiated upon discharge from an acute care 
hospital, improves independence in home and community mobility more than UC in older 
Veterans.  
Hypothesis 2.1: There will be greater recovery in the PHIT group in measures of home and 
community mobility, as measured by the Nottingham Extended ADL Index, physical activity (PA) 
monitors, and the Life-Space Assessment (home and community mobility). Assessments will be 
performed at all time-points. 
 
Specific Aim 3: To determine if PHIT rehabilitation, initiated upon hospital discharge, improves 
Veteran quality of life (QOL) & cognition, with concomitant reduction in caregiver burden 
compared to UC. 
Hypothesis 3.1: Veterans in the PHIT group will have higher quality of life [measured by the 
physical function subscale of the Veterans Rand-12 (VR-12)] & better cognition (measured by 
SLUMS) & caregivers will have lower caregiver burden (Caregiver Burden Inventory).10,11 
Assessments will occur at baseline, 60, and 180 days. Veterans in the PHIT group will be more 
informed and motivated healthcare consumers [measured by the Patient Activation measure 
(PAM) at baseline and 30 days]. 
 
II. Background and Significance:  
B.1. Functional decline after acute hospitalization: a hidden epidemic. 
Hospitalization is a profound contributor to functional loss and disability in older adults.1,2 
Considerable evidence exists for hospital-associated deconditioning (HAD),2 including dramatic 
and rapid loss of muscle mass and strength,12 slower walking speed,13 and greater difficulty 

2 
 
negotiating activities of daily living following hospital discharge.14 Therefore, it is not surprising 
that older adults who are hospitalized are 60 times more likely to develop disability.1 
Comorbidities, the concurrent presence of two or more medically diagnosed diseases, further 
exacerbate the sequelae associated with hospitalization.15 This is of particular concern to 
healthcare professionals serving the Veteran population, as this growing population16 has a 
higher prevalence of chronic disease,17 lower level of physical function6 and decreased health-
related quality of life8 compared to their age-matched peers. Furthermore, older adults 
experience a sharp decline in home and community mobility after hospitalization. On average, 
scores on the Life-Space Mobility Assessment—a measure designed to capture activity 
frequency and dependence in the home and community—decrease significantly in older adults 
after hospitalization and remain below pre-hospitalization levels 2 years later.18 Despite these 
significant declines, many of the healthcare efforts for older adults neglect to specifically 
address functional deficits stemming from hospitalization.19,20 Alarmingly, this reduced physical 
activity and function after hospitalization is also strongly and independently tied to hospital 
readmission risk.21 Thus, it appears that many modifiable risk factors (including impaired gait 
speed and lower extremity weakness) may persist as portents of poor health, re-hospitalization, 
or death14 in older adults following acute hospitalization. 
 
B.2. Physical function after hospitalization is a powerful biomarker of health for older adults.      
Although the risk factors for the development of disability are likely to be complex and 
multifactorial, there is evidence to suggest that physical function alone may be a powerful 
biomarker of overall health following acute hospitalization.21-24 In older adults, lower extremity 
weakness is associated with poor mobility and increased fall risk.25-28 Similarly, in the Veteran 
population, every 0.10 m/s decrease in gait speed during and after an acute hospitalization is 
associated with increased self-reported disability, decreased physical health, and increased 
health-care utilization.9 These strong associations between physical function and health 
highlight the need for more intensive interventions which address mobility in older Veterans with 
HAD. Our preliminary data suggest that mobility is an important modifiable risk factor for poor 
outcomes in older Veterans with HAD that can be effectively addressed with more intensive 
rehabilitation strategies.  
 
B.3. Functional decline is associated with increased caregiver burden. 
Older Veterans are often cared for by family caregivers,29 and this assistance may be the 
difference between staying at home and the need for institutionalization. While many variables 
contribute to the degree of burden a caregiver experiences, one of the strongest predictors of 
high caregiving burden is the functional ability of the Veteran being cared for.30 A Veteran with 
low ADL function is likely to require more time and assistance with care, both factors which are 
related to higher levels of caregiver burden.31 When the burden becomes too great for a 
caregiver, there is potential for increased healthcare costs through either a need for higher 
volume of home services or eventual institutionalization. Thus, implementing the PHIT program 
has the potential to improve function and level of independence of the care recipient, while 
concurrently decreasing the burden on caregivers. Our intervention may impart long-term 
benefits on both the caregiver and Veteran care recipient by delaying or eliminating the need for 
institutionalization, or by reducing the amount of intensive support at home in the form of Home 
Based Primary Care (HBPC) services. 
 
B.4. Home health physical therapy: tremendous potential to optimize physical function.  
Home health care typically occurs during the critical time window when older adults with multiple 
comorbidities 1) are at a high risk of further health complications and 2) possess a limited 
capacity to travel to outpatient services. Unfortunately, only half of older adults report 
improvement in “walking or moving around” after receiving typical HH services.32 The reasons 

3 
 
underlying these inadequate outcomes are not fully understood. However, based on our own 
survey results, it appears that both the content and intensity of typical HH physical therapy may 
be insufficient (see Appendix). In particular, given the profound strength loss that occurs during 
hospitalization, a more intensive, multi-faceted rehabilitation approach may be necessary to 
restore patients to or beyond prior levels of functioning. Yet, no evidence exists to support the 
effectiveness of short duration, higher intensity physical rehabilitation for older adults with HAD 
in a home environment (see Significance, Section C.1). Our preliminary data strongly suggest 
the PHIT program, consisting of 1) intensive lower extremity strengthening, 2) motor control-
based intervention for gait and balance training, and 3) training in activities of daily living, can 
safely promote improved mobility in older adults following hospitalization. In this application, we 
propose to implement this PHIT intervention on a scale that will allow for more definitive 
conclusions regarding its effectiveness for improving physical function, maximizing home and 
community mobility, and reducing caregiver burden—goals which have a high potential to both 
reduce the need for formal caregiver assistance from the Veteran’s Health Administration (both 
HBPC and home health aide services) and possibly reduce the incidence of long-term 
institutionalization of older Veterans.  
 
B.5. Limitations of previous home health interventions  
There is very little research available that evaluates the effectiveness of home-based, short 
duration, high intensity rehabilitation on older adults with HAD. The studies that do describe 
home physical rehabilitation generally include low intensity interventions or are not 
generalizable to the typical population of homebound older adults after acute hospitalization. In 
addition, studies do not often measure long-term outcomes or outcomes related to community 
reintegration after hospitalization.  
 
Our research team collected data from a convenience sample of 65 home health physical 
therapists across multiple geographic locations to better understand usual care practices (see 
Appendix). The most frequently reported activities included gait training and sit-to-stand 
transfers. Even when resistance training was reported, the loads produced by elastic bands and 
cuff weights were equivalent to approximately 2 pounds. Additionally, activities promoting 
mobility were very basic with less than 10% reported performing more complex or higher level 
walking activities (e.g. non-linear walking patterns). When we asked therapists why they do not 
use more intensive rehabilitation strategies, therapists cited two main factors: 1) fear of injury to 
patients, and 2) lack of concrete evidence/guidelines for applying more intensive strategies in 
medically complex populations. The results of our therapist interviews and survey suggest the 
intensity of training and the type of activities chosen are inadequate to return patients to pre-
hospitalization levels of function. Therefore, our innovative PHIT intervention represents a novel 
change in the timing (immediately after hospitalization), frequency (shorter duration), and dose 
(high intensity) of physical therapy delivered.  
 
Summary: Rehabilitation delivered within the immediate post-hospitalization period has 
tremendous potential to mitigate HAD.3 In the current Veteran health care system, home health 
rehabilitation is extensively utilized, but it remains unclear how to maximize the impact of 
rehabilitation delivered over the short intervention periods afforded by current payment systems. 
We propose the PHIT rehabilitation program to address a key modifiable risk factor for poor 
health outcomes: impaired physical mobility.21,23,24 Rehabilitation delivered at higher intensities 
during this critical period of high medical need has the potential to improve strength and 
function. If successful in improving Veteran physical function, PHIT rehabilitation also holds 
potential for meaningful reductions in the development of disability and health care utilization. 
 
 

4 
 
 
 
Short duration, high intensity interventions targeting physical function in Veterans with HAD.  
Interventions using high intensity exercises during the immediate post-hospitalization period are 
highly innovative, because 1) older adults with HAD are commonly excluded from studies, 2) 
validation of effective short duration (4wk) rehabilitation programs during the time when patients 
are at highest risk for re-hospitalization is necessary, and 3) safe implementation of a high-
intensity rehabilitation strategy for HAD in the home setting has not been fully evaluated. 
Current standard of care almost universally includes low-intensity exercise (see Appendix). Our 
pilot data suggest that PHIT intervention delivered over 30 days not only facilitates nearly 6 
times the improvement in SPPB over UC, but also protects against sharp detraining effects 
common with low intensity interventions at 60 days post hospitalization (See Fig 2). A recent 
systematic review concluded that “no RCTs have been conducted to examine the effectiveness 
of specific reconditioning interventions in rehabilitation… [of] older adults who are 
deconditioned.”4 Indeed, many rehabilitation research studies on older adults with chronic 
diseases focus on more clinically stable cohorts,33,34 making it difficult to generalize the findings 
to homebound older adults after acute hospitalization. PHIT mobility interventions offered by 
physical therapists, at this critical juncture, have the highest chance of improving function and 
returning Veterans to meaningful participation within their homes and communities. Our study 
would provide the first large scale evidence to more definitively support future implementation 
and dissemination efforts by validating the benefits of short-duration, intensive rehabilitation 
strategies in the home setting. These benefits will be assessed in both the short term and long 
term to examine the full impact of PHIT intervention.  
 
Multi-component exercise interventions are more effective in reducing disability in older adult 
populations. From these data, we believe our PHIT intervention is highly innovative because our 
program contains greater intensity of exercise than usual care. Systematic reviews suggest that 
progressive, high intensity, multi-component exercise programs more effectively reduce 
disability in frail community dwelling older adults than single focus programs of mobility or 
strength training alone.35,36 Additionally, the Center for Disease Control recommends routine 
application of a multi-component exercise program called OTAGO for older adults at risk of falls 
and subsequent fall-related disability.37 Our progressive PHIT program is designed with a similar 
multi-component paradigm to improve function in older Veterans with HAD by addressing 1) 
loss of muscle mass with intensive strength training, 2) gait, balance, and endurance 
impairments with intensive motor control-based mobility training, and 3) ADL disability with a 
high-intensity functional training. Members of the investigative team have developed and 
published recommended treatment guidelines for this population using this multi-component 
treatment framework.3 We plan to shift current clinical practice by basing our intervention on 
scientifically valid exercise principles and packaging strength training, motor control, and ADL 
training into a concise and practical program.  
PHIT interventions targets improvements in physical function in a real world home setting. 
This paradigm-shifting proposal carries low risk to patients because the exercises are 
supervised by licensed professionals and tailored to the home environment of each person. All 
testing occurs at home rather than a laboratory setting to increase generalizability and minimize 
participant burden. Furthermore, the proposed intervention is designed to demonstrate that 
even in isolated treatment environments (e.g., home setting), more intensive treatments can be 
safely and effectively implemented. Such evidence will help counter perceptions that 
conservative intervention approaches are safer in isolated home treatment settings. 
 

5 
 
Updating practices for older Veterans with hospital-associated deconditioning is a VHA Priority:  
Our proposal is strongly aligned with the goals outlined in the Veteran’s Health Administration 
(VHA) Office of Geriatrics and Extended Care (GEC) strategic plan,38 specifically goal 1: 
Commit to Veteran-centric care, and goal 4: Continuously improve geriatric care through age-
appropriate performance indices. 
 
Goal 1: Commit to Veteran-Centric Care 
The VHA GEC has proposed a stronger focus on Veteran-centric care, which includes a focus 
on outcomes important to the Veteran population. Older Veterans have identified many barriers 
limiting their community mobility after hospital discharge; however, no protocols have been 
established to prioritize a return to community mobility in this population. Our PHIT intervention 
will examine how physical therapy influences the changes in life-space mobility after 
hospitalization, and how these changes are related to therapy dose. 
 
Goal 4: Continuously Improve Geriatric Care through Age-Appropriate Performance 
Indices 
This goal strives to identify and establish benchmarks of physical function in transitionally frail 
older Veterans. By targeting Veterans with deconditioning after an acute hospitalization, we can 
start examine what functional measures are biomarkers for adverse health event risk and 
determine which are most responsive to PHIT interventions. This will help establish functional 
benchmarks in the older Veteran population, and may contribute to additional care process 
measures in HBPC to identify and intervene upon these deficits.  
 
In addition, our proposal directly supports the Rehabilitation Research & Development Service 
(RR&D) mission statement to “advance rehabilitative care and health for our Veterans.” 
Specifically, our PHIT training program is designed to be strongly aligned with the RR&D 
mission of integrating clinical and applied rehabilitation research and translating the findings into 
clinical practice.  
 
Potential to reduce long term care costs for older Veterans in the VHA system  
The number of older Veterans is estimated to increase in the next decade, with 60% of this 
growth attributed to an increased proportion of the oldest-old (>85 years old) Veterans.8,16 Thus, 
long-term care costs within the VHA system are projected to grow substantially, especially 
among Veterans over the age of 75. Institutional nursing home services for Veterans in 
particular are estimated to rise significantly, with previous estimates as high as 22% over a 
decade.16 Use of long-term care services increases with increasing disability; thus, reducing 
ADL disability has the potential to impact utilization of costly long-term care services such as the 
use of home health aide services or VA Home Based Primary Care services. Similarly, poor 
lower extremity strength is a major predictor of institutionalization;39 thus our proposal has the 
potential to reduce the need for home and institutional long-term care services by facilitating 
greater and more sustained gains in physical function and ADL ability compared to usual care 
physical therapy.  
 
III. Preliminary Studies/Progress Report:   
 
Dr. Stevens-Lapsley (PI) (formerly Stevens, JE) has participated in the design, implementation, 
and publication of a number of clinical research studies involving a variety of patient populations 
including patients with joint arthroplasty,40,41 spinal cord injury,42 ankle fractures,43,44 and multiple 
sclerosis.45 The PI recently completed 2 RCTs in patients following total knee arthroplasty (TKA) 
(NIH R03 AR054538 and K23 AG029978) and is currently overseeing an RCT investigating the 
benefits of more intensive rehabilitation following TKA (NIH R01HD065900). These clinical trials 

6 
 
involved measurements of functional mobility that are similar to those currently proposed. 
Furthermore, the PI has spent over 3 years working with interdisciplinary teams focused on 
medically complex patients in different settings (inpatient, home health, skilled nursing facilities) 
to strengthen the proposed line of investigation. The PI also recently published a perspective 
manuscript that provides a treatment framework for rehabilitation of older adults with hospital-
associated deconditioning.3 Dr. Robert Burke (Co-Investigator) is an Academic Hospitalist and 
Director of post-acute care at the Denver VA Medical Center (VAMC). He has extensive clinical 
research expertise in transitional care for geriatric populations, which he has applied to the 
development of the current proposal. He will use his extensive network and influence with the 
providers who care for elderly patients at the Denver VA to facilitate identification and referral of 
appropriate patients to the Visiting Nurses’ Association (VNA) HH agency. Importantly, all 
medical inpatients at the Denver VAMC are seen by his hospitalist group, so he will have 
consistent access to all inpatient candidates. Dr. Bill Sullivan (Co-Investigator) is Chief of the 
Physical Medicine and Rehabilitation Service at the Denver VAMC and directs all physical 
therapy and inpatient rehabilitation services. He will facilitate patient recruitment (along with Dr. 
Burke) and referral to the VNA HH agency through coordinated oversight of his physical 
therapist staff throughout the Denver VAMC. Finally, Dr. Jeri Forster (Co-Investigator) is a 
clinical trial biostatistician who has served as the Director of the Data and Statistical Core for the 
VISN 19 Mental Illness, Research, Education and Clinical Center (MIRECC) for the last 2.5 
years, with an additional 5 years of prior collaboration. She is also an Assistant Professor in the 
Department of Physical Medicine and Rehabilitation, School of Medicine and the Department of 
Biostatistics and Informatics in the Colorado School of Public Health. She will provide expertise 
on issues related to study design, database management, quality control, data analysis, and 
preparation of manuscripts.  
D1.3. PHIT Intervention Phase I Preliminary Study 
Initial feasibility data to assess the value of the PHIT intervention and safety was performed at 
Arcadia University by Dr. Kathleen Mangione. This initial proof-of concept investigation involving 
10 patients (mean age 82 years taking > 7 medications) suggested that PHIT was both safe and 
effective compared to usual care. Moderate to large effects were found for six-minute walk 
distance (effect size; d=0.59), modified Physical Performance Test scores (effect size; d=1.37), 
fast gait speed (effect size; d=0.51), and disability score on the late life function and disability 
index LLFDI (effect size; d=2.35). The effects were significant for mPPT and LLFDI, and the 
magnitude of improvement was clinically meaningful for the six-minute walk distance (58 
meters), SPPB (1.5 points), and fast gait speed (0.2 m/sec). Dr. Mangione measured health 
care events during and for 3 months following the intervention. In the usual care group there 
were 4 total episodes in (3 re-hospitalizations, 1 emergency room visit), while the PHIT group 
had only 1 ER visit.  
 
D1.4. PHIT Intervention Phase II Preliminary Study 
The strong trends from Dr. Mangione’ s feasibility study were used to refine the program for the 
second phase of preliminary investigation in Denver, Colorado (n=18; Fig. 2) in the following 
ways 1) reduced the targeted number of PHIT physical therapy visits to target 8-10 visits over 
~30 days to more closely approximate the duration of usual care, 2) increased the complexity of 
the motor control element to challenge patients further, and 3) refined training methods for 
physical therapists providing PHIT intervention. Preliminary data from this second phase of 
investigation provide compelling evidence that a more intensive, multi-component approach to 
rehabilitation results in 1) substantially improved physical function despite short duration, 2) 
sustainability of improvements, and 3) does not increase the risk for injury (Figure 2). PHIT 
group patients received on average, 9.6 visits, while UC group received 8.3 visits. Our 
preliminary data strongly suggest that 1) PHIT intervention was far superior to UC treatment and 

7 
 
produced clinically meaningful improvements strongly supporting the importance of treatment 
strategy, and 2) the benefits of the PHIT intervention continued past the endpoint of the 
intervention suggesting sustainability (~30 days). In fact, performance in the UC group 
worsened from 30 to 60 days (after HH physical therapy), while improvements in the PHIT 
group continued after intervention (30-60 days). Furthermore, though both groups had similar 
medical complexity, the PHIT group participants had no ER visits or re-hospitalization at 90 
days, while 6 episodes (over 2 individuals) were reported in the UC group. Finally, our pilot data 
included an ethnically diverse group with 23% African American and 5% Hispanic or Latino 
participants. 
 
 
 
Clinically meaningful improvements can be summarized as follows: A one point difference in the 
SPPB represents substantial meaningful change,46 and we saw differences twice this large in 
our preliminary data. In fact, PHIT resulted in a 60% improvement in function at 60 days 
compared to only 9.7% improvement with UC. For walking speed, a 0.1m/s difference in walking 
speed represents substantial meaningful change,46 and we saw differences almost twice this 
large in our preliminary data. In fact, 30% of patients in the PHIT group achieved >1.0m/s 
walking speed (threshold for independent community ambulation)47 at 60 days; no UC group 
patients achieved this walking speed. Importantly, both groups received a comparable number 
of visits. Furthermore, these results provide evidence for the investigative team’s experience 
managing medically complex patients using the proposed intervention strategy with favorable 
outcomes. 
 
IV. Research Methods 
 
A.  Outcome Measure(s):  All measures and time points for each to be assessed are 
summarized in Table 1. Copies of each tool are attached to this application.  
 
The primary study outcome is self-selected gait speed. This measure was selected because 1) it 
has been shown to predict risk of mobility and physical disability, higher health care utilization and 
increased mortality;39,48,49 2) it has been established as a meaningful outcome measure in older 
persons with a wide range of conditions;50 3) it is a valid and reliable measure;51,52 and 4) it is 
easily performed in the home and well tolerated by patients varying in condition and degree of 
health.53 Also, in Veteran populations, improvements in gait speed after hospitalization correlate 
with reduced disability and health care costs.9 
 
Figure 2. Phase II Colorado Pilot Study outcomes for SPPB, mPPT, and 4MW (n=18). Intervention was 
complete, on average, by 31.1 days (PHIT) and 35.3 days (UC). Data reported as mean±SE.  

8 
 
Secondary Physical Function Outcomes:  
Short Physical Performance Battery (SPPB) is a well-accepted global measure of lower 
extremity function, which consists of walking speed, chair stands, and balance. It is a well-
studied composite measure and a strong predictor of disability, institutionalization, and morbidity 
in older adults (Table 3).39 The test takes ~10-15 minutes to administer. The reliability of the 
individual components, as well as the summary score of the SPPB, are good with intra class 
correlation coefficients (ICC) >0.88.54 The continuous scoring system minimizes ceiling effects 
and scores range from 0-12 with higher scores indicative of better performance.  
The modified Physical Performance Test (mPPT) assesses 7 tasks. Based on the time it 
takes to complete each task, a score from 0 (unable to complete) to 4 (performed quickly and 
easily) is given for each item. The maximum score is 28 and includes tasks that involve upper 
and lower extremity function.  
The Timed Up-And-Go (TUG) test will be performed on each participant as a measure of basic 
mobility skill and evaluation of fall risk. The TUG has excellent inter-rater reliability,55 and is 
responsive to changes in mobility status.56  
Hand-held Dynamometry (Lafayette Instrument Company, Lafayette, IN) will be used to 
objectively assess muscle performance in the lower and upper extremities. Dynamometric 
measures of quadriceps and hip strength have been used to quantify gains with resistance 
training in older adult populations, and are associated with functional performance, gait speed, 
and ADL performance. Therefore, we will assess knee extensor strength using previously 
established methodology.57 Grip strength is widely used as a measure of gross body strength. 
Home and Community Mobility Outcomes (Aim 2)                                                                                   
ActivPALphysical activity monitors (PALtechnologies, Glasgow, UK) will be used to obtain an 
objective measure of physical activity (PA). ActivPAL activity monitors assess PA using 
accelerometry, which allows objective evaluation of the relative volume (steps/day) and intensity 
(activity counts) of physical activity with high validity and reliability.58 Each participant will wear 
the ActivePAL for 5 consecutive days at all time points to assess average daily PA (steps/day). 
The ActivPAL monitor will be used only for outcome data (not intervention) and provides no 
feedback to participants.  
 
Table 1. Describing the planned study time points and assessments 
  
Table 1: Testing measures at each time point  
Outcome Measures 
 
 
Time Points 
Baseline 
  30 
days  
  60  
days 
  90 
days 
120 
days 
150 
days 
 180  
days 
Primary Outcome:   Self-selected gait 
d
X 
X 
X 
X 
 
 
X 
Other Mobility Tests:  mPPT, SPPB, 
TUG
d
t
X 
X 
X 
X 
 
 
X 
Activities of Daily Living Performance: 
NEADL
X 
X 
X 
X 
 
 
X 
Home and Community Activity 
Measures:  Life-Space Assessment,  
ActiGraph Physical Activity Monitors 
X 
X 
X 
X 
 
 
X 
Caregiver Burden: Caregiver Burden 
I
t
X 
 
X 
 
 
 
X 
Quality of Life: VR-12 
X 
 
X 
 
 
 
X 

9 
 
 
Nottingham Extended ADL Index (NEADL) will be assessed at each study time-point to 
assess Instrumental ADL performance of the participants. This measure was chosen because it 
specifically examines mobility inside and outside the home, domestic tasks, and leisure 
activities—all of which are highly important tasks when evaluating community dwelling older 
adults.59 The NEADL also has strong psychometric properties. The NEADL has predictive 
validity for health outcomes after hospitalization in many chronically ill older adult populations.60 
The test has good construct validity, and also has good test-retest reliability.59  
The Life-Space Assessment (LSA) is a self-report measure assessing a patient’s movements, 
extending from within the home to movement beyond a patient’s town or geographic region.61 
The life-space assessment is a continuous measure which can be scored from 0 (totally 
bedbound and dependent with all activity) to 120 (independent with community ambulation 
without assistance). The scores take into account both the performance of movement within and 
outside the home, the frequency of the movement, and the amount of assistance required. 
Specifically, this measure allows evaluation of actual mobility performed in the home and 
community, and can be evaluated for older adults across all levels of function. LSA has 
concurrent validity with physical function measures, as well as self-reported health and ADL 
disability.62 The Life-Space Assessment has good test-rest-reliability (ICC=0.96), and is 
responsive to change in community-dwelling older adults.61 
Quality of Life and Caregiver Burden (Aim 3)  
The Veterans RAND 12 Item Health Survey (VR-12) will be used to assess the quality of life in 
Veterans. The SF-12 has strong concurrent validity with well-established quality of life measures 
and is reliable for assessing changes in quality of life in community dwelling adults.63  
 
The Caregiver Burden Inventory (CBI) is a multi-dimensional 24-item scale with a five-point 
scoring system from 0 (never) to 4 (nearly always). The subscales of the CBI demonstrate 
strong convergent validity with caregiver depression, caregiver satisfaction, and number of 
caregiver tasks.31  
 
Adverse Events Reporting Script will be used to assess any adverse events (e.g. ER visit(s), 
hospitalization(s), major illness/injury) which occurred since the last study visit and whether the 
participant is completing their exercises.  The AE script will be administered 7 times, once at 
each of the 5 study visits, and once during each of 2 phone calls. 
 
The St. Louis University Mental Status Examination (SLUMS) screens for cognitive 
impairment by assessing participant function in the areas of attention, calculation, immediate 
and delayed recall, animal naming, abstract thinking and visuospatial skills.64 Patient 
examination with the SLUMS test is used in both clinical and research settings to screen for 
dementia. The SLUMS test has strong concurrent validity with the Mini-Mental Status 
Examination, and is a reliable screening tool for the presence of cognitive impairments with a 
reported sensitivity of 95-98% and a specificity of 76-100%.65 
 
AE Reporting Script 
X 
X 
X 
X 
Phone 
Phone 
X 
Cognition:  SLUMS 
X 
 
X 
 
 
 
X 
Patient Motivation: PAM Tool 
X 
X 
 
 
 
 
 

10 
 
The Patient Activation Measure (PAM) identifies patient motivation levels regarding their 
healthcare. The PAM tool can reliably predict future ER visits, hospital admissions, and 
medication/ therapy adherence. The survey classifies patient activation levels on a scale from 1 
(low activation/motivation) to 4 (high activation/motivation). Patients who score higher on the 
PAM survey tend to be hospitalized less and adhere to medication and therapy schedules more. 
 
 
B. Description of Population to be Enrolled:   
 
In this study, the target population is community-dwelling older Veterans or spouses of 
Veterans, 55 years of age and older, who either were hospitalized or who are medically 
deconditioned (experienced a decline in physical function) as a result of physical activity 
restrictions due to COVID-19), have several comorbid conditions, and are eligible for home 
health physical therapy. These patients will either provided with a COMIRB approved flyer 
describing the study or will be approached in the hospital and asked if they would agree to 
participate in a study examining the effects of Usual Care (UC) vs progressive high intensity 
therapy (PHIT) intervention following hospitalization.  
 
Formal inclusion/exclusion criteria are:  
 
Inclusion Criteria for Veterans/spouse of Veteran (All criteria must be met):  
1. Veteran status or spouse of Veteran 
2. 55 years of age and older 
3. Eligible for home care physical therapy 
4. Have at least 3 comorbid conditions including those listed below:  
 
o COPD  
o Gastrointestinal Bleed 
o Urinary Tract Infection 
o Pneumonia 
o Chronic ulcerative 
o Diabetes 
o Hypertension 
o Depression/mental 
o  Irritable Bowel Syndrome 
o Hernia  
o  Post-op pancreatic 
surgery 
o  Osteoporosis/OA/RA/Gout 
o Heart Disease 
o  Hypercholesterolemia 
o Peripheral Arterial 
o Spinal Stenosis 
o  Dehydration 
o Syncope 
o A fibrillation 
o  Hypo/Hyperthyroid 
o Renal Failure-no dialysis 
o Post-op bowel surgery 
o  Congestive Heart Failure 
 
 
The diagnoses most commonly reported for home health patients are diabetes, 
hypertension, heart failure, chronic ulcerative wounds, and osteoarthritis.  
  
5. Be ambulatory without human assistance prior to hospitalization and be able to maintain 
a gait speed between 0.3 m/s-1.0 m/s at baseline assessment.  Gait speed test may be 
administered in hospital to determine study eligibility. 
 
Inclusion Criteria for Caregivers: 
• 
Primary caregiver for an enrolled participant in the study 
 
Exclusion Criteria for Veterans/spouse of Veteran (one or more):  
1. Acute lower extremity fracture with weight-bearing restriction 
2. Elective joint replacement surgery 

11 
 
3. Lower extremity amputation 
4. Acute cardiac surgery 
5. Terminal illness or end stage kidney disease requiring dialysis 
6. Alzheimer's Disease 
7. Deep vein thrombosis/pulmonary embolus VT/PE 
      8.   Recent stroke      
      9.   Progressive neurodegenerative diagnosis (e.g. Parkinson’s, MS, ALS) 
     10.  Active involvement of Adult Protective Services 
     11.  Active cancer treatment in which exercise is contraindicated 
     12.  Currently enrolled in home health physical therapy upon admission to VAMC 
     13.  Clinical discretion of study physician to exclude patients who are determined to be 
unsafe and/or inappropriate to participate in high intensity rehabilitation as defined by the 
inclusion/exclusion criteria 
 
Additional exclusion assessed prior to randomization: the inability to ambulate ten feet with 
human assistance. 
 
Exclusion Criteria for Caregivers:  
• 
Being on probation or alternative prison sentencing.  
We plan to enroll 150 patients with the goal of 112 completing the study (25% drop-out rate). 
We will plan to consent up to 250 patients taking into account screening failures or hospital 
readmissions that occur prior to the first outcome visit. Enrollment in the study will be defined as 
participation in the first outcome measurement session at baseline once discharged home. The 
goal of the study is to obtain a representative sample of older adults with multiple comorbid 
conditions who receive home health physical therapy. Both sexes and all races are included in 
the study, however the Veteran population is predominantly male and Caucasian, which will be 
reflected in the enrollment.  We will also consent up to 150 Caregivers, for a total of up to 400 
consented. 
 
Study Design and Research Methods: 
 
PHIT Rationale 
The components of PHIT training as we have designed it is the currently recommended clinical 
standard by the American College of Sports Medicine for frail older adults, and are practiced by 
a small percentage of physical therapists as usual care. In fact, multiple professional 
organizations have endorsed the PHIT guidelines as the recommendations for standard of care 
for older adults. However, PHIT training is a care standard we believe is not applied consistently 
in home health by therapists because of the lack of specific data supporting superior efficacy. 
Our observations of therapists in home settings and our survey results support that 10-15% of 
therapists practice PHIT principles that are recommended as usual care (PhD student Jason 
Falvey in my lab was previously an administrator in a home health clinical setting and has 
firsthand experience observing therapists across the Denver metropolitan area as part of his 
research in my lab). The other 85-90% of therapists practice a more conservative therapy 
approach that is based on historical exercise paradigms for older adults. Thus, both paradigms 
represent a form of usual care that have not been tested against each other in this population—
a major goal of the current proposal. We have previously had IRB approvals from COMIRB for 
pilot work with testing high intensity programs that are applied less commonly but clearly within 
the auspices of usual care PT practices. These protocols have been approved without concern 
that we are engaging sites providing one of two types of usual care in research. This is similar to 
a drug trial in which two commonly used drugs are tested against each other for superior 

12 
 
efficacy; we are simply testing two usual care exercise prescriptions to definitively answer which 
one promotes superior outcomes.  
 
The PHIT program is based on sound physiological principles, relevant clinical literature, and 
our preliminary data strongly supporting the potential to improve functional mobility in the home 
setting. Multi-component exercise programs, such as the OTAGO program recommended by 
the Center for Disease Control, have been shown to be more effective in reducing and 
preventing disability in frail community dwelling older adults than single focus programs of 
mobility or strength training alone.35,36,66 The PHIT intervention will target the greatest deficits in 
older adults after hospitalization including 1) muscle weakness, 2) mobility deficits from poor 
balance and coordination, and 3) lack of independence with activities of daily living. To address 
these deficits, the 3 components of PHIT include 1) progressive intensive resistance training, 2) 
progressive motor-control program, and 3) progressive training in activities of daily living. The 
progressive, intensive resistance training for the PHIT intervention is based on ACSM 
guidelines, observation of high performing therapists, and a previous home health study by Dr. 
Mangione where she showed that leg strengthening exercise improved strength, walking 
abilities, and function one year after hip fracture compared to controls.53 Consistent with Dr. 
Mangione’s findings, a systematic review involving over 6700 participants demonstrated lower 
extremity, high intensity strength training 2-3 times per week resulted in 1) large effects for 
increasing muscle strength, 2) small effects for improving physical function, and 3) small to 
moderate effects for decreasing functional limitations.67  
 
Therefore, the second important component of the PHIT intervention is a progressive motor-
control based program that develops skill and automatic movement control by progressing 
speed and accuracy in motor tasks.68 This program has been shown to significantly improve 
self-reported mobility and gait speed, decrease the energy cost of walking, and improve self-
reported confidence in walking in community-dwelling older adults (mean age 77 years) with 
slow (≤1.0 m/sec) and irregular gait (increased gait variability).69 For frail individuals, decreasing 
energy cost is associated with improved gait speed,70,71 which could be considered a precursor 
to endurance training in these frail older adults. In this study, we will indirectly address 
endurance by targeting the energy cost of walking (gait speed).  
 
Finally, training in activities of daily living (ADLs) remains a fundamental element of all home 
therapy and represents the third, important component of the PHIT intervention. Training in 
activities of daily living emphasizes safety and compensation strategies to maximize 
independence as well as reinforce the gains made through progressive resistance exercise and 
motor control components of intervention. In general, our ADL training will be carried out as a 
task specific training program consisting of coordinated, multi-joint movement patterns that 
simulate the functional patterns required for independence in the home setting72 (i.e., transfers 
in and out of bed and sit to stands from seating surfaces within the Veteran’s home 
environment). The PHIT program will perform this task-specific ADL training at high intensity; 
each task performed will be dosed at the equivalent of an 8-10 RM resistance exercise. Task 
specific training in homebound Veterans at this intensity is likely to facilitate greater 
improvements in strength, power, and coordination in important functional patterns, and thus 
carry over to improved ADL performance.  
 
D2.1. Design Overview 
We propose to conduct a single blind, randomized controlled trial in 150 older Veterans with 
multiple chronic conditions discharged from acute care or medically deconditioned, and referred 
to home health physical therapy. The two arms will include a PHIT progressive multi-component 
physical therapy program and a documented UC physical therapy intervention. Veterans 

13 
 
admitted to the Denver VAMC will be evaluated for eligibility. Following consent, eligible patients 
be randomized to either treatment group by the home health coordinator who holds the 
randomization list. Following hospital discharge, a baseline assessment will be performed within 
48 hours of returning to their home. Follow-up assessments will occur at 30, 60, 90, and 180 
days following hospitalization (see Figure 1; specific aims).  Medically deconditioned 
participants will complete the same study visit schedule of a baseline assessment with follow-up 
visits at 30, 60, 90, and 180 days following baseline.  
D2.2. Eligibility Criteria: Patients can be included if they are Veterans or the spouse of a Veteran 
≥ 55 years of age, are eligible for home care physical therapy at the Visiting Nurses Association 
(VNA) or Berkley Home Health, have at least 3 comorbid conditions, and were ambulatory (with 
or without an assistive device) prior to hospitalization or deconditioning due to COVID-19 and 
can maintain a gait speed of 0.3 m/s-1.0 m/s at baseline assessment, which may be determined 
by a gait speed test conducted in the hospital after patient has been consented. Exclusion 
criteria include acute lower extremity fractures with weight-bearing restriction, elective joint 
replacement surgery, active cancer treatment in which exercise is contraindicated, current 
dialysis treatment, acute cardiac surgery, acute stroke, lower extremity amputation, progressive 
neurodegenerative diagnosis (e.g. Parkinson’s, MS, ALS), use of illegal substances, active 
involvement of Adult Protective Services, currently enrolled in home health physical therapy 
upon admission to VAMC or hospital, referred to hospice care, or clinical discretion of study 
physician to exclude patients who are determined to be unsafe and/or inappropriate to 
participate in high intensity rehabilitation as defined by the inclusion/exclusion criteria. 
Additional exclusion: the inability to ambulate ten feet with human assistance at the time of 
hospital discharge (see Human Subjects for more detail on inclusions/exclusions). These 
eligibility criteria are consistent with those used for preliminary data and have been successful 
with identifying patients who benefit from the proposed intervention. 
D2.3. Subject identification, recruitment, and randomization: Participants will be recruited from 
the Denver VAMC, UCHealth Highlands Ranch, and UCHealth Broomfield. Two hundred and 
fifty Veterans will be recruited (3-4 patients per month) with at least 112 expected to complete 
through the 60 day episode of care to accommodate for the potential re-hospitalization rate of 
20-30% among home care recipients32 and drop-outs for other reasons. We had no difficulty 
recruiting patients for our preliminary study (3-4 patients/month). The Denver VAMC coordinates 
home health services for approximately 300 Veterans/month. Of these, approximately 30/month 
would be eligible for this study (> 55 years old; receiving home health PT services for decreased 
mobility after an acute hospitalization; living within the Denver metropolitan area). Therefore, 
recruitment of 3-4 patients/month through the Denver VAMC alone should allow us to meet our 
recruitment goals  
Dr. Raghavan (Co-Investigator), Dr. Torberntsson (Co-Investigator), Dr. Lauren Abbate (Co-
Investigator), and Dr. Duc Ha (Co-Investigator) will identify patients at the Rocky Mountain 
Regional VAMC, Dr. William (Tom) Purcell (Co-Investigator) will identify patients at UCHealth 
Highlands Ranch, and Dr. John Updike will identify patients at UCHealth Broomfield who meet 
the inclusion criteria daily (Figure 3) as part of the direct treatment relationship and face to face 
contact with potential subjects.  A PRA under the supervision of Drs.  Raghavan, Torberntsson, 
Abbate, Ha, Purcell, and Updike will also screen medical records daily for potential research 
subjects who meet study criteria, and review verbally or by phone with the study physicians 
before approaching patients.  The PRA will ask eligible (as identified by the study CO-I 
physicians) and willing patients to sign a consent form during the hospital stay. If patients are 
identified in the hospital as eligible in a face-to-face encounter, but are discharged before they 
are consented, then a research assistant or research physical therapist will ask eligible and 
willing patients to sign the consent form in the home setting. Additionally, clinicians within the 

14 
 
Denver metro area will be informed of the study and will be provided with study flyers and with 
HIPAA A forms that they will give to their patients who meet eligibility criteria and who are 
interested in the study.  If the potential participant is interested in learning more about the study, 
but chooses not to sign the HIPAA A form, they will be provided with a flyer. If the potential 
participant is interested in learning more about the study and chooses to sign the HIPAA A form, 
they will be contacted by phone by a study team member and will be asked screening questions 
from the phone screen script.  If potential participants meet all study inclusion criteria and want 
to participate, a study team member will go to the potential participant's home and will conduct 
the informed consent process prior to baseline testing.  In either case, documentation will be 
made in the Veteran’s medical record (CPRS) indicating they have enrolled in a research study 
according to VA protocols for clinical research.  
 
After patients are consented, they will be randomized to either the PHIT treatment group or UC 
group using a randomization table that will be prepared by Dr. Jeri Forester (biostatistician) and 
held by the home health discharge coordinator at the VA who coordinates all referrals to the 
home health agency. Randomization assignments will be computer generated using random 
block sizes of 4 and 6. Randomization will occur via a centralized computer randomization 
system. 
The discharge coordinator will then refer the patient to the home health agency who is delivering 
the intervention (The Visiting Nurses Association or Berkley Home Health) and inform the 
agency of the group assignment and ensure that the appropriately trained therapist (UC or 
PHIT) is scheduled to see the patient. The PRA will then provide the patient contact information 
to a blinded outcomes assessor (physical therapist or trained research assistant) to complete 
the baseline evaluation (functional tests and questionnaires). Therapists will be told not to reveal 
or discuss their assigned protocol to other therapists. Dr. Stevens-Lapsley has successfully 
worked with the VNA to train PT staff and implement the proposed investigation for the 
preliminary data. This protocol has been followed for 22 patients recruited to-date without 
difficulty, and was successfully implemented, assessed, and the pilot data published.   
Caregivers will be approached and, if eligible and willing, consented in the home setting of an 
enrolled Veteran. A research assistant will explain the study and the goals, and ask eligible 
caregivers to participate in filling out the caregiver burden inventory after signing a HIPAA 
waiver. We will only collect and record age (categories by decade) and gender of the caregiver 
in addition to caregiver burden scores.  
D2.4. Interdisciplinary Coordination of Care: Following enrollment, Drs. Raghavan, 
Torberntsson, Purcell, Updike, Abbate, and Ha will remain involved in the interdisciplinary 
coordination of patient care as the physician contact following hospital discharge.  
D2.5. Intervention: Patients in the PHIT exercise group will receive between 10 and 12 PT visits 
in their home (45-60 min/session). Data from 3 local home health agencies indicated that the 
average number of physical therapy visits per episode of care was 8.5 (Agency 1), 7.8 (Agency 
2), and 8.6 (Agency 3). Furthermore, the average number of PT visits from the preliminary data 
for the PHIT and UC groups were 9.8 and 8.4 visits, respectively. Therefore, we chose to target 
10-12 PT visits for the proposed study to operate within a reasonable range of the current 
standards of care and maximize the benefits of the PHIT intervention. Our preliminary data 
suggest that this frequency of visits (10-12 visits over 4 weeks) will produce neuromuscular and 
physiological changes that will translate to improved function. Patients in the PHIT group will 
receive 3-4 visits per week for the first two weeks and 2 visits per week, on non-consecutive 
days for the remaining 2 weeks (total=10-12 visits). The intervention will consist of progressive 
resistance exercises for the lower extremity with a portable training device (Shuttle Mini-Press), 
a motor control-based program of gait/balance training, and ADL training—all designed to 

15 
 
improve mobility (see Table 2; Appendix). PHIT participants will also receive specific written 
nutritional education to emphasize the importance of increasing protein intake by 15 grams/day 
to support participation in the high intensity program (see Appendix).  
The patients in the UC group will also receive 10-12 visits to match the PHIT group over 4 
weeks. We will provide a standardized rehabilitation protocol for the UC group to perform over 
the 10-visit intervention period, which consists of a controlled low intensity program with 
activities from each of the domains included in the PHIT program (see Appendix). Both groups 
will also receive a standardized simple home exercise program, which will include identical 
exercise activities that differ only on intensity (See Appendix).  
Progressive High Intensity Therapy: The strength component of the PHIT intervention will be 
performed using a portable progressive resistive exercise machine that uses latex bands 
providing 6 to 100 pounds resistance (Shuttle Mini Press, Contemporary Design Company, 
Glacier, WA). The use of the shuttle press allows for standardization of treatment intensity 
across therapists while ensuring appropriate overload for high intensity strength training. The 
use of the device will not limit generalizability of study results because a number of alternatives 
for lower extremity strengthening can be easily implemented in the home setting, and previous 
research has demonstrated equal benefits for strength training using exercise bands and formal 
free weights when performed at equivalent intensities.73 The exercise intensity will be an 8-
repetition maximum, and the volume will be 3 sets of 8 repetitions. This protocol has been used 
safely and effectively in frail elders.74,75 For the first week, participants will perform 2 sets for 3 
different exercises and will increase to 3 sets for the remainder of the program. Intensity will be 
re-evaluated weekly and resistance will be increased if the participant is able to complete 8 
repetitions at the higher load using good movement form. Using the Shuttle Mini-Press will also 
allow us to estimate total training volume (weight lifted x repetitions) more precisely. We can 
then use total training volume as an explanatory variable in our analysis to determine if training 
volume explains additional variability in functional gains within the PHIT group—this will help 
provide additional evidence for efficacy of the PHIT program in deconditioned Veterans. We will 
not be collecting any data about the efficacy, feasibility, or safety of the Shuttle Press in 
promoting the strength gains specifically; we are simply using this device as one of many 
clinically appropriate modes of delivering exercise for this population (it is equivalent to using 
theraband, or free weights to deliver exercise). Thus, we do not consider use of the Shuttle 
Press as a medical device.  
 
The motor control system of PHIT mobility training begins with exercise tasks requiring low skill 
and progresses to more skilled movements as previously described.68,69 For example, the 
patient is instructed to step to a visual target placed in different positions. Stepping activities are 
performed repeatedly in one direction or to one side, then to the opposite side. As performance 
becomes skilled (i.e., accurate and smooth), then alternating stepping activities are attempted. 
Walking activities are also progressed from low skill (e.g., walking in a straight line) to more 
skilled activities such as walking in a serpentine pattern. Progression is based on increasing 
speed, accuracy, and finally with holding or manipulating of an object (dual task). Each session 
begins with practicing a “well-learned task.” Patients are progressed when performance of the 
task is 80-100% correct. As walking ability improves, this training begins to target patient 
endurance by prescribing daily walking programs for two 10 minute bouts and increasing to 20 
minutes continuous. Before discharge from home therapy, patients will begin to transition to an 
unsupervised physical activity program by performing a daily walking program and independent 
home exercises.   
 
The PHIT Activity of Daily Living (ADL) training focuses on increasing mobility in activities 
needed in daily life. Training in ADLs emphasizes safety and compensation strategies to 

16 
 
maximize independence. Activities include bathroom transfers, bed mobility (e.g. rolling, 
supine→sit), and car transfers. These activities will be delivered at higher intensities than UC as 
described above in section D.1.2. 
 
Nutritional Education Specific to PHIT Program: While all Veteran participants will receive 
nutrition screening and education at baseline, those randomized to the PHIT group will have 
ongoing nutritional education from the interdisciplinary team and be encouraged to supplement 
protein intake by at least 15g/daily to support participation in higher intensity exercise 
strategies.76,77 Written education about what foods contain at least 15g of protein will be 
provided to all PHIT group participants. Along with the rest of the interdisciplinary team, physical 
therapists will follow up on this education and document compliance each visit (see Appendix).  
 
Usual Care: UC group will undergo a standard home health evaluation, which included basic 
nutritional screening questions and education (see Appendix). The UC group will then receive 
10-12 visits of standardized UC physical therapy intervention. Agency-employed physical 
therapists will be made aware of the research study, but will not be aware of any specific goals 
or objectives to avoid contamination and maximize implementation of real world usual care 
practices. From an extensive survey of home care PTs, existing literature, and our own 
observations of home health clinical practices, we have included a standardized UC intervention 
protocol that includes representative activities such as low intensity exercise training, basic 
training in gait, balance, and transfers, ADL training, and patient education.78,79 This program 
will be matched for total rehabilitation time compared to the PHIT group; thus, exercises will 
differ only in delivered intensity.  
 
 
Other home health services:  In addition to physical therapy home health services, we 
recognize individuals may receive additional home services (e.g. nursing, occupational or 
speech therapy). We expect that the frequency of these additional services will not be different 
between groups because of randomization, but we will carefully track and report the total 
Table 2 – Brief Summary of the UC and PHIT Exercise Programs (see Appendix for more detail) 
 
Group 
Activity 
Usual Care (UC) 
PHIT 
Strength 
Training  
(40% time) 
• 3 sets x 8 repetitions: long arc quad 
(seated), hip extension (standing), 
plantar flexion (seated), hip abduction 
(seated) 
• Progress from no resistance to 0-2 lbs 
weights or low resistance bands as 
tolerated 
• 3 sets x 8 repetitions max to failure: leg 
press (supine), hip extension (standing), 
plantar flexion (standing), hip abduction 
(supine) 
• Uses Shuttle Mini-Press to standardize and 
progress resistance training each visit 
• Loads of 74-104 lbs 
Motor 
Control Gait 
Program 
(40% time) 
• Stepping Activities: forward only 
• Gait patterns: Straight line 
• Gait training: Device training, stairs, and 
outside gait until not homebound, single 
speed 
• Stepping Activities: forward, backward, 
diagonal  
• Gait patterns: straight, oval, spiral, 
serpentine   
• Gait training: obstacle course, outdoor 
surfaces, stairs/curbs, multi-speed 
 
ADL 
Training 
(20% time) 
• Bed mobility, bathroom transfers, sit to 
stands, and car transfers x 8 repetitions 
with no resistance  
• Bed mobility, bathroom transfers, sit to 
stands, and car transfers all performed at 
high intensities (8 RM maximum) 

17 
 
numbers of these additional services.  
 
D2.6. Treatment Fidelity across PHIT therapists 
Treatment fidelity is critical to the success of the proposed intervention because of the use of 
multiple physical therapists. Dr. Stevens-Lapsley has extensive experience with treatment 
fidelity for clinical trials involving rehabilitation of a multitude of patient populations. From these 
experiences, we have established mechanisms to assure the consistency of treatments across 
therapists. The availability of three PHIT-trained therapists and 3 UC therapists, covering 
different geographical areas in Denver through the Denver Visiting Nurses Association and 
Berkley Home Health will allow us to enroll all eligible patients, regardless of location. Dr. 
Stevens-Lapsley, and the research physical therapists (Jason Falvey, PT and Allison Kosir, PT) 
will provide 2-3 initial training sessions to therapists providing UC and PHIT interventions to 
review treatment protocols and documentation.  
 
A manual will be provided to each clinician with protocol details, clinic and home exercise 
pictures, documentation forms, and study contact information. Research Physical Therapists will 
review the intervention data sheets biweekly, and will conduct monthly phone meetings with the 
PHIT and UC physical therapists. If the treatment fidelity is below 90%, additional training 
sessions will be scheduled with individual therapists. Treatment fidelity data will provide 
information on the adherence of the PT to the interventions, the adherence of the participants to 
the prescribed activities, and will provide an opportunity to address potential study problems 
(see Appendix). In addition, every month for the first year, and every three months thereafter, 
treating therapists will meet to discuss treatment guidelines and any issues that have surfaced. 
For each agency therapist, the research physical therapists will observe 4-5 home sessions for 
the first 2 patients. These on-site observations may be supplemented with video conferencing 
during treatment sessions for additional oversight as necessary. Should new therapists require 
training during the course of the investigation, the same procedures for initial training and 
monitoring will be implemented. Each treating therapist will fax documentation weekly to ensure 
protocols are being followed. 
 
Blinding of Research Staff: Only the research physical therapists conducting staff training, and 
the VNA HH or Berkley Home Health agency manager will have full knowledge of group 
assignment. Outcome data will be assessed by Physical Therapist Outcomes Assessors who 
will remain blinded to treatment group. Intervention PTs will only provide either PHIT or UC 
intervention. Patients will be instructed not to discuss what they do during their home physical 
therapy sessions with the Physical Therapist Outcomes Assessor to maintain blinding, and also 
be asked to not share the group assignments during any care coordination meetings.  
 
C. Description, Risks and Justification of Procedures and Data Collection Tools: 
 
All assessments and interventions in this study are considered to be a part of physical therapist 
clinical practice. We see little or no additional risk resulting from participation in this study. To 
minimize risk of falls and injury, the PHIT training protocol will be conducted with licensed 
physical therapists (PTs) trained to minimize risk of falls and will not be undertaken in subjects 
who report inability to perform the tasks. In all conditions of outcome testing in which the 
participant is standing and/or walking (e.g. conditions with a potential risk for falling), the 
participant will be directly supervised by a member of the research staff (PRA or research 
physical therapist) who has been trained on all measures by a physical therapist, and a licensed 
physical therapist will be available by telecommunication at all times.  
 

18 
 
There is no expectation that the proposed multi-component intervention will evoke serious 
cardiovascular responses. Gardner et al80 reviewed controlled clinical trials with exercise 
interventions for older adults at-risk for falling. No cardiac events or falls were reported in the 12 
clinical trials reviewed. No significant cardiac events were reported after performing one 
repetition maximum (1-RM) testing for over 6600 healthy subjects.81 A recent review of 12 
articles examining the safety of high intensity resistance training and testing in persons with 
coronary disease found an absence of anginal symptoms, ischemic ST-segment depression, 
abnormal hemodynamics, complex ventricular dysrhythmias, and cardiovascular 
complications.82 Less serious risks may include chest pain, fainting, hypotension, or muscle 
strain.  
 
We have minimized risk to patients who are not undergoing exercise stress tests by following 
the guidelines suggested by Gill et al. which are outlined below.83 Every effort will be made to 
prevent adverse events including stopping exercise when the patient reports shortness of 
breath, angina or dizziness. A licensed physical therapist will supervise all of the training 
sessions and will additionally monitor blood pressure at the start of the training session, mid-
session, and when participants are finished with the session. Blood pressure and heart rate will 
be monitored using a standard blood pressure cuff and palpation of peripheral pulse. If blood 
pressure is elevated above 160/100, the participant will rest quietly for a few minutes. The PT 
will monitor the patient for signs of muscle strain, dizziness, or hypotension. As needed, 
appropriate palliative methods will be discussed with the participants and reported to the 
primary care physician, although these adverse events are also not expected. All PTs and PRAs 
will be trained in a standardized way to address all safety precautions.  
 
Delayed onset muscle soreness is a common occurrence after the initiation of an exercise 
program. The soreness occurs in the muscle belly 1-3 days after the initiation of exercise and 
lasts 2-3 days. There is no effective way to eliminate the risk of delayed onset muscle soreness, 
but it is hoped that the orientation process and gradual increase in intensity will reduce the risk. 
The participants will be informed about the condition, what it feels like, how long it lasts, and 
suggested ways of decreasing the pain including the use of superficial heat or ice.  
 
There is also a small risk of rash on the area of skin on which the TegaDerm patch is applied.  
We anticipate that these risks are minimal, and have low potential for any long-term harm. 
Nonetheless, if any abnormal skin reactions are observed, we will notify either the home health 
agency nursing staff, the patient’s physician, or a study physician to determine the appropriate 
medical care.  
 
Other outcome assessments are also expected to be minimal risk to participants. Use of 
ActiGraph monitors to assess physical activity is common in older adult populations, and has 
not been associated with adverse events of a serious nature. Physical therapists treating 
patients will monitor for skin irritation over the areas where the Actigraph straps come into 
contact with skin and discontinue use if any skin breakdown occurs.  
 
We have established the following apriori stopping criteria for removing a Veteran from the 
study to maintain the safety of the participant.  
 
Participants will be withdrawn from the study by the investigators if: 
 
a.) They are admitted to the hospital after enrollment and the study physician determines the 
Veteran unsafe or inappropriate for high intensity rehabilitation as defined by the 
inclusion/exclusion criteria 

19 
 
b.) They develop a new medical or psychiatric condition after enrollment which precludes 
participation in exercise training based on ACSM criteria or the determination of a physician, 
safety officer, or investigator (i.e. new cardiac diagnosis such as unstable angina, marked 
change in cognition, acute illness, pneumonia) 
 
Expected Adverse and Serious Adverse Events: 
The following are expected AEs and SAEs for this study:  High risk behavior, e.g. drug use 
and/or alcohol abuse; hospitalizations due to poor functional mobility, e.g. falls; and 
complication from or exacerbation of current medical diagnoses and comorbidities. 
 
Data Management Risks:  As with any study, there is a risk of data breach or disclosure of study 
data outside the study team (e.g through accidental loss of data, theft, inadvertent electronic or 
paper disclosures). We will minimize these risks through the following protocol for collecting 
data:  
 
1.) Medical data relevant to the study (hospital length of stay, comorbidities, age, sex, etc) 
will be extracted from the VA EMR and recorded for each patient in the VA version of 
RedCap by a member of the investigative team.  The VA Informatics and Computing 
Infrastructure (VINCI) will be used as a central location for data processing and 
management. Vanderbilt University, with collaboration from a consortium of institutional 
partners, has developed a software toolset and workflow methodology for electronic 
collection and management of research and clinical trial data. REDCap (Research 
Electronic Data Capture) data collection projects rely on a thorough study-specific data 
dictionary defined in an iterative self-documenting process. REDCap servers are housed 
at the VA Informatics and Computing Infrastructure (VINCI). VINCI servers are physically 
located at the VA Austin Information Technology Center (AITC), located in Austin, 
Texas. REDCap was developed specifically around HIPAA-Security guidelines. REDCap 
has been disseminated for use locally at other institutions and currently supports 240+ 
academic/non-profit consortium partners on six continents and over 26,000 research 
end-users (www.project-redcap.org). All EMR access will occur behind the VA firewall, 
and directly input into RedCap, thus minimizing the risk of accidental disclosure outside 
the VA and maintaining strict access only to VA employees. RedCAP access will only be 
granted to PRAs in a data entry capacity only, and other investigators will only be 
granted access consistent with their duties in database management or data checking. 
Computer access will occur either at VA buildings, or using a VA computer set up in the 
lab space of Dr. Jennifer Stevens-Lapsley on the University of Colorado Campus in 
Room EG308 in Building 500.  
 
2.) All paper documents generated (e.g. consent forms, outcome measures collected in the 
home setting, HIPPA B forms) will be transported between patient homes and different 
VA sites (downtown 9th Street hospital, Clinical Building South, Fitzsimons Building) only 
using lockable bags that are approved by the VA. These documents will be stored in a 
locked cabinet, within a locked office in the RSC (Rehabilitation Science Consortium) in 
the Fitzsimons Building. These documents will be also scanned directly into a VA 
computer and stored electronically on a VA server to be accessed electronically with 
minimal transportation of sensitive data.  

20 
 
 
 
D. Potential Scientific Problems:   
Missing Data. All patients with outcome measurements will be included in the intent-to-treat 
analysis. Although we will encourage patients to be fully compliant to their assigned treatment 
regimen and testing sessions, they will not be dropped from follow-up measurements for lack of 
compliance. Although statistical methods can be used to “adjust” for missing data, these 
methods rely on the untestable assumption that data are “missing at random” so that the effect 
of the missingness can be removed through statistical modeling. We will instead focus on 
preventing missed follow-up visits and evaluate missingness to determine whether the data are 
consistent with the hypothesis of missing at random or missing completely at random. 
 
F.   Data Analysis Plan:   
 
Primary and Secondary Outcomes: The primary outcome for this study is gait speed 
measured 60 days following hospital discharge. Secondary outcome measures include SPPB 
measured at other study time points, mPPT, LSA, NEADL, VR-12, and CBI, measured at 
designated study time points (see Table 3). The 60 day time point is chosen for clinical 
relevance because it helps establish not only efficacy but also sustainability of the effects after 
the initial 30-day intervention period. Preliminary descriptive and graphical analyses (including 
boxplots, scatterplots, profile plots) will be used for data cleaning and visualization.  
Primary Analysis (Aim 1): The primary analysis will be an intent-to-treat comparison of the 
differences between treatment groups in change in gait speed 60 days following hospital 
discharge. Statistical inference regarding the difference between treatment groups will be based 
on the estimated coefficient for a treatment group indicator variable in a linear regression model 
with 60 day change in walking speed as the response variable, and explanatory variables that 
include an indicator of treatment group and the baseline value of gait speed. The baseline gait 
speed value is included to improve the precision/power of the inference about treatment 
differences. The conclusion about the statistical significance of differences between groups will 
be determined by this single statistical test to protect against an elevated risk of false-positive 
conclusions. Sensitivity analysis will be done to evaluate whether conclusions would differ when 
other important covariates are added to the model (length of hospital stay, inflammatory 
molecules, presence of the frailty phenotype [Fried’s criteria84], days of intensive care unit stay, 
days of inpatient rehabilitation, age, comorbidity burden, social status, gender]. These variables 
will be extracted from the VA EMR and stored in the VA version of RedCAP using unique ID 
numbers for each Veteran. Secondary Analyses (Aim 2): Differences between groups at 60 
days following hospital discharge in other outcomes (SPPB, mPPT, PA, dynamometry, LSA, 
PAM NEADL, CBI, SLUMS, and VR-12) will be analyzed as described above. Follow-up 
measures at 90 and 180 days will be analyzed to evaluate the long-term impact and 
sustainability of our PHIT interventions. Secondary analyses will be evaluated for their 
consistency with the conclusions of the primary endpoints. We anticipate that group differences 
in secondary measures will be correlated with the primary so that significant differences in the 
primary endpoint will be reinforced by similar effects on secondary endpoints. Failure to observe 
consistency in the primary and secondary endpoints will be taken as evidence that the effects of 
PHIT are not clear, and that further study is necessary to resolve any inconsistencies. This 
approach will reduce the risk of false-positive conclusions resulting from multiple statistical tests.  
The characteristics of the time trajectory (30, 60, 90 and 180 days of follow-up) for treatment 
effects will also be analyzed in secondary analyses to elucidate the mechanism and inform the 

21 
 
development of methods to improve long-term outcomes. The analytic methods will include 
maximum likelihood estimates from a repeated measures model of the mean effect at each of 
the measurement times.85 The trend in means will be evaluated using a linear contrast as the 
summary measure of greatest interest.86 This approach will evaluate whether there are 
differences in the first-order trends (slope) between intervention groups. Finally, we will estimate 
adverse events rates (falls, emergency department visits, nursing home days, or re-
hospitalizations) for each arm and compare rates between arms using a likelihood ratio test. We 
will additionally investigate whether training volume significantly explained additional variability 
in functional gains within the PHIT group using regression analysis.  
Sample Size Estimates 
Statistical power was estimated based on the results of a pilot study of 18 participants: 8 were 
randomized to PHIT, 10 to the UC interventions (results for SPPB, gait speed, and mPPT are 
shown in Figure 2). We observed a between group difference ± SD in gait speed of 0.18 ± 0.29 
meters/second (m/s) in the preliminary study. Thus, a sample size of 112 patients completing 
the study (56/group) will provide 90% power (assuming the same pooled SD in both groups to 
be conservative) to detect differences at least that great. This represents 1.8 times a clinically 
important difference of 0.1m/s.46 This estimate is conditional upon using a 2-sided, alpha = 0.05 
level 2-group t-test.  
We expect that we will consent 250 Veterans and spouses for the study, with 
allowance for a 25% screening failure. Screening failures that occur after consent is 
obtained and before enrollment in the study may include a change in medical status 
during hospitalization requiring a discharge to a location other than home health 
(e.g skilled nursing facility) , a hospital re-admission which occurs after hospital 
discharge but prior to the baseline assessment being completed, or a failure to 
meet specific performance inclusion criteria (e.g. a Veteran or spouse who lacks the 
ability to ambulate 10 feet without at least minimal physical assistance [more than 
supervision or light touching for steadiness] from another person) 
 
Enrollment in the study will be defined as participating in the baseline functional performance 
measures. We expect to enroll 150 Veterans and spouses into the study, with 112 needed to 
complete to meet study goals. From our experiences and available data, we anticipate a 25% 
drop out. Caregivers will be consented after a Veteran or spouse is enrolled in the study, thus 
we anticipate enrolling 150 caregivers. Caregivers will undergo assessment of caregiver burden 
on the outcome measurement schedule above until the conclusion of the 180 day study period, 
or until the Veteran or spouse for whom they give care is lost to the study (e.g re-hospitalized)—
similarly, we anticipate to need 112 to complete.  
 
Thus, in total, we anticipate consenting 250 Veterans and spouses for the study, enrolling 150 
of them, and expecting 112 to complete. We will additionally be consenting 150 caregivers with 
112 expecting to complete. For the total study, we will be consenting 400 participants (250 
Veterans and spouses, 150 caregivers) and expecting 224 to complete (112 Veterans and 
spouses, 112 Caregivers). These numbers have been provided to as part of the grant 
application process to the Veterans Administration Rehabilitation Research and Development 
Service and were favorably reviewed and pending a funding announcement for a Merit Award 
(R01 equivalent). 
 
  G.  Summarize Knowledge to be Gained:   
There is a growing recognition that acute hospitalization contributes to long-term disability for 
hospitalized older adults—who are 60 times more likely to develop disability than those who 
are not hospitalized. Older Veterans are particularly vulnerable to functional decline after 

22 
 
hospitalization, as this population has lower function and more comorbidities than age-matched 
peers.  Home Health (HH) physical therapy may be the ideal venue for addressing these 
mobility deficits. However, as currently structured, these services do not appear to adequately 
address deconditioning often resulting from acute hospitalization as evidenced by poor 
functional recovery, and poor community and home mobility, up to 2 years after acute 
hospitalization. A more intensive approach to HH physical therapy delivered within the 
immediate post-hospitalization period in older Veterans has great potential to maximize 
physical function, home and community mobility, and quality of life. Therefore, we have 
developed a short duration, progressive high intensity therapy (PHIT) intervention that directly 
addresses the functional deficits seen after acute hospitalization. If successful in improving 
patient function, PHIT intervention holds potential for future health care cost savings by 
reductions in the need for formal caregiving services and institutionalization in the older 
Veteran population.   
 
 
 
 
 
 
 
 
 
 
 
 
 
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