Improving Function in Older Veterans With Hospital-Associated Deconditioning

Study Overview
=================
Brief Summary
-----------------
The investigators plan to test an innovative, home-based, short duration, high intensity exercise program designed for application in the immediate post-hospitalization period in older Veterans. Preliminary data suggest a more intensive approach to physical therapy in older adults after hospitalization is safe and maximizes mobility more than usual care. The Veterans participating in the high intensity exercise program will receive therapy utilizing higher resistance exercises. Outcomes from this group will be compared to data collected from the patients receiving standard, lower resistance therapies.

Detailed Description
-----------------
Hospital associated deconditioning is a common and profound contributor to functional decline in older adults. Skeletal muscle weakness and atrophy are commonly observed in older adults with deconditioning after a hospitalizations, leading to chronic functional deficits. This is especially concerning for elderly Veterans, a population who tends to suffer from more chronic conditions and have decreased physical function than the general older adult population. Therefore, Veterans may be at even higher risk for developing disability in activities of daily living after hospitalization and be homebound. Home health physical therapy may be the ideal venue for addressing this functional decline as around 3 million older adults receive home health services following hospital discharge. These services, however, tend to be low intensity and do not appear to adequately address deficits in function or performance of home and community mobility. To address these concerns, the investigators have developed and tested an innovative, short-duration, home-based, high intensity exercise program designed for application immediately following hospitalization. This protocol will dose twelve therapy visits over the course of 30 days to determine whether visit frontloading has any effect on outcomes. The investigators are using a series of high resistance therapy exercises following acute hospitalization to determine if progressive high intensity therapy sustainability improves physical function more than standard home health physical therapy after an acute hospitalization in older Veterans. Outcomes will spotlight physical function, community mobility, Activities of Daily Living, quality of life, and cognition.

Official Title
-----------------
Improving Function in Older Veterans With Hospital-associated Deconditioning

Conditions
-----------------
Frail Elderly, Homebound Persons

Intervention / Treatment
-----------------
* Behavioral: Progressive High Intensity Therapy (PHIT)
* Behavioral: Usual Care (UC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent hospitalization or period of deconditioning Veteran Status Referred to or eligible for home health physical therapy Have at least 3 comorbid conditions including: Chronic Obstructive Pulmonary Disease (COPD), pneumonia, hypertension, hernia, heart disease, spinal stenosis, atrial fibrillation, post-op bowel surgery, gastrointestinal bleed, chronic ulcerative wounds, depression/ mental health, post-op pancreatic surgery, hypercholesterolemia, dehydration, hypo/hyperthyroid, congestive heart failure, urinary tract infection, diabetes, irritable bowel syndrome, osteoporosis, osteoarthritis, rheumatoid arthritis, gout, peripheral artery disease, syncope, renal failure-no dialysis Be ambulatory without human assistance prior to hospitalization Exclusion Criteria: Acute lower extremity fracture with weight-bearing restriction Elective joint replacement surgery Lower extremity amputation Acute cardiac surgery Terminal illness Cancer Alzheimer's disease Deep vein thrombosis Recent stroke Degenerative neurological conditions Gait speed slower than 0.3 m/s or >1.0 meters/second Inability to walk 10 feet without human assistance --History of illegal substance use

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care (UC)<br>Participants in the Usual Care (UC) group will receive standard, low-intensity physical therapy following discharge from acute hospitalization. | Behavioral: Usual Care (UC)<br>* Participants in the Usual Care group will receive standard physical therapy following discharge from acute hospitalization. The activities of therapy will include basic strength training, single-planar motor control and gait exercises, and activities of daily living training. Participants will receive 12 intervention visits over 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program.<br>|
| Experimental: Progressive High Intensity Therapy<br>Participants in the Progressive High Intensity Therapy (PHIT) group will receive high intensity physical therapy following discharge from acute hospitalization. | Behavioral: Progressive High Intensity Therapy (PHIT)<br>* Participants in the Progressive High Intensity Therapy (PHIT) group will receive high intensity physical therapy following discharge from acute hospitalization. The activities of training will include progressive resistance training, multi-planar motor control and gait exercises, and high intensity activities of daily living training. Like the Usual Care group, the PHIT participants will receive 12 intervention visits over 4 weeks (3 visits per week). Participants will also receive a standardized home exercise program.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Selected Walking Speed | Will be assessed at the subject's self selected speed for each participant over 4 meters. Fastest walking assesses capacity for performance of certain activities (e.g. crossing a street before the light changes). | 60 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery (SPPB) | 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. | 180 Days | 
| Short Physical Performance Battery (SPPB) | 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. | Baseline | 
| Short Physical Performance Battery (SPPB) | 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. | 30 Days | 
| Short Physical Performance Battery (SPPB) | 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. | 60 Days | 
| Short Physical Performance Battery (SPPB) | 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. | 90 Days | 
| Timed-Up-And-Go Test | The TUG measures the time it takes a patient to rise from an arm chair (seat height of 46 cm), walk 3 m, turn and return to sitting in the same chair without physical assistance.25 This test has excellent inter-rater (ICC=0.99) and intra-rater reliability (ICC=0.99), as measured in a group of 60 functionally disabled older adults (mean age 80 years). | Baseline | 
| Timed-Up-And-Go Test | The TUG measures the time it takes a patient to rise from an arm chair (seat height of 46 cm), walk 3 m, turn and return to sitting in the same chair without physical assistance.25 This test has excellent inter-rater (ICC=0.99) and intra-rater reliability (ICC=0.99), as measured in a group of 60 functionally disabled older adults (mean age 80 years). | 30 Days | 
| Timed-Up-And-Go Test | The TUG measures the time it takes a patient to rise from an arm chair (seat height of 46 cm), walk 3 m, turn and return to sitting in the same chair without physical assistance.25 This test has excellent inter-rater (ICC=0.99) and intra-rater reliability (ICC=0.99), as measured in a group of 60 functionally disabled older adults (mean age 80 years). | 60 Days | 
| Timed-Up-And-Go Test | The TUG measures the time it takes a patient to rise from an arm chair (seat height of 46 cm), walk 3 m, turn and return to sitting in the same chair without physical assistance.25 This test has excellent inter-rater (ICC=0.99) and intra-rater reliability (ICC=0.99), as measured in a group of 60 functionally disabled older adults (mean age 80 years). | 90 Days | 
| Timed-Up-And-Go Test | The TUG measures the time it takes a patient to rise from an arm chair (seat height of 46 cm), walk 3 m, turn and return to sitting in the same chair without physical assistance.25 This test has excellent inter-rater (ICC=0.99) and intra-rater reliability (ICC=0.99), as measured in a group of 60 functionally disabled older adults (mean age 80 years). | 180 Days | 
| modified Physical Performance Test (mPPT) | 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 maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders | Baseline | 
| modified Physical Performance Test (mPPT) | 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 maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders | 30 Days | 
| modified Physical Performance Test (mPPT) | 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 maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders | 60 Days | 
| modified Physical Performance Test (mPPT) | 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 maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders | 90 Days | 
| modified Physical Performance Test (mPPT) | 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 maximal score is 28 and includes tasks that involve upper and lower extremity function. Test-retest reliability for the modified PPT score is 0.96. The instrument is sensitive to change and has been used in exercise trials with frail elders | 180 Days | 
| Lower Extremity Hand-Held Dynamometry | knee extensor strength | Baseline | 
| Lower Extremity Hand-Held Dynamometry | knee extensor strength | 30 Days | 
| Lower Extremity Hand-Held Dynamometry | knee extensor strength | 60 Days | 
| Lower Extremity Hand-Held Dynamometry | knee extensor strength | 90 Days | 
| Lower Extremity Hand-Held Dynamometry | knee extensor strength | 180 Days | 
| Grip Strength Dynamometer | Grip Strength | Baseline | 
| Grip Strength Dynamometer | Grip Strength | 30 Days | 
| Grip Strength Dynamometer | Grip Strength | 60 Days | 
| Grip Strength Dynamometer | Grip Strength | 90 Days | 
| Grip Strength Dynamometer | Grip Strength | 180 Days | 
| Self Selected Walking Speed | Will be assessed at the subject's self selected speed for each participant over 4 meters. Fastest walking assesses capacity for performance of certain activities (e.g. crossing a street before the light changes). | Baseline | 
| Self Selected Walking Speed | Will be assessed at the subject's self selected speed for each participant over 4 meters. Fastest walking assesses capacity for performance of certain activities (e.g. crossing a street before the light changes). | 30 Days | 
| Self Selected Walking Speed | Will be assessed at the subject's self selected speed for each participant over 4 meters. Fastest walking assesses capacity for performance of certain activities (e.g. crossing a street before the light changes). | 90 Days | 
| Self Selected Walking Speed | Will be assessed at the subject's self selected speed for each participant over 4 meters. Fastest walking assesses capacity for performance of certain activities (e.g. crossing a street before the light changes). | 180 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Veterans, Progressive High Intensity Physical Therapy, Gait Speed, Acute Hospitalization, Hospital Associated Deconditioning