Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults

Study Overview
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Brief Summary
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The purpose of this study is to test the feasibility of interventions to accelerate recovery of muscle mass and function in older adults following acute hospitalization.

Detailed Description
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The purpose of this study is to test the feasibility of interventions to accelerate recovery of muscle mass and function in older adults following acute hospitalization

Official Title
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Feasibility Study of Post-hospitalization Interventions to Improve Physical Function

Conditions
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Aging

Intervention / Treatment
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* Drug: Placebo
* Dietary Supplement: Nutritional Supplement
* Behavioral: In-home exercise
* Drug: Testosterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to the University of Texas Medical Branch (UTMB) ACE unit with an admitting diagnosis of congestive heart failure, respiratory infection, kidney/urinary tract infection, or metabolic disorder; or other condition that will allow a subject to participate in the study after patient review Aged 65 years or older Self-reported ability (with or without the aid of an assistive device) to walk across a small room two weeks prior to hospitalization Lives within 30 miles of UTMB Can stand without assistance at the time of pretesting Presents no medical contraindication to wearing a loose fitting velcro strap for the accelerometer on one ankle Score ≥26 on the 30-item Mini Mental State Examination or alert and oriented X3 by physician on H&P Is discharged to home at ACE unit discharge. Exclusion Criteria: Nursing home resident or hospice patient Uncontrolled blood pressure (systolic >150, or diastolic > 100) History of stroke with motor disability Glomerular filtration rate (GFR) <30 mL/min/1.73m2 or evidence of kidney disease or failure Liver disease ( aspartate aminotransferase (AST) /Alanine transaminase (ALT) 2 times above the normal limit, hyperbilirubinemia) Recent (within 3 months) treatment with anabolic steroids Any other condition or event considered exclusionary by the PI and faculty physician Planned or elective hospitalization within 30 days of discharge Additional Exclusion Criteria for Subjects Randomized to the Testosterone Group Breast or prostate cancer Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml PSA ≥ 3 ng/ml in men at high risk of prostate cancer, such as African Americans or men with first-degree relatives with prostate cancer Hematocrit ≥ 50% Decompensated heart failure as determined by a physician

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Supplement<br>Daily placebo supplement for 30 days after discharge. | Drug: Placebo<br>* placebo supplement<br>* Other names: Control;|
| Experimental: Nutritional Supplement<br>Daily nutritional supplement for 30 days after discharge. | Dietary Supplement: Nutritional Supplement<br>* protein supplement<br>|
| Experimental: In-home exercise + placebo<br>in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge. | Drug: Placebo<br>* placebo supplement<br>* Other names: Control;Behavioral: In-home exercise<br>* In-home exercise program<br>|
| Experimental: In-home exercise + nutrition<br>in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge. | Dietary Supplement: Nutritional Supplement<br>* protein supplement<br>Behavioral: In-home exercise<br>* In-home exercise program<br>|
| Experimental: Testosterone<br>Single testosterone injection within 24 hours of hospital discharge. | Drug: Testosterone<br>* Testosterone injection<br>* Other names: Testosterone enanthate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score | Changes in SPPB score | at pre-testing, 1-week post discharge and 4-week post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition | Body composition will be measured using a bioimpedance scale. Changes in weight and % body fat will be calculated over the duration of the intervention. | at pre-testing, 1-week post discharge and 4-week post discharge | 
| Hand grip strength (kg) | Changes in hand grip will be calculated over duration of study. | at pre-testing, 1-week post discharge and 4-week post discharge | 
| ADLS, IADLS | Changes in Instrumental activities of daily living (IADLS), and Activities of daily living (ADLS) will be measured over the duration of the intervention. | at pre-testing, 1-week post discharge and 4-week post discharge | 
| Physical Activity Levels | Physical activity levels will be measured using a step activity monitor and actiwatch | at pre-testing, 1-week post discharge and 4-week post discharge | 
| Gait Speed (m/s) | Changes in gait speed will be calculated over duration of study. | at pre-testing, 1-week post discharge and 4-week post discharge | 
| Blood Measures | microRNA levels in blood will be measured | at pre-testing, 1-week post discharge and 4-week post discharge | 
| 30 day re-hospitalization | re-hospitalization rates will be collected | 30 days post-discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intervention studies, nutrition, exercise, testosterone, patient readmission