Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients

Study Overview
=================
Brief Summary
-----------------
The goal of this pilot study is to collect preliminary data on the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Detailed Description
-----------------
The purpose of this pilot study is to test the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Official Title
-----------------
Translating Muscle Anabolic Strategies Into Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Drug: Testosterone
* Dietary Supplement: Protein Supplement
* Other: Placebo Injection
* Other: Placebo supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to the UTMB hospital 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 Alert and oriented x3 by a physician on H&P. Discharged to home at hospital discharge. Participation in the study will be terminated in those subjects not discharged to home after hospital stay. Exclusion Criteria: A Nursing home resident or hospice care patient Uncontrolled blood pressure (systolic >170, or diastolic > 100) New onset motor disability that prevents walking at the time of baseline testing (stroke with motor disability, lower limb orthopedic dx) End stage renal disease AST/ALT 2.5 times above the normal limit Recent (within 3 months) or current treatment with anabolic steroids. History of 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) Hematocrit ≥ 50% Any other condition or event considered exclusionary by the PI and faculty physician

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo Supplement Placebo Injection | Other: Placebo Injection<br> <br> * Other names: saline;Other: Placebo supplement<br> <br> * Other names: maltodextrin;|
| Experimental: Testosterone<br>Placebo Supplement Testosterone Injection | Drug: Testosterone<br> <br> * Other names: testosterone enanthate;Other: Placebo supplement<br> <br> * Other names: maltodextrin;|
| Experimental: Protein Supplement<br>Protein Supplement Placebo Injection | Dietary Supplement: Protein Supplement<br> <br> * Other names: whey protein;Other: Placebo Injection<br> <br> * Other names: saline;|
| Experimental: Protein Supplement + Testosterone<br>Protein Supplement Testosterone Injection | Drug: Testosterone<br> <br> * Other names: testosterone enanthate;Dietary Supplement: Protein Supplement<br> <br> * Other names: whey protein;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Performance | Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance | Change from Baseline to 30-day Followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip Strength | strength by handheld dynamometer, kg | Change from Baseline to 30-day Followup | 
| Physical Activity Level | Number of daily steps | Change from Baseline to 30-day Followup | 
| 30 day re-admission | Readmission within 30 days of hospital discharge | 30 days post-discharge |