Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients
Purpose
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.
Condition
- Aging
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator Placebo |
Placebo Supplement Placebo Injection |
|
Experimental Testosterone |
Placebo Supplement Testosterone Injection |
|
Experimental Protein Supplement |
Protein Supplement Placebo Injection |
|
Experimental Protein Supplement + Testosterone |
Protein Supplement Testosterone Injection |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- The University of Texas Medical Branch, Galveston
Study Contact
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.