Aging
Conditions
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.
Interventions
DRUGTestosterone
DIETARY_SUPPLEMENTProtein Supplement
OTHERPlacebo Injection
OTHERPlacebo supplement
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Performance | Change from Baseline to 30-day Followup | Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip Strength | Change from Baseline to 30-day Followup | strength by handheld dynamometer, kg |
| Physical Activity Level | Change from Baseline to 30-day Followup | Number of daily steps |
| 30 day re-admission | 30 days post-discharge | Readmission within 30 days of hospital discharge |
Countries
United States
Outcome results
None listed