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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Dairy Research Institute; National Dairy Council
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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