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

Completed · Phase 1 · Has a placebo group

Conditions studied: Aging

In brief

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.

Key facts

Study ID

NCT02203656

Run by

The University of Texas Medical Branch, Galveston

People needed

113

Starts

2013-10-01

Expected to finish

2017-12-01

Last updated by the study team

2019-04-04

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UTMB Acute Care for Elders Unit — Galveston, Texas, United States
• Jennie Sealy Hospital — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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