Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT02203656
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02203656
Study Brief:
Protocol Section:
NCT02203656