Status:
COMPLETED
Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborating Sponsors:
Dairy Research Institute
National Dairy Council
Conditions:
Aging
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief 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.
Detailed Description
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT02203656
Start Date
October 1 2013
End Date
December 1 2017
Last Update
April 4 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
UTMB Acute Care for Elders Unit
Galveston, Texas, United States, 77550
2
Jennie Sealy Hospital
Galveston, Texas, United States, 77555