Feasibility Study of Post-hospitalization Interventions to Improve Physical Function
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Aging
- Sponsor
- The University of Texas Medical Branch, Galveston
- Enrollment
- 113
- Locations
- 2
- Primary Endpoint
- Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
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
Arms & Interventions
Placebo Supplement
Daily placebo supplement for 30 days after discharge.
Intervention: Placebo
Nutritional Supplement
Daily nutritional supplement for 30 days after discharge.
Intervention: Nutritional Supplement
In-home exercise + placebo
in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.
Intervention: Placebo
In-home exercise + placebo
in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.
Intervention: In-home exercise
In-home exercise + nutrition
in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.
Intervention: Nutritional Supplement
In-home exercise + nutrition
in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.
Intervention: In-home exercise
Testosterone
Single testosterone injection within 24 hours of hospital discharge.
Intervention: Testosterone
Outcomes
Primary Outcomes
Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score
Time Frame: at pre-testing, 1-week post discharge and 4-week post discharge
Changes in SPPB score
Secondary Outcomes
- Hand grip strength (kg)(at pre-testing, 1-week post discharge and 4-week post discharge)
- Body Composition(at pre-testing, 1-week post discharge and 4-week post discharge)
- ADLS, IADLS(at pre-testing, 1-week post discharge and 4-week post discharge)
- Physical Activity Levels(at pre-testing, 1-week post discharge and 4-week post discharge)
- Blood Measures(at pre-testing, 1-week post discharge and 4-week post discharge)
- 30 day re-hospitalization(30 days post-discharge)
- Gait Speed (m/s)(at pre-testing, 1-week post discharge and 4-week post discharge)