Aging
Conditions
Keywords
intervention studies, nutrition, exercise, testosterone, patient readmission
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
Interventions
DRUGPlacebo
placebo supplement
DIETARY_SUPPLEMENTNutritional Supplement
protein supplement
BEHAVIORALIn-home exercise
In-home exercise program
DRUGTestosterone
Testosterone injection
Sponsors
Dairy Research Institute
National Dairy Council
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score | at pre-testing, 1-week post discharge and 4-week post discharge | Changes in SPPB score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | at pre-testing, 1-week post discharge and 4-week post discharge | Body composition will be measured using a bioimpedance scale. Changes in weight and % body fat will be calculated over the duration of the intervention. |
| Hand grip strength (kg) | at pre-testing, 1-week post discharge and 4-week post discharge | Changes in hand grip will be calculated over duration of study. |
| ADLS, IADLS | at pre-testing, 1-week post discharge and 4-week post discharge | Changes in Instrumental activities of daily living (IADLS), and Activities of daily living (ADLS) will be measured over the duration of the intervention. |
| Gait Speed (m/s) | at pre-testing, 1-week post discharge and 4-week post discharge | Changes in gait speed will be calculated over duration of study. |
| Blood Measures | at pre-testing, 1-week post discharge and 4-week post discharge | microRNA levels in blood will be measured |
| 30 day re-hospitalization | 30 days post-discharge | re-hospitalization rates will be collected |
| Physical Activity Levels | at pre-testing, 1-week post discharge and 4-week post discharge | Physical activity levels will be measured using a step activity monitor and actiwatch |
Other
| Measure | Time frame | Description |
|---|---|---|
| Follow-up Measures | 1 year post discharge | Rehospitalization: date of rehospitalization, duration, and discharge diagnosis Death: date of death |
Countries
United States
Outcome results
None listed