Aging Clinical Trial
— PACEOfficial title:
Feasibility Study of Post-hospitalization Interventions to Improve Physical Function
Verified date | December 2017 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 113 |
Est. completion date | December 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Jennie Sealy Hospital | Galveston | Texas |
United States | UTMB Acute Care for Elders Unit | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston | Dairy Research Institute, National Dairy Council |
United States,
Deer RR, Dickinson JM, Baillargeon J, Fisher SR, Raji M, Volpi E. A Phase I Randomized Clinical Trial of Evidence-Based, Pragmatic Interventions to Improve Functional Recovery After Hospitalization in Geriatric Patients. J Gerontol A Biol Sci Med Sci. 201 — View Citation
Deer RR, Dickinson JM, Fisher SR, Ju H, Volpi E. Identifying effective and feasible interventions to accelerate functional recovery from hospitalization in older adults: A randomized controlled pilot trial. Contemp Clin Trials. 2016 Jul;49:6-14. doi: 10.1016/j.cct.2016.05.001. Epub 2016 May 10. — View Citation
Deer RR, Goodlett SM, Fisher SR, Baillargeon J, Dickinson JM, Raji M, Volpi E. A Randomized Controlled Pilot Trial of Interventions to Improve Functional Recovery After Hospitalization in Older Adults: Feasibility and Adherence. J Gerontol A Biol Sci Med — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Follow-up Measures | Rehospitalization: date of rehospitalization, duration, and discharge diagnosis Death: date of death | 1 year post discharge | |
Primary | Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score | Changes in SPPB score | at pre-testing, 1-week post discharge and 4-week post discharge | |
Secondary | Body Composition | Body composition will be measured using a bioimpedance scale. Changes in weight and % body fat will be calculated over the duration of the intervention. | at pre-testing, 1-week post discharge and 4-week post discharge | |
Secondary | Hand grip strength (kg) | Changes in hand grip will be calculated over duration of study. | at pre-testing, 1-week post discharge and 4-week post discharge | |
Secondary | ADLS, IADLS | Changes in Instrumental activities of daily living (IADLS), and Activities of daily living (ADLS) will be measured over the duration of the intervention. | at pre-testing, 1-week post discharge and 4-week post discharge | |
Secondary | Physical Activity Levels | Physical activity levels will be measured using a step activity monitor and actiwatch | at pre-testing, 1-week post discharge and 4-week post discharge | |
Secondary | Gait Speed (m/s) | Changes in gait speed will be calculated over duration of study. | at pre-testing, 1-week post discharge and 4-week post discharge | |
Secondary | Blood Measures | microRNA levels in blood will be measured | at pre-testing, 1-week post discharge and 4-week post discharge | |
Secondary | 30 day re-hospitalization | re-hospitalization rates will be collected | 30 days post-discharge |
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