Clinical trial NCT02203656: Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults
Official title: Feasibility Study of Post-hospitalization Interventions to Improve Physical Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aging
Keywords: intervention studies
nutrition
exercise
testosterone
patient readmission
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Dairy Research Institute
name: National Dairy Council
First posted: 2014-07-30
Enrollment: 113
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Short Physical Performance Battery- Gait, Balance, Chair Rise changes in functional measure score
timeFrame: at pre-testing, 1-week post discharge and 4-week post discharge
Secondary outcomes:
measure: Body Composition
timeFrame: at pre-testing, 1-week post discharge and 4-week post discharge
measure: Hand grip strength (kg)
timeFrame: at pre-testing, 1-week post discharge and 4-week post discharge
measure: ADLS, IADLS
timeFrame: at pre-testing, 1-week post discharge and 4-week post discharge
measure: Physical Activity Levels
timeFrame: at pre-testing, 1-week post discharge and 4-week post discharge
measure: Gait Speed (m/s)
timeFrame: at pre-testing, 1-week post discharge and 4-week post discharge
measure: Blood Measures
timeFrame: at pre-testing, 1-week post discharge and 4-week post discharge
measure: 30 day re-hospitalization
timeFrame: 30 days post-discharge
Other outcomes:
measure: Follow-up Measures
timeFrame: 1 year post discharge
Locations:
city: Galveston
country: United States
facility: UTMB Acute Care for Elders Unit
state: Texas
city: Galveston
country: United States
facility: Jennie Sealy Hospital
state: Texas
Study officials:
affiliation: UTMB
name: Elena Volpi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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 Sci. 2018 Jan 16;73(2):187-193. doi: 10.1093/gerona/glx111.
citation: 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. 2019 Sep 15;74(10):1628-1636. doi: 10.1093/gerona/glz084.