Feasibility Study of Post-hospitalization Interventions to Improve Physical Function in Older Adults

Phase 1

Completed

• Conditions: Aging
• Interventions: Dietary Supplement: Nutritional Supplement; Drug: Placebo; Drug: Testosterone; Behavioral: In-home exercise

• Registration Number: NCT02203656
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Primary Completion: 2016-07
• Status Verified: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Nutritional Supplement	Nutritional Supplement	Daily nutritional supplement for 30 days after discharge.
In-home exercise + placebo	Placebo	in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.
In-home exercise + nutrition	Nutritional Supplement	in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.
Placebo Supplement	Placebo	Daily placebo supplement for 30 days after discharge.
In-home exercise + placebo	In-home exercise	in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.
In-home exercise + nutrition	In-home exercise	in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.
Testosterone	Testosterone	Single testosterone injection within 24 hours of hospital discharge.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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
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
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.

Trial Locations

Locations (2)

UTMB Acute Care for Elders Unit; 🇺🇸 Galveston, Texas, United States

Jennie Sealy Hospital; 🇺🇸 Galveston, Texas, United States