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

Sponsor

The University of Texas Medical Branch, Galveston (Other)

Overall Status

Completed

CT.gov ID

NCT02203656

Collaborator

Dairy Research Institute (Other), National Dairy Council (Other)

113

Enrollment

Locations

Arms

Actual Duration (Months)

56.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging	Drug: Placebo Dietary Supplement: Nutritional Supplement Behavioral: In-home exercise Drug: Testosterone	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

113 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Feasibility Study of Post-hospitalization Interventions to Improve Physical Function

Actual Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Supplement Daily placebo supplement for 30 days after discharge.	Drug: Placebo placebo supplement Other Names: Control
Experimental: Nutritional Supplement Daily nutritional supplement for 30 days after discharge.	Dietary Supplement: Nutritional Supplement protein supplement
Experimental: In-home exercise + placebo in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.	Drug: Placebo placebo supplement Other Names: Control Behavioral: In-home exercise In-home exercise program
Experimental: In-home exercise + nutrition in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.	Dietary Supplement: Nutritional Supplement protein supplement Behavioral: In-home exercise In-home exercise program
Experimental: Testosterone Single testosterone injection within 24 hours of hospital discharge.	Drug: Testosterone Testosterone injection Other Names: Testosterone enanthate

Outcome Measures

Primary Outcome Measures

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

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.
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
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

Other Outcome Measures

Follow-up Measures [1 year post discharge]
Rehospitalization: date of rehospitalization, duration, and discharge diagnosis Death: date of death

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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