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

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Aging

Treatments: Drug: Placebo; Drug: Testosterone; Behavioral: In-home exercise; Dietary Supplement: Nutritional Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02203656

1229

13-038

Details and patient eligibility

About

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.

Full 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

Enrollment: 113 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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113 participants in 5 patient groups, including a placebo group

Placebo Supplement

Placebo Comparator group

Description:

Daily placebo supplement for 30 days after discharge.

Treatment:

Drug: Placebo

Nutritional Supplement

Experimental group

Description:

Daily nutritional supplement for 30 days after discharge.

Treatment:

Dietary Supplement: Nutritional Supplement

In-home exercise + placebo

Experimental group

Description:

in-home exercise 3 times a week and daily placebo supplement for 30 days after discharge.

Treatment:

Behavioral: In-home exercise

Drug: Placebo

In-home exercise + nutrition

Experimental group

Description:

in-home exercise 3 times a week and daily nutritional supplement for 30 days after discharge.

Treatment:

Dietary Supplement: Nutritional Supplement

Behavioral: In-home exercise

Testosterone

Experimental group

Description:

Single testosterone injection within 24 hours of hospital discharge.

Treatment:

Drug: Testosterone