Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients

Phase 1

Completed

• Conditions: Aging
• Interventions: Drug: Testosterone; Other: Placebo Injection; Dietary Supplement: Protein Supplement; Other: Placebo supplement

• Registration Number: NCT02990533
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

The goal of this pilot study is to collect preliminary data on the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Detailed Description

The purpose of this pilot study is to test the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-13
• Primary Completion: 2020-11-08
• Study Completion: 2020-11-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Admitted to the UTMB hospital
• 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
• Alert and oriented x3 by a physician on H&P.
• Discharged "to home" at hospital discharge. Participation in the study will be terminated in those subjects not discharged to home after hospital stay.

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Exclusion Criteria

• A Nursing home resident or hospice care patient
• Uncontrolled blood pressure (systolic >170, or diastolic > 100)
• New onset motor disability that prevents walking at the time of baseline testing (stroke with motor disability, lower limb orthopedic dx)
• End stage renal disease
• AST/ALT 2.5 times above the normal limit
• Recent (within 3 months) or current treatment with anabolic steroids.
• History of 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)
• Hematocrit ≥ 50%
• Any other condition or event considered exclusionary by the PI and faculty physician

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo supplement	Placebo Supplement Placebo Injection
Testosterone	Testosterone	Placebo Supplement Testosterone Injection
Testosterone	Placebo supplement	Placebo Supplement Testosterone Injection
Placebo	Placebo Injection	Placebo Supplement Placebo Injection
Protein Supplement	Protein Supplement	Protein Supplement Placebo Injection
Protein Supplement	Placebo Injection	Protein Supplement Placebo Injection
Protein Supplement + Testosterone	Testosterone	Protein Supplement Testosterone Injection
Protein Supplement + Testosterone	Protein Supplement	Protein Supplement Testosterone Injection

Primary Outcome Measures

Name	Time	Method
Physical Performance	Change from Baseline to 30-day Followup	Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance

Secondary Outcome Measures

Name	Time	Method
Handgrip Strength	Change from Baseline to 30-day Followup	strength by handheld dynamometer, kg
Physical Activity Level	Change from Baseline to 30-day Followup	Number of daily steps
30 day re-admission	30 days post-discharge	Readmission within 30 days of hospital discharge

Trial Locations

Locations (1)

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