Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients

Aging Clinical Trial

— GRAMS  

Official title:

Translating Muscle Anabolic Strategies Into Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02990533
• Other study ID #: 16-0146
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 2016
• Est. completion date: November 2023

Study information

• Verified date: April 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: November 2023
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• Testosterone

Dietary Supplement:
• Protein Supplement

Other:
• Placebo Injection

• Placebo supplement

Locations

Country	Name	City	State
United States	Jennie Sealy Hospital	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Performance	Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance	Change from Baseline to 30-day Followup
Secondary	Handgrip Strength	strength by handheld dynamometer, kg	Change from Baseline to 30-day Followup
Secondary	Physical Activity Level	Number of daily steps	Change from Baseline to 30-day Followup
Secondary	30 day re-admission	Readmission within 30 days of hospital discharge	30 days post-discharge