Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients (GRAMS)

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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Drug: Testosterone; Other: Placebo Injection; Other: Placebo supplement; Dietary supplement: Protein Supplement

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • Jennie Sealy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Supplement Placebo Injection	Other: Placebo Injection; Other Names: saline; Other: Placebo supplement; Other Names: maltodextrin
Experimental: Testosterone; Placebo Supplement Testosterone Injection	Drug: Testosterone; Other Names: testosterone enanthate; Other: Placebo supplement; Other Names: maltodextrin
Experimental: Protein Supplement; Protein Supplement Placebo Injection	Other: Placebo Injection; Other Names: saline; Dietary supplement: Protein Supplement; Other Names: whey protein
Experimental: Protein Supplement + Testosterone; Protein Supplement Testosterone Injection	Drug: Testosterone; Other Names: testosterone enanthate; Dietary supplement: Protein Supplement; Other Names: whey protein

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Study Chair: Elena Volpi, MD, PhD, UTMB

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): November 8, 2020
• Study Completion (Actual): November 8, 2020

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimated): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anabolic Agents; Androgens; Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
• Other Study ID Numbers: 16-0146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No