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Completed

NCT Number: NCT02990533

Muscle Anabolic 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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jennie Sealy Hospital

Galveston, Texas, 77555, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone

Drug

Other names: testosterone enanthate

Protein Supplement

Dietary Supplement

Other names: whey protein

Placebo Injection

Other

Other names: saline

placebo supplement

Other

Other names: maltodextrin

Primary outcomes

  1. Physical Performance

    Time frame: Change from Baseline to 30-day Followup

    Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance

Secondary outcomes

  1. Handgrip Strength

    Time frame: Change from Baseline to 30-day Followup

    strength by handheld dynamometer, kg

  2. Physical Activity Level

    Time frame: Change from Baseline to 30-day Followup

    Number of daily steps

  3. 30 day re-admission

    Time frame: 30 days post-discharge

    Readmission within 30 days of hospital discharge

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

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

Acronym: GRAMS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2016
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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