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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990533
Recruitment Status : Active, not recruiting
First Posted : December 13, 2016
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Tracking Information
First Submitted Date  ICMJE October 25, 2016
First Posted Date  ICMJE December 13, 2016
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
Change in Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, Followup (30 days) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • Handgrip Strength [ Time Frame: Change from Baseline to 30-day Followup ]
    strength by handheld dynamometer, kg
  • Physical Activity Level [ Time Frame: Change from Baseline to 30-day Followup ]
    Number of daily steps
  • 30 day re-admission [ Time Frame: 30 days post-discharge ]
    Readmission within 30 days of hospital discharge
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
  • Change in Body Composition [ Time Frame: Baseline, Followup (30 days) ]
    Measure using bioimpedance scale
  • Change in Hand grip strength (kg) [ Time Frame: Baseline, Followup (30 days) ]
  • Change in level of independence [ Time Frame: Baseline, Followup (30 days) ]
    Measured using ADL/IADL score
  • Physical Activity Level [ Time Frame: Baseline, Followup (30 days) ]
    Measured using a step activity monitor
  • 30 day re-hospitalization [ Time Frame: 30 days post-discharge ]
    Readmission rates will be collected
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients
Official Title  ICMJE Translating Muscle Anabolic Strategies Into Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Aging
Intervention  ICMJE
  • Drug: Testosterone
    Other Name: testosterone enanthate
  • Dietary Supplement: Protein Supplement
    Other Name: whey protein
  • Other: Placebo Injection
    Other Name: saline
  • Other: Placebo supplement
    Other Name: maltodextrin
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo Supplement Placebo Injection
    Interventions:
    • Other: Placebo Injection
    • Other: Placebo supplement
  • Experimental: Testosterone
    Placebo Supplement Testosterone Injection
    Interventions:
    • Drug: Testosterone
    • Other: Placebo supplement
  • Experimental: Protein Supplement
    Protein Supplement Placebo Injection
    Interventions:
    • Dietary Supplement: Protein Supplement
    • Other: Placebo Injection
  • Experimental: Protein Supplement + Testosterone
    Protein Supplement Testosterone Injection
    Interventions:
    • Drug: Testosterone
    • Dietary Supplement: Protein Supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 8, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Actual Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990533
Other Study ID Numbers  ICMJE 16-0146
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The University of Texas Medical Branch, Galveston
Study Sponsor  ICMJE The University of Texas Medical Branch, Galveston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Elena Volpi, MD, PhD UTMB
PRS Account The University of Texas Medical Branch, Galveston
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP