CompletedNCT02990533GRAMSUpdated Dec 17, 2024

Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients

A Phase 1 interventional study of Testosterone and Protein Supplement in Aging, sponsored by The University of Texas Medical Branch, Galveston. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.

Sponsored by The University of Texas Medical Branch, Galveston · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Nov 2020, 5 years 11 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: 65 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Aging

In context

Lead sponsor

The University of Texas Medical Branch, Galveston is the lead sponsor of 256 studies on the registry; 39 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.

Browse The University of Texas Medical Branch, Galveston studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 80 participants (actual)

Study arms

Placebo comparator
Placebo
Placebo Supplement Placebo Injection
Other: Placebo Injection · Other: Placebo supplement
Experimental
Testosterone
Placebo Supplement Testosterone Injection
Drug: Testosterone · Other: Placebo supplement
Experimental
Protein Supplement
Protein Supplement Placebo Injection
Dietary Supplement: Protein Supplement · Other: Placebo Injection
Experimental
Protein Supplement + Testosterone
Protein Supplement Testosterone Injection
Drug: Testosterone · Dietary Supplement: Protein Supplement

Interventions

DrugTestosterone
Also known as: testosterone enanthate
Dietary supplementProtein Supplement
Also known as: whey protein
OtherPlacebo Injection
Also known as: saline
OtherPlacebo supplement
Also known as: maltodextrin

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Jennie Sealy Hospital
Galveston, Texas 77555, United States

References and documents

Publications

Arentson-Lantz EJ, Boyle JT, Deer RR, Kokonda M, Bennetsen D, Carreon SA, Meers JM, Taffet G, Vahidy FS, Agarwal KS, Volpi E, Nowakowski S. Association of Sleep Disturbance and Physical Functioning Following Acute Hospitalisation in Older Adults. J Sleep Res. 2026 Jun;35(3):e70252. doi: 10.1111/jsr.70252. Epub 2025 Nov 29. PubMed 41316872 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02990533
Lead sponsor: The University of Texas Medical Branch, Galveston
Responsible party: Sponsor
First posted: Dec 13, 2016
Start date: Sep 2016
Primary completion: Nov 8, 2020
Completion: Nov 8, 2020
Last update: Dec 17, 2024

Study contacts

Elena Volpi, MD, PhD

study chair · UTMB

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Testosterone · Protein Supplement

Other studies from this sponsor

The University of Texas Medical Branch, Galveston →

Start the discussion