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Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents

NCT02679274 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-02-18

Study results available
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Summary

Frailty is a recognized cause for disability, hospitalization, and mortality in nursing home residents. Testosterone treatment is among the potentially beneficial treatments in addition to resistance exercise for improving muscle strength and mass in frail adults. The investigators have demonstrated that cycled administration of testosterone improves muscle mass and strength in healthy adults. It is proposed that cycled testosterone administration may be an effective adjuvant therapy for frail older men and women during rehabilitation programs. The hypothesis is that testosterone treatment in addition to standard-of-care (SOC) rehabilitation will result in improved muscle mass and physical function when compared to patients receiving SOC only. Therefore, in a randomized, double-blind, placebo controlled study, the investigators will test the effects of cycled testosterone administration (2 week on treatment, 2 weeks off treatment) on body composition and physical function in male and female nursing home residents undergoing rehabilitative care. Primary outcomes will be assessed before and after 10 weeks of treatment using bioelectric impedance, handgrip dynamometers, short physical performance battery (SPPB), and quality of life (QOL) questionnaires. Data from this pilot project will become the foundation for the development of a larger long-term project solicitation to the NIH aimed at elucidating the efficacy of testosterone treatment on physical function and independence in frail older adults.

Conditions

  • Aging

Interventions

DRUG

Placebo

Intermittent intramuscular injections of saline (males and females).

DRUG

Testosterone

Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Edgar L Dillon, PhD · University of Texas Medical Branch (UTMB)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-16
Primary Completion
2016-09-20
Completion
2016-09-20

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02679274 on ClinicalTrials.gov