TerminatedEarly Phase 1

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

Stopped: Lack of funding.

United States3 participantsStarted 2016-02-16

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or Female
. Ages: 60 years or older
. Starting rehabilitative care

Exclusion criteria

. Inability to perform the functional tests specific to the study protocol
. Diagnosed with carcinomas of the breast or with known or suspected carcinomas of the prostate.
. Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes).
. Uncontrolled hypertension. Systolic blood pressure =/\> 160mm Hg or a diastolic blood pressure =/\> 100mm Hg on three consecutive measurements taken at one-week intervals. Testosterone, other anabolic steroids and glucocorticoids can cause fluid retention that could worsen uncontrolled hypertension. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA)

Timeframe: 0 to 10 Weeks

Trial details

NCT IDNCT02679274

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09-20

Results submitted2017-10-25

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