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

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: NCT02679274
Recruitment Status : Terminated (Lack of funding.)
First Posted : February 10, 2016
Results First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief 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.

Condition or disease Intervention/treatment Phase
Aging Drug: Placebo Drug: Testosterone Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Cycled Testosterone Therapy to Improve Physical Function in Frail Nursing Home Residents
Actual Study Start Date : February 16, 2016
Actual Primary Completion Date : September 20, 2016
Actual Study Completion Date : September 20, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo injection (saline) to be received on weeks 0, 1, 4, 5, 8 and 9.
Drug: Placebo
Intermittent intramuscular injections of saline (males and females).
Other Name: Saline

Experimental: Testosterone
Testosterone Enanthate injections (25mg/injection females; 100mg/injection males) to be received on weeks 0, 1, 4, 5, 8 and 9.
Drug: Testosterone
Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
Other Name: Testosterone Enanthate




Primary Outcome Measures :
  1. Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA) [ Time Frame: 0 to 10 Weeks ]
    Fat-free Mass (kg) calculated from total weight (kg) and percent body fat (%) obtained during bioelectric impedance analysis (BIA).


Secondary Outcome Measures :
  1. Change in Handgrip Strength [ Time Frame: 0 to 10 Weeks ]
    Measured using a handgrip dynamometer

  2. Change in Knee Extension Strength (Seated) [ Time Frame: 0 to 10 Weeks ]
    Collected using a manual muscle tester (MMT).

  3. Change in Hip Abduction Strength (Supine) [ Time Frame: 0 to 10 Weeks ]
    Collected using a manual muscle tester (MMT).

  4. Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline [ Time Frame: baseline ]
    During the Short Physical Performance Battery (SPPB) side by side balance test subjects are asked to stand with their feet together and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.

  5. Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks [ Time Frame: 10 Weeks ]
    During the Short Physical Performance Battery (SPPB) side by side balance test subjects are asked to stand with their feet together and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.

  6. Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline [ Time Frame: baseline ]
    During the Semi-Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a semi-tandem stance (heel of one foot placed to side of the first toe of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.

  7. Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks. [ Time Frame: 10 Weeks ]
    During the Semi-Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a semi-tandem stance (heel of one foot placed to side of the first toe of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.

  8. Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline [ Time Frame: baseline ]
    During the Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a tandem stance (heel of one foot directly in front of the toes of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.

  9. Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks [ Time Frame: 10 Weeks ]
    During the Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a tandem stance (heel of one foot directly in front of the toes of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.

  10. Change in Gait Speed as Measured by Short Physical Performance Battery (SPPB). [ Time Frame: 0 to 10 Weeks ]
    During the gait speed section of the Short Physical Performance Battery (SPPB) subjects are timed while walking a predefined 4 meter course. Data is shown as change in speed (meters/second) from baseline (0 weeks) to 10 weeks. A increase in speed indicates a better outcome.

  11. Chair Raise as Measured by Short Physical Performance Battery (SPPB) at Baseline [ Time Frame: baseline ]
    During the chair rise section of the Short Physical Performance Battery (SPPB), subjects are timed while they rise from a seated (chair) to standing position. Subjects perform this task 5 times and data is presented as their faster time.

  12. Chair Raise as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks [ Time Frame: 10 Weeks ]
    During the chair rise section of the Short Physical Performance Battery (SPPB), subjects are timed while they rise from a seated (chair) to standing position. Subjects perform this task 5 times and data is presented as their best time.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Inability to perform the functional tests specific to the study protocol
  2. Diagnosed with carcinomas of the breast or with known or suspected carcinomas of the prostate.
  3. Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes).
  4. 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.
  5. History of significant liver disorders or a 3-fold elevation of liver function tests (Alk phos, ALT, AST). Testosterone can have hepatotoxic effects in some subjects and should be used with careful monitoring of LFTs (liver function), though injections of testosterone at a 100 mg dose is not typically sufficient to negatively affect LFTs.
  6. History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months.
  7. LDL cholesterol greater than 200 mg/dL as testosterone administration may elevate LDL cholesterol levels further, though this is not anticipated with testosterone injections of 100 mg/wk.
  8. Hematocrit greater than 51%.
  9. Established chronic obstructive pulmonary disease, or untreated sleep apnea.
  10. Implanted artificial pacemaker/defibrillator. BIA uses small currents and is not recommended for participants with a pacemaker.
  11. Diagnosed systemic fungal infections.
  12. Positive screening for HIV or active hepatitis*.
  13. Use of or history of recent anabolic steroid use (within 3 months).
  14. Alcohol or drug abuse.
  15. Any other condition or event considered exclusionary by the PI and covering faculty physician.
  16. Vulnerable populations including: individuals unable to consent on their own behalf, prisoners and pregnant women.

    • Subjects excluded due to positive screening results, including HIV, HBV or HCV, will be immediately scheduled for counseling and follow-up testing as needed, and will be advised to consult their primary physician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679274


Locations
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United States, Texas
Gulf Health Care Center
Galveston, Texas, United States, 77555
Gulf Health Care Center
Texas City, Texas, United States, 77590
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Edgar L Dillon, PhD University of Texas Medical Branch (UTMB)
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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02679274    
Other Study ID Numbers: 15-0176
First Posted: February 10, 2016    Key Record Dates
Results First Posted: February 18, 2019
Last Update Posted: February 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The University of Texas Medical Branch, Galveston:
Aging, Frailty, Hypogonadism
Additional relevant MeSH terms:
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Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents