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Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

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: NCT00345969
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Ellen F. Binder, MD, Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE June 27, 2006
First Posted Date  ICMJE June 29, 2006
Results First Submitted Date  ICMJE January 15, 2016
Results First Posted Date  ICMJE February 22, 2018
Last Update Posted Date February 22, 2018
Study Start Date  ICMJE November 2004
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • Mean Change in Total Lean Body Mass [ Time Frame: Baseline and Six Months ]
    Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)
  • Change in Skeletal Muscle Strength by 1-RM [ Time Frame: Baseline and Six Months ]
    One-repetition maximum strength for leg extension
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2006)
  • Thigh cross sectional area by MRI
  • Total and regional body composition by dual energy x-ray absorptiometry
  • Skeletal muscle strength by 1-RM and isokinetic dynamometry
  • Modified Physical Performance Test score
  • Gait speed
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • Change in Isokinetic Leg Extension Torque at 0 Deg/Sec [ Time Frame: Baseline and Six Months ]
    Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec
  • Change in Leg Extension Torque at 60 Deg/Sec [ Time Frame: Baseline and Six Months ]
    Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec
  • Change in Total Body Fat Mass [ Time Frame: Baseline and Six Months ]
    Total Body Fat Mass as measured by DXA
  • Change in Femoral Bone Mineral Density (BMD) [ Time Frame: Baseline and Six Months ]
    Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)
  • Change in Total Modified Physical Performance (mPPT) Score [ Time Frame: Baseline and Six Months ]
    The Modified Physical Performance Test (mPPT) is a direct observational test that assesses multiple dimensions of physical function (basic and complex activities of daily living [ADL]) with different levels of difficulty. The test consists of 9 performance tasks. The total score range is 0-36 (min-max), with higher scores indicating better performance. Sub-scores are assigned for each of 9 item tasks; sub-score range is 0-4 (min-max) with higher scores indicating better performance. The sub-scores are summed to compute the total score.
  • Change in Serum Testosterone Level [ Time Frame: Baseline and Six Months ]
    Total Serum Testosterone Level (ng/mL)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2006)
  • Total and regional bone density by dual energy x-ray absorptiometry
  • Self-report of performance of activities of daily living
  • SF-36 quality of life
  • Chalder Fatigue Scale
Current Other Pre-specified Outcome Measures
 (submitted: January 22, 2018)
  • Change in Serum Prostate Specific Antigen (PSA) Level [ Time Frame: Baseline and Six Months ]
  • Change in Hematocrit [ Time Frame: Baseline and Six Months ]
    Percentage of the volume of whole blood composed of Red Blood Cells
  • Change in Serum Total Cholesterol Level [ Time Frame: Baseline and Six Months ]
  • Change in Serum HDL Cholesterol Level [ Time Frame: Baseline and Six Months ]
  • Change in Serum LDL Cholesterol Level [ Time Frame: Baseline and Six Months ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Official Title  ICMJE Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Brief Summary The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.
Detailed Description

Decreases in physical abilities, including losses of strength, endurance, balance, and coordination are major causes of disability and loss of independence in older men. Such individuals are at high risk for injurious falls, hospitalization, and use of supportive services. Age-associated testosterone deficiency may contribute to deficits in muscle mass and strength that are common in this patient population.

The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve skeletal muscle mass and skeletal muscle strength, to a greater degree than six months of exercise training alone.

Secondary study aims are to determine in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve physical function, bone mineral density, and quality of life, to a greater degree than six months of exercise training alone.

Comparison: Men age 65 years and older who meet criteria for physical frailty and have a serum testosterone level below 350 ng/dl are randomly assigned to one of two groups: 1) transdermal testosterone replacement therapy + supervised exercise training for six months vs. 2) inactive placebo gel + supervised exercise training for six months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Physical Frailty
  • Hip Fracture
  • Elective Hip Replacement
  • Hypogonadism
Intervention  ICMJE
  • Drug: Transdermal Testosterone gel (1%)
    Transdermal testosterone replacement therapy with Androgel(TM). Daily application of gel at 5 mg, 7.5 gm, or 10 gm for six months. Target serum total testosterone level between 500-900 ng/dl.
    Other Name: Androgel
  • Behavioral: Supervised exercise training
    Supervised exercise training performed on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and physical therapy-type exercises, followed by 4 months of progressive resistance training.
Study Arms  ICMJE
  • Active Comparator: Transdermal Testosterone gel (1%)
    Transdermal testosterone 1% gel (Androgel) provided as 2.5 gm and/or 5 gm gel packets with dose titration and monthly dose adjustments to achieve and maintain serum total testosterone level between 500-900 mg/dL. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months.
    Interventions:
    • Drug: Transdermal Testosterone gel (1%)
    • Behavioral: Supervised exercise training
  • Placebo Comparator: Placebo gel
    Inactive topical gel identical in appearance to the active medication, provided in packets identical to the packaging for the active medication. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months.
    Intervention: Behavioral: Supervised exercise training
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2012)
25
Original Enrollment  ICMJE
 (submitted: June 27, 2006)
22
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male, age 65 years and older
  • Total serum testosterone level < 350 ng/dl
  • Total Modified Physical Performance Test Score <28

Exclusion Criteria:

  • Inability to walk 50 feet independently
  • Current use of estrogen, progestin, or androgen containing compound
  • Diagnosis of dementia of severity sufficient to interfere with informed consent or compliance with the protocol, or a score of 11 or greater on the Short Blessed Test of Orientation, Memory and Concentration
  • Visual or hearing impairments that interfere with following directions
  • Cardiopulmonary disease (recent MI, unstable angina or CHF, etc.), neuromuscular impairments, or unstable medical condition that would contraindicate progressive resistance exercise training
  • History of prostate cancer or hormone dependent neoplasia
  • PSA level > 4 ng/ml
  • Serum liver transaminase levels of greater than 2 standard deviations above normal
  • Use of drugs for osteoporosis for less than 1 year
  • Current participation in a vigorous exercise or weight-training program more than once per week
  • History of sleep apnea requiring use of CPAP
  • Uncontrolled thyroid disease
  • Diagnosis of cancer within the past 5 years other than superficial skin cancer (squamous or basal cell)
  • hematocrit > 50%
  • AUA symptom score > 16.
  • History of alcohol or substance abuse
  • Presence of severe facial acne
  • Active symptoms of depression with GDS score > 5 and symptoms severe enough to cause >5% weight loss in previous 3 months or interfere with research assessments
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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 NCT00345969
Other Study ID Numbers  ICMJE HSC 02-1108
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ellen F. Binder, MD, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Solvay Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Ellen F. Binder, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date January 2018

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