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Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

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ClinicalTrials.gov Identifier: NCT00345969
Recruitment Status : Completed
First Posted : June 29, 2006
Results First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Ellen F. Binder, MD, Washington University School of Medicine

June 27, 2006
June 29, 2006
January 15, 2016
February 21, 2018
February 21, 2018
November 2004
February 2009   (Final data collection date for primary outcome measure)
  • 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
  • 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
Complete list of historical versions of study NCT00345969 on ClinicalTrials.gov Archive Site
  • 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)
  • 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
  • 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 ]
Not Provided
 
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Physical Frailty
  • Hip Fracture
  • Elective Hip Replacement
  • Hypogonadism
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
22
August 2009
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
65 Years and older   (Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00345969
HSC 02-1108
No
Not Provided
Plan to Share IPD: No
Ellen F. Binder, MD, Washington University School of Medicine
Washington University School of Medicine
Solvay Pharmaceuticals
Principal Investigator: Ellen F. Binder, MD Washington University School of Medicine
Washington University School of Medicine
January 2018

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