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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
Last Update Posted : April 19, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 27, 2006
June 29, 2006
April 19, 2012
November 2004
February 2009   (Final data collection date for primary outcome measure)
  • Total and regional body composition by dual energy x-ray absorptiometry [ Time Frame: Six months ]
  • Skeletal muscle strength by 1-RM and isokinetic dynamometry [ Time Frame: Six months ]
  • Modified Physical Performance Test score [ Time Frame: Six months ]
  • Gait speed [ Time Frame: Six months ]
  • 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
  • Total and regional bone density by dual energy x-ray absorptiometry [ Time Frame: Six months ]
  • Self-report of performance of activities of daily living [ Time Frame: Six months ]
  • SF-36 quality of life [ Time Frame: Six months ]
  • Chalder Fatigue Scale [ Time Frame: Six months ]
  • Hematocrit [ Time Frame: Six months ]
  • Serum PSA level [ Time Frame: Six months ]
  • Serum lipids [ Time Frame: Six months ]
  • 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
Not Provided
Not Provided
 
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
The purpose of this study is to determine, in older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve physical function, muscle mass, bone density,and quality of life, 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 purpose of this study is to determine, in older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve physical function, muscle mass, bone density, and quality of life, to a greater degree than 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) exercise training + testosterone replacement therapy for six months vs. 2) exercise training + placebo for six months.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Frailty
  • Hip Fracture
  • Hip Arthroplasty
  • Hypogonadism
  • Drug: Testosterone replacement therapy
    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.
  • Behavioral: Exercise training
    Six months of supervised exercise training on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and low resistance exercises, followed by 4 months of progressive resistance training.
  • Active Comparator: Exercise + Testosterone Replacement
    Interventions:
    • Drug: Testosterone replacement therapy
    • Behavioral: Exercise training
  • Placebo Comparator: Exercise + Placebo
    Intervention: Behavioral: 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
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00345969
HSC 02-1108
Not Provided
Not Provided
Not Provided
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
April 2012

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