Status:
COMPLETED
Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Physical Frailty
Hip Fracture
Eligibility:
MALE
65+ years
Phase:
PHASE3
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 stre...
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 r...
Eligibility Criteria
Inclusion
- Male, age 65 years and older
- Total serum testosterone level \< 350 ng/dl
- Total Modified Physical Performance Test Score \<28
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00345969
Start Date
November 1 2004
End Date
August 1 2009
Last Update
February 22 2018
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110