Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Information source: Washington University School of Medicine
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Frailty; Hip Fracture; Hip Arthroplasty; Hypogonadism
Intervention: Testosterone replacement therapy (Drug); Exercise training (Behavioral)
Phase: Phase 3
Status: Recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s):
Ellen F. Binder, MD, Principal Investigator, Affiliation: Washington University School of Medicine
Overall contact:
Toni Gordon, RN, Phone: 314-286-2716, Email: tgordon@wustl.edu
Summary
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.
Clinical Details
Official title: Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Thigh cross sectional area by MRITotal 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
Secondary outcome: Total and regional bone density by dual energy x-ray absorptiometrySelf-report of performance of activities of daily living SF-36 quality of life Chalder Fatigue Scale
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 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.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Toni Gordon, RN, Phone: 314-286-2716, Email: tgordon@wustl.edu
Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Additional Information
Starting date: November 2004
Ending date: March 2008
Last updated: June 27, 2006
|
