Clinical trial NCT00345969: Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Official title: Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Physical Frailty
Hip Fracture
Elective Hip Replacement
Hypogonadism
Keywords: Testosterone Replacement Therapy
Physical Frailty
Hip Fracture
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Solvay Pharmaceuticals
First posted: 2006-06-29
Enrollment: 25
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Mean Change in Total Lean Body Mass
timeFrame: Baseline and Six Months
measure: Change in Skeletal Muscle Strength by 1-RM
timeFrame: Baseline and Six Months
Secondary outcomes:
measure: Change in Isokinetic Leg Extension Torque at 0 Deg/Sec
timeFrame: Baseline and Six Months
measure: Change in Leg Extension Torque at 60 Deg/Sec
timeFrame: Baseline and Six Months
measure: Change in Total Body Fat Mass
timeFrame: Baseline and Six Months
measure: Change in Femoral Bone Mineral Density (BMD)
timeFrame: Baseline and Six Months
measure: Change in Total Modified Physical Performance (mPPT) Score
timeFrame: Baseline and Six Months
measure: Change in Serum Testosterone Level
timeFrame: Baseline and Six Months
Other outcomes:
measure: Change in Serum Prostate Specific Antigen (PSA) Level
timeFrame: Baseline and Six Months
measure: Change in Hematocrit
timeFrame: Baseline and Six Months
measure: Change in Serum Total Cholesterol Level
timeFrame: Baseline and Six Months
measure: Change in Serum HDL Cholesterol Level
timeFrame: Baseline and Six Months
measure: Change in Serum LDL Cholesterol Level
timeFrame: Baseline and Six Months
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ellen F. Binder, MD
role: PRINCIPAL_INVESTIGATOR
References: