Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

The Washington University

Status and phase: Completed; Phase 3

Conditions: Hip Fracture; Elective Hip Replacement; Physical Frailty; Hypogonadism

Treatments: Drug: Transdermal Testosterone gel (1%); Behavioral: Supervised exercise training

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00345969

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Male

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

Transdermal Testosterone gel (1%)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Supervised exercise training

Drug: Transdermal Testosterone gel (1%)

Placebo gel

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Supervised exercise training