Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

Hypogonadism Clinical Trial

Official title:

Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345969
• Other study ID #: HSC 02-1108
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2006
• Last updated: January 22, 2018
• Start date: November 2004
• Est. completion date: August 2009

Study information

• Verified date: January 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elective Hip Replacement
• Hip Fracture
• Hip Fractures
• Hypogonadism
• Physical Frailty

Intervention

Drug:
• Transdermal Testosterone gel (1%)
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:
• Supervised exercise training
Supervised exercise training performed on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and physical therapy-type exercises, followed by 4 months of progressive resistance training.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Serum Prostate Specific Antigen (PSA) Level		Baseline and Six Months
Other	Change in Hematocrit	Percentage of the volume of whole blood composed of Red Blood Cells	Baseline and Six Months
Other	Change in Serum Total Cholesterol Level		Baseline and Six Months
Other	Change in Serum HDL Cholesterol Level		Baseline and Six Months
Other	Change in Serum LDL Cholesterol Level		Baseline and Six Months
Primary	Mean Change in Total Lean Body Mass	Total Lean Mass measured by Dual X-ray Absorptiometry (DXA)	Baseline and Six Months
Primary	Change in Skeletal Muscle Strength by 1-RM	One-repetition maximum strength for leg extension	Baseline and Six Months
Secondary	Change in Isokinetic Leg Extension Torque at 0 Deg/Sec	Leg Extension Torque measured with Cybex dynamometer at 0 deg/sec	Baseline and Six Months
Secondary	Change in Leg Extension Torque at 60 Deg/Sec	Leg Extension Torque measured with Cybex dynamometry at 60 deg/sec	Baseline and Six Months
Secondary	Change in Total Body Fat Mass	Total Body Fat Mass as measured by DXA	Baseline and Six Months
Secondary	Change in Femoral Bone Mineral Density (BMD)	Femoral Bone Mineral Density measured with Dual X-ray Absorptiometry (DXA)	Baseline and Six Months
Secondary	Change in Total Modified Physical Performance (mPPT) Score	The Modified Physical Performance Test (mPPT) is a direct observational test that assesses multiple dimensions of physical function (basic and complex activities of daily living [ADL]) with different levels of difficulty. The test consists of 9 performance tasks. The total score range is 0-36 (min-max), with higher scores indicating better performance. Sub-scores are assigned for each of 9 item tasks; sub-score range is 0-4 (min-max) with higher scores indicating better performance. The sub-scores are summed to compute the total score.	Baseline and Six Months
Secondary	Change in Serum Testosterone Level	Total Serum Testosterone Level (ng/mL)	Baseline and Six Months