Exercise and Testosterone Therapy in Elderly Men With Physical Frailty - Full Text View

Sponsor:	Washington University School of Medicine
Collaborator:	Solvay Pharmaceuticals
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00345969

Purpose

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.

Condition	Intervention	Phase
Frailty Hip Fracture Hip Arthroplasty Hypogonadism	Drug: Testosterone replacement therapy Behavioral: Exercise training	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Exercise and Physical Fitness Fractures Hip Injuries and Disorders X-Rays

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Total and regional body composition by dual energy x-ray absorptiometry [ Time Frame: Six months ] [ Designated as safety issue: No ]
Skeletal muscle strength by 1-RM and isokinetic dynamometry [ Time Frame: Six months ] [ Designated as safety issue: No ]
Modified Physical Performance Test score [ Time Frame: Six months ] [ Designated as safety issue: No ]
Gait speed [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total and regional bone density by dual energy x-ray absorptiometry [ Time Frame: Six months ] [ Designated as safety issue: No ]
Self-report of performance of activities of daily living [ Time Frame: Six months ] [ Designated as safety issue: No ]
SF-36 quality of life [ Time Frame: Six months ] [ Designated as safety issue: No ]
Chalder Fatigue Scale [ Time Frame: Six months ] [ Designated as safety issue: No ]
Hematocrit [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
Serum PSA level [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
Serum lipids [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Enrollment:	26
Study Start Date:	November 2004
Estimated Study Completion Date:	April 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Exercise + Testosterone Replacement	Drug: Testosterone replacement therapy 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: Exercise training Six months of supervised exercise training on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and low resistance exercises, followed by 4 months of progressive resistance training.
Placebo Comparator: Exercise + Placebo	Behavioral: Exercise training Six months of supervised exercise training on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and low resistance exercises, followed by 4 months of progressive resistance training.

Arms

Assigned Interventions

Active Comparator: Exercise + Testosterone Replacement

Drug: Testosterone replacement therapy

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: Exercise training

Six months of supervised exercise training on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and low resistance exercises, followed by 4 months of progressive resistance training.

Placebo Comparator: Exercise + Placebo

Behavioral: Exercise training

Six months of supervised exercise training on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and low resistance exercises, followed by 4 months of progressive resistance training.

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

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345969

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Solvay Pharmaceuticals

Investigators

Principal Investigator:

Ellen F. Binder, MD

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Ellen F. binder, Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00345969 History of Changes
Other Study ID Numbers:	HSC 02-1108
Study First Received:	June 27, 2006
Last Updated:	April 7, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

Testosterone Replacement Therapy
Physical Frailty
Hip Fracture

Additional relevant MeSH terms:

Fractures, Bone
Hip Fractures
Hypogonadism
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate

Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 09, 2012