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Exercise and Testosterone Therapy in Elderly Men With Physical Frailty

This study has been completed.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Ellen F. Binder, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00345969
First received: June 27, 2006
Last updated: April 17, 2012
Last verified: April 2012
  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 3

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:


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: 25
Study Start Date: November 2004
Study Completion Date: August 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, MD, Associate Professor, 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 17, 2012
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:
Hip Fractures
Hypogonadism
Endocrine System Diseases
Femoral Fractures
Fractures, Bone
Gonadal Disorders
Hip Injuries
Leg Injuries
Wounds and Injuries
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014