Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly

This study has been completed.

First Received on July 3, 2001. Last Updated on June 22, 2011 History of Changes

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00018356

Purpose

This study's primary objective is to determine the independent and combined effects of progressive resistance muscle strength training and testosterone on the development of sustainable improvements in physical function.

Condition	Intervention	Phase
Muscle Weakness Muscular Atrophy	Procedure: exercise Drug: testosterone	Phase IV

Study Type:	Interventional
Official Title:	Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:	88
Study Start Date:	January 1999
Study Completion Date:	August 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Procedure: exercise Drug: testosterone

Eligibility

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

Criteria

Inclusion Criteria:

The study will be limited to those patients who are metabolically stable and free of metastatic cancer and limiting end organ disease. Their total serum testosterone must be less than 480 and PSA less than 10.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018356

Locations

United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Dennis Sullivan, MD

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

More Information

Publications:

Sullivan DH, Roberson PK, Johnson LE, Bishara O, Evans WJ, Smith ES, Price JA. Effects of muscle strength training and testosterone in frail elderly males. Med Sci Sports Exerc. 2005 Oct;37(10):1664-72.

Responsible Party:	Sullivan, Dennis - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00018356 History of Changes
Other Study ID Numbers:	AGCG-007-98S
Study First Received:	July 3, 2001
Last Updated:	June 22, 2011
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Aging
nutrition
rehabilitation

Additional relevant MeSH terms:

Asthenia
Muscular Atrophy
Muscle Weakness
Paresis
Atrophy
Signs and Symptoms
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Muscular Diseases
Musculoskeletal Diseases
Pathologic Processes
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 12, 2012