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Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly

Primary Purpose

Muscle Weakness, Muscular Atrophy

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
exercise
testosterone
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Muscle Weakness focused on measuring Aging, nutrition, rehabilitation

Eligibility Criteria

65 Years - undefined (Older Adult)MaleDoes not accept healthy volunteers

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:

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 3, 2001
Last Updated
June 22, 2011
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00018356
Brief Title
Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly
Official Title
Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Muscular Atrophy
Keywords
Aging, nutrition, rehabilitation

7. Study Design

Study Phase
Phase 4
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
exercise
Intervention Type
Drug
Intervention Name(s)
testosterone

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Sullivan, MD
Organizational Affiliation
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
City
No. Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114-1706
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16260965
Citation
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. doi: 10.1249/01.mss.0000181840.54860.8b.
Results Reference
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Learn more about this trial

Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly

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