Physiologic Effects of PRMS & Testosterone in the Debilit... | NCT00018356

Studies
Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly

NCT00018356

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

88Estimated

Phase

Phase 4

Conditions

Muscle Weakness
Muscular Atrophy

Interventions

exercise
testosterone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1999

Primary Completion Date

Jul 2006Actual

Completion Date

Aug 2006Actual

First Submitted Date

Jul 3, 2001

First Submission Date that Met QC Criteria

Jul 4, 2001

First Posted Date

Jul 5, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Label	Type	Description	Intervention Names
1	Other		Procedure: exercise Drug: testosterone

Name	Type	Description	Arm Group Labels	Other Names
exercise	Procedure		1
testosterone

Eligibility Module

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:

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dennis Sullivan, MD	Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock		No. Little Rock	Arkansas	72114-1706	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16260965	Result	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.

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations

ID	Term
D015444	Exercise
D013739	Testosterone

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

ID	Term
D018908	Muscle Weakness
D009133	Muscular Atrophy