NCT00018356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

7.5 years

First QC Date

July 3, 2001

Last Update Submit

June 22, 2011

Conditions

Muscle WeaknessMuscular Atrophy

Keywords

Agingnutritionrehabilitation

Study Arms (1)

1

OTHER
Procedure: exerciseDrug: testosterone

Interventions

exercisePROCEDURE
1
testosteroneDRUG
1

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

No. Little Rock, Arkansas, 72114-1706, United States

Location

Related Publications (1)

  • 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.

    PMID: 16260965RESULT

MeSH Terms

Conditions

Muscle WeaknessMuscular Atrophy

Interventions

ExerciseTestosterone

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsAtrophyPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Dennis Sullivan, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
FED

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

January 1, 1999

Primary Completion

July 1, 2006

Study Completion

August 1, 2006

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

US(1)