Muscle WeaknessPhase 4NCT00018356
Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly
A Phase 4 study testing exercise and testosterone in people with Muscle Weakness and Muscular Atrophy, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Muscle Weakness, Muscular Atrophy
- What is being tested?
- exercise and testosterone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Aug 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, 72114-1706
About this study
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.
- Conditions
- Muscle Weakness, Muscular Atrophy
- Being tested
- exercise, testosterone
- Keywords
- Aging, nutrition, rehabilitation
- Medical subject headings
- Muscle Weakness, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseProcedure or surgery
testosteroneDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Procedure: exercise; Drug: testosterone |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2001 (estimated)
- Study startJan 1999
- Primary completionJul 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Dennis Sullivan, MD, Principal investigator, Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00018356
- Sponsor's protocol ID
- AGCG-007-98S
- Status last verified
- Jun 2011
- First submitted
- 3 Jul 2001
- Last updated
- 23 Jun 2011
- Results posted
- No
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. doi: 10.1249/01.mss.0000181840.54860.8b.
PubMed 16260965
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly
- ClinicalTrials.gov ID
- NCT00018356
- Acronym / sponsor ID
- AGCG-007-98S
- Conditions
- Muscle Weakness, Muscular Atrophy
- Keywords
- Aging, nutrition, rehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 1999
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 5 Jul 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: exercise, Drug: testosterone |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise | Procedure or surgery | 1 |
| testosterone | Drug | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Results publication: PubMed 16260965Sullivan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Sullivan, MD principal investigator
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing exercise and testosterone in people with Muscle Weakness and Muscular Atrophy, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00018356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.