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NCT01377064 · ClinicalTrials.gov registry record · Phase 1
Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk
A Phase 1 study, sponsored by University of South Carolina.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01377064: Completed Phase 1 study, sponsored by University of South Carolina.
NCT01377064 is a Phase 1 study that has completed, run by University of South Carolina. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01377064, a Phase 1 study, has completed, sponsored by University of South Carolina.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Because of advances in drug treatment, people living with HIV/AIDS (PLWHA) are living longer, but are also at greater risk for cardiovascular disease (CVD) and diabetes. Exercise and increased physical activity can reduce the risk factors for these diseases in PLWHA, but no studies have tested an at-home exercise program that would benefit low income people and others who do not have access to exercise facilities. This study will test the feasibility of an at-home exercise program for PLWHA and prepare for a full-scale intervention study, which may lead to a reduction in CVD risk among PLWHA.
Primary Outcome
Accelerometer data will be the primary means of determining the participants' physical activity levels. Participants will be instructed to wear the accelerometer at baseline, 4 months, and 9 months. The participants will be required to wear the accelerometer during the waking hours for seven consecutive days. Data from participants with at least four days and at least 10 hours per day will be included.
Interventions
- BEHAVIORAL Physical Activity Group
- OTHER Standard Care Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
What the finished NCT01377064 record still lists
NCT01377064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Physical Activity Group is the first listed.
NCT01377064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01377064 about?
NCT01377064 is a clinical study titled "Home-based Exercise for Management of HIV-associated Cardiovascular Disease Risk". Because of advances in drug treatment, people living with HIV/AIDS (PLWHA) are living longer, but are also at greater risk for cardiovascular disease (CVD) and diabetes. Exercise and increased physical activity can reduce the risk factors for these diseases in PLWHA, but no studies have tested an at...
What is the current status of trial NCT01377064?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-03. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01377064?
The interventions under investigation include: Physical Activity Group (BEHAVIORAL), Standard Care Group (OTHER).
Who is sponsoring clinical trial NCT01377064?
This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01377064's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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