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NCT01440634 · ClinicalTrials.gov registry record · NA
Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 347
- Enrollment target
NCT01440634: Completed NA study, sponsored by University of Texas Southwestern Medical Center.
NCT01440634 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 347 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01440634, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 347 participants
- Enrollment target
Study Summary
Peripheral Arterial Disease (PAD) is a highly prevalent public health problem that results from progressive atherosclerosis of arteries in the lower extremities. PAD is also associated with major detrimental effects on quality of life and functional status, and is the most important cause of limb amputation. More importantly, PAD is a major manifestation of cardiovascular disease and a potent predictor of myocardial infarction, stroke and death. Despite its frequent occurrence, little is known about the natural history of PAD in Hispanics who represent 12.5% of the United States. Because access to health care is limited among Hispanics, CBPR is the ideal process to reach this target population. The goal of the proposed study is to evaluate community-based strategies of detection and treatment of peripheral arterial disease (PAD) in Hispanics. The proposed project consists of two phases: a cross-sectional phase (PAD detection), followed by a randomization phase.During the PAD detection study , the prevalence and severity of PAD in this population will be determined. Specific risk factors associated with PAD among the Hispanic participants will be identified. During the second phase patients will be enrolled in a randomized, non-blinded trial comparing a community-based risk factor modification and supervised exercise program versus usual care for PAD. These individuals will undergo a baseline evaluation similar to the one obtained during the first phase of the study, but will also include functional testing of the lower extremities.
Primary Outcome
Walking distance (Six-Minute Walk test). Following a standardized protocol, individuals are instructed to walk back and forth a 100-ft hallway as far as they can in six minutes after instructions to cover as much distance as possible. A research assistant walks slightly behind each participant so as not to pace the individual. The research assistant records whether or not each person stops during the 6-minute walk. During the proposed study, members of the research team and trained lay health pr
Interventions
- OTHER Supervised exercise Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-02 |
| Phase | NA |
What the finished NCT01440634 record still lists
NCT01440634 is an interventional study that assigns participants to a tested intervention. The registered 347 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Supervised exercise Program is the first listed.
NCT01440634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01440634 about?
NCT01440634 is a clinical study titled "Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.". Peripheral Arterial Disease (PAD) is a highly prevalent public health problem that results from progressive atherosclerosis of arteries in the lower extremities. PAD is also associated with major detrimental effects on quality of life and functional status, and is the most important cause of limb am...
What is the current status of trial NCT01440634?
This trial is currently completed. It is a NA study. The enrollment target is 347 participants. The study started on 2008-02. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01440634?
The interventions under investigation include: Supervised exercise Program (OTHER).
Who is sponsoring clinical trial NCT01440634?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01440634's enrollment target sits among peer trials
347 302nd of 2000 higher than 1,699 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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