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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| supervised exercise | Other | It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month. |
|
| Standard of Care | No Intervention | Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised exercise Program | Other | Supervised exercise Program consist of six months of supervised, intermittent track walking. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month. During each exercise session, individuals will be encouraged to walk at a speed of approximately 2 mph until they achieve leg pain or discomfort on walking of moderate severity.Individuals are then allowed to have a brief period of standing or sitting rest to permit symptoms to resolve before they resume exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of an Exercise Intervention on Walking Ability (Functional 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 promoters (LHPs) will walk directly behind the individuals and give standardized instructions of encouragement at set intervals. Data will be reported on meters walked. | 6 months |
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Inclusion Criteria:
Cross-Sectional phase:
Randomization phase:
Exclusion Criteria:
Cross-Sectional Phase
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| Name | Affiliation | Role |
|---|---|---|
| Carlos H Timaran, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
Patients that denied to be randomized and/or to follow the schedule for the research procedures was excluded of the study.
Patients were recruited at community centers. Enrollment was performed between february 2008 and June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Supervised Exercise | It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month. |
| FG001 | Standard of Care | Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cross Sectional Phase |
| |||||||||||||
| Randomization Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Supervised Exercise | It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effect of an Exercise Intervention on Walking Ability (Functional 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 promoters (LHPs) will walk directly behind the individuals and give standardized instructions of encouragement at set intervals. Data will be reported on meters walked. | Posted | Mean | Standard Deviation | meters | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supervised Exercise | It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders |
|
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This study was limited by the lack of patients compliance to follow the schedule for the exercise sessions. Patients did not assisted regularly to the walking sessions, and the schedule was completed in 70 % of the plan.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carlos H Timaran | UT Southwestern Medical Center | 2146450533 | timaran1@msn.com |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
| NOT COMPLETED |
|
| BG001 | Standard of Care | Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care | Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home. |
|
|
| 1 |
| 30 |
| 0 |
| 30 |
| EG001 | Standard of Care | Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home. | 0 | 24 | 0 | 24 |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |