Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.
30 de noviembre de 2015 actualizado por: Carlos H Timaran, University of Texas Southwestern Medical Center
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
347
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Texas
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
70 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
Cross-Sectional phase:
- Hispanic men and women aged 70 years or older.
- Hispanic participants with diabetes mellitus or smokers aged 50 through 69 years.
- Individual has been informed of the nature, procedures and risks of the study, and has signed a consent form approved by UT Southwestern Institutional Review Board.
Randomization phase:
- Hispanic men and women aged 70 years or older
- English or Spanish speaking
- Hispanic participants with diabetes mellitus or smokers aged 50 through 69 years.
- Documented peripheral arterial disease with an Ankle-brachial index (ABI) < 0.9 or Toe-brachial index (TBI) <0.7, and abnormal Pulse Volume Recordings (PVR).
- Ability to ambulate independently.
- No prior amputations other than toe or partial foot amputations that do not impede walking.
- Patient has been informed of the nature, procedures and risks of the study, and has signed a consent form approved by the UT Southwestern Institutional Review Board.
Exclusion Criteria:
Cross-Sectional Phase
- Individuals with severe dementia.
- Individuals with inability to provide informed consent.
- Bilateral lower or upper extremities amputations.
- Pregnancy or lactation. Randomization Phase
- Non-ambulatory
- Individuals with prior below- or above-knee amputations
- Individuals unable to give informed consent
- Individuals unwilling to perform the functional tests or quality of life assessments
- Individuals unable to perform exercise therapy, functional tests or quality of life assessments due to severe comorbidities
- Presence of concurrent illness with an anticipated life expectancy less than six months
- Individuals with planned operative interventions
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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.
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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.
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Sin intervención: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Effect of an Exercise Intervention on Walking Ability (Functional Outcome)
Periodo de tiempo: 6 months
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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.
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6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Carlos H Timaran, MD, UT Southwestern Medical Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2008
Finalización primaria (Actual)
1 de febrero de 2013
Finalización del estudio (Actual)
1 de febrero de 2013
Fechas de registro del estudio
Enviado por primera vez
22 de septiembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
23 de septiembre de 2011
Publicado por primera vez (Estimar)
26 de septiembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
29 de diciembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
30 de noviembre de 2015
Última verificación
1 de noviembre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0830128N
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .