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- Ensayo clínico NCT00910507
The Impact of Exercise Counseling on Exercise Behavior in People With Type 2 Diabetes: A Randomized Clinical Trial
The Impact of Physical Therapist-Directed Exercise Counseling Combined With Fitness Center-Based Exercise Training on Stage of Exercise Behavior in People With Type 2 Diabetes: A Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Type 2 diabetes is a chronic, metabolic disease characterized by hyperglycemia resulting from insulin resistance. Research studies indicate that complications such as cardiovascular disease, peripheral vascular disease, retinopathy, and loss of physical function are associated with type 2 diabetes. Clinical management of people with type 2 diabetes consists of medical nutrition therapy, pharmacological therapy, and exercise. Exercise has been shown to improve risk factors associated with complications of type 2 diabetes such as elevated plasma glucose, elevated blood pressure, loss of muscular strength, and loss of exercise capacity. In fact, the American Diabetes Association and American College of Sports Medicine have published position statements recommending the use of exercise, specifically resistance and aerobic training, as an intervention for people with type 2 diabetes. However, 31 percent of people with type 2 diabetes have reported no regular physical activity and an additional 38 percent have reported less than recommended levels of physical activity. Therefore, interventions to promote regular exercise behavior in people with type 2 diabetes are clinically important by potentially preventing type 2 diabetes-related complications.
Previous studies have investigated the impact of exercise counseling on exercise behavior in people with type 2 diabetes. However, these studies have limitations such as lack of agreement with exercise training guidelines for people with type 2 diabetes and research design flaws. This current study investigates the effect of a novel, physical therapist-directed exercise counseling combined with fitness center-based exercise training intervention on stage of exercise behavior in people with type 2 diabetes.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Arkansas
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Conway, Arkansas, Estados Unidos, 72035
- University of Central Arkansas
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Type 2 diabetes
- Consider medically stable to participate by a physician
Exclusion Criteria:
- Contraindication for exercise testing
- Uncontrolled hypertension
- Proliferative retinopathy
- Severe peripheral neuropathy
- Nephropathy
- Autonomic neuropathy
- Unable to participate due to a physical impairment
- Fasting plasma glucose greater than 250 mg/dL
- Involved in resistance or aerobic training on 2 or more days per week
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Exercise counseling
Each participant in the experimental group receives exercise counseling from the same physical therapist as described in previous research.
In short, during each exercise counseling session, the physical therapist addresses the benefits of exercise for people with type 2 diabetes, advises each participant to adhere to the prescribed exercise program, and assists each participant by reviewing the prescribed exercise program.
Exercise counseling is tailored to the stage of exercise behavior as described in previous literature.
The experimental group is also provided access to a fitness center.
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Each participant in the experimental group receives 2 months of exercise counseling from the same physical therapist as described in previous research.
In short, during each exercise counseling session, the physical therapist addresses the benefits of exercise for people with type 2 diabetes, advises each participant to adhere to the prescribed exercise program, and assists each participant by reviewing the prescribed exercise program.
Exercise counseling is tailored to the stage of exercise behavior as described in previous literature.
The experimental group is also provided access to a fitness center.
|
|
Comparador activo: Supervised exercise training
Participants who are randomly allocated to the comparison group receive a 2-month supervised exercise program.
Each participant in the comparison group receives the same prescribed exercise program as the experimental group and is supervised during each exercise training session by a trained co-investigator in a controlled exercise laboratory setting.
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Participants who are randomly allocated to the comparison group receive a 2-month supervised exercise program.
Each participant in the comparison group receives the same prescribed exercise program as the experimental group and is supervised during each exercise training session by a trained co-investigator in a controlled exercise laboratory setting.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Stage of Exercise Behavior
Periodo de tiempo: 2 months
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2 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: James D Taylor, PT, PhD, University of Central Arkansas
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UCA IRB 07-070
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