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- Ensayo clínico NCT00183014
Caminemos! Trial to Increase Walking Among Sedentary Older Latinos
Trial to Increase Walking Among Sedentary Older Latinos
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Regular physical activity contributes to the health and quality of life of older adults, but unfortunately only 20% of men and 25% of women aged 65 years and greater meet the minimal national guidelines for physical activity. Older Latinos have higher rates of diseases that are most likely to benefit from physical activity, but have disproportionately high rates of sedentary lifestyle. To address this major public health problem, this study will implement and evaluate a multifaceted intervention to raise and sustain walking levels among older Latinos.
A total of 600 sedentary older Latinos will be recruited from community-based senior centers in the greater Los Angeles region. The specific aims of the study are to test the effect of the intervention on:
- the change in steps per week measured by digital pedometer from baseline to 1, 12, and 24-month follow-up;
- self-reported physical activity level and intervening constructs (including expectations regarding aging and self-efficacy expectations for physical activity);
- psychosocial health constructs, physical performance measures, and clinical health outcomes.
The core of the intervention consists of a series of 4 weekly 1-hour group discussion sessions that utilize attribution retraining techniques from the field of motivational psychology in combination with behavioral strategies based in social cognitive theory. Discussion sessions will be conducted at senior centers and led by a bilingual health educator; each session will be followed by a 1-hour exercise class aimed at increasing strength, flexibility and endurance. During the discussion sessions, the health educator will administer a structured culturally-tailored curriculum in which participants are taught to raise their expectations for physical activity with aging and not to attribute being sedentary to "old age." The 4 weekly sessions will be followed by monthly sessions for 11 months, and sessions every 2 months for the following 12 months (total intervention duration = 24 months). Participants will be randomized to 1 of 2 arms:
- intervention arm: receiving the discussion session and the exercise class;
- control arm: receiving just the exercise class with the same frequency and duration as the intervention group.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095
- UCLA Division of Geriatrics
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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:
- Aged 60 years or older
- Self-identifying as Latino/Hispanic
- Not currently participating in 20 minutes or more of physical activity 3 times a week
- Willingness to take brief physical activity screening test and if do not pass, provide the name of a physician who has seen the patient in the recent past
Exclusion Criteria:
- Plans to move from the area in the next 24 months
- Unable to participate in 1-hour group discussion
- Unable to walk
- Physician stating that patient is not medically able to participate
- Family member already participating
- Substantial cognitive impairment (determined by a screening test)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
discussion session and exercise class
|
A series of 4 weekly 1-hour group discussion sessions that utilize attribution retraining techniques from the field of motivational psychology in combination with behavioral strategies based in social cognitive theory; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
1-hour exercise class aimed at increasing strength, flexibility and endurance; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
|
Comparador activo: 2
exercise class only
|
1-hour exercise class aimed at increasing strength, flexibility and endurance; weekly for 4 weeks, monthly for 11 months, then every two months for 12 months (total duration = 24 months
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number of steps per week on digital pedometer
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Self-reported physical activity level
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
beliefs about aging
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
self-efficacy
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
health-related quality of life
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
blood pressure
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
body mass index (BMI)
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
physical performance measures
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
hospital days
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
outpatient visits
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
restricted activity days
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
cognitive function
Periodo de tiempo: baseline and 1, 12, and 24-months
|
baseline and 1, 12, and 24-months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Catherine Sarkisian, MD, MSPH, UCLA Division of Geriatrics
Publicaciones y enlaces útiles
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
Otros números de identificación del estudio
- AG0049
- 5R01AG024460-02 (Subvención/contrato del NIH de EE. UU.)
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. .
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