- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02857127
Physical Activity Promotion in Primary Health Care Settings
Promoting Physical Activity for Vulnerable Adults and Elderly People: Evaluation of a Walking Program in Primary Care Settings
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
There is a high prevalence of physical inactivity (AF) in the world and in Brazil. Offering programs of physical activity becomes a convenient option to increase the physical activity level of the population and promote aging process more active and healthy over the life. There is need for greater depth in relation to the operation of programs to promote physical activity and the effects of these programs on different biopsychosocial aspects, especially those offered in primary care settings. This research aims to evaluate a walking program geared to adults and seniors on the following aspects:
- Characteristics and operation of the intervention,
- effects of behavior change to physical activity, and
- biopsychosocial effects of physical activity.
It is a quasi experimental and controlled study, with: 1) intervention group (n = 71), 2) and control group (n = 71). The intervention will last for six months, with a subsequent follow-up period of six months after the intervention. The program will offer supervised exercise twice a week, lasting an hour. The classes will consist of recreational activities, walking and educational strategies of behavior change for physical activity. Variables will be evaluated for attendance, barriers to physical activity, waiver reasons, physical activity level, sociodemographic, socioeconomic and biopsychosocial aspects. Most females, aged over 40 years, low levels of education, income and varied biopsychosocial characteristics are expected. After the intervention, it is expected that the program present characteristics of low adhesion and retention, especially because of the barrier "lack of time". Still, the promotion of supervised walking increase levels of physical activity beyond the time provided by the program and it will improve the biopsychosocial conditions of the participants.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
São Paulo
-
São Carlos, São Paulo, Brasil, 13565-517
- Secretaria Municipal de Saúde
-
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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:
- To be insufficiently active
- To accept the intervention invitation
- Living around the selected primary health care
- To sign the Term os Consent
- To have 18 years or more
Exclusion Criteria:
- To participate only in one day of intervention
- To have less than 75% of presence in the intervention
- To give up of the intervention
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention Group
A group of people who participated in the walking program during a six month period.
This group also received an educational material and attended meetings for behavioral change strategies.
|
To encourage people to exercise more through a behavioural and educational intervention during six months and other six months of follow up.
|
|
Sin intervención: Control Group
A group of people who did not receive the educational material and did not participated in any of the activities offered by the research team, such as walking classes and meetings for behavioral change.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Subjective evaluation of physical activity level evaluated through the International Physical Activity Questionnaire
Periodo de tiempo: six months
|
Physical activity level evaluated through the International Physical Activity Questionnaire
|
six months
|
|
Objective evaluation of physical activity level evaluated through accelerometer device
Periodo de tiempo: six months
|
Physical activity level evaluated through accelerometer device
|
six months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Grace AO Gomes, Doctor, Universidade Federal de São Carlos
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
- FAPESP14/03909-2
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. .