- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00747019
Prosocial Behavior and Exercise Among Older Adults
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Although only a small percentage of older adults engage in habitual physical activity, previous studies have demonstrated interventions that include cognitive-behavioral strategies can enhance long-term, independent physical activity. In addition, there are episodic charity events, such as charity walks, that attract large numbers of participants of all age ranges to engage in moderate-intensity physical activity. These actions are a form of prosocial behavior, defined as voluntary, intentional behavior that results in benefits for another. The opportunity to help others seems to be a motive in inspiring these individuals to at least engage in one session of moderate physical activity. Thus, the current research project contemplates whether prosocial behavior may be implemented as a viable behavioral incentive for long-term physical activity.
Both the Prosocial Behavior Physical Activity (PBPA) group and the Physical Exercise (PE) group will receive a cognitive-behavioral intervention to teach participants the behavioral skills necessary to engage in long-term (9-month) independent physical activity. Both programs will provide supervised exercise sessions so that participants learn how to safely and effectively engage in physical activity, and both programs will help participants set goals for activity and overcome barriers to exercise. However, in PBPA group, participants will be able to also earn boxes of food for donation to a charity based upon their physical activity.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27127
- Reclutamiento
- Wake Forest University School of Medicine
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Contacto:
- Susan J. Harris
- Número de teléfono: 336-713-4244
- Correo electrónico: sjharris@wfubmc.edu
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Contacto:
- Carol Massa-Fanale
- Número de teléfono: 336-716-3589
- Correo electrónico: cmassa@wfubmc.edu
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Investigador principal:
- Capri G. Foy, PhD, MS
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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:
- Between 55 and 80 years of age
- Physically underactive (moderate or vigorous physical activity for less than 2 days per week for the preceding 3 months)
- No evidence of any major psychological illness
- Written permission from the participant's primary care physician with specific certification of no severe risk of cardiovascular disease
- Participant resides within a 35-mile radius of the study site
- Participant will remain in the area for the duration of the study
Exclusion Criteria:
Self-reported evidence of cardiovascular disease risk, or documentation by the primary care physician of at least one of the following within the past 5 years:
- Myocardial infarction (MI)
- Percutaneous transluminal coronary angioplasty (PTCA)
- Chronic or unstable angina at rest or during physical exertion
- New York Heart Association (NYHA) Type I through Type IV congestive heart failure
- Unstable ventricular arrhythmias
- Cardiovascular surgery (coronary artery or valvular heart disease)
- Ischemic or hemorrhagic stroke
- Intermittent claudication during physical activity
- Edema in feet
- Self-reported or documented evidence of rheumatoid arthritis
- Self-reported or physician-reported evidence of current cigarette or cigar smoking
Self-reported treatment for psychiatric illness within the past 5 years:
- Treatment for major depression or schizophrenia
- Currently receiving lithium or neuroleptics
- Hospitalization with the last 5 years for depression, or clinical judgment of treatment for major depression
- Hearing or sight impairments
- Cognitive impairment
- Alcohol consumption greater than 21 drinks per week, or self-reported alcoholism
- Inability to speak or read English
- Judgment of clinical staff
- Current participation in another medical intervention study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PBPA
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The PBPA condition involves a center-based cognitive-behavioral intervention to teach participants the behavioral skills to engage in long-term (9-month) independent physical activity; delivered three times a week months 1-3; independent physical activity months 4-9.
PBPA participants also earn boxes of food for donation to the Second Harvest Food Bank (SHFB) of Northwest North Carolina based upon their weekly physical activity.
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Comparador activo: PE
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The PE condition is a center-based cognitive-behavioral intervention to teach participants the behavioral skills to engage in long-term (9-month) independent physical activity; delivered three times a week months 1-3; independent physical activity months 4-9.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Self-reported physical activity
Periodo de tiempo: Baseline, 3 and 9 months
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Baseline, 3 and 9 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Physical function, health-related quality of life
Periodo de tiempo: Baseline, 3 and 9 months
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Baseline, 3 and 9 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Capri G. Foy, PhD, MS, Division of Public Health Sciences, Wake Forest University School of Medicine
Publicaciones y enlaces útiles
Publicaciones Generales
- Rejeski WJ, Brawley LR, Ambrosius WT, Brubaker PH, Focht BC, Foy CG, Fox LD. Older adults with chronic disease: benefits of group-mediated counseling in the promotion of physically active lifestyles. Health Psychol. 2003 Jul;22(4):414-23. doi: 10.1037/0278-6133.22.4.414.
- Rejeski WJ, Foy CG, Brawley LR, Brubaker PH, Focht BC, Norris JL 3rd, Smith ML. Older adults in cardiac rehabilitation: a new strategy for enhancing physical function. Med Sci Sports Exerc. 2002 Nov;34(11):1705-13. doi: 10.1097/00005768-200211000-00003.
- Eisenberg N, Miller PA. The relation of empathy to prosocial and related behaviors. Psychol Bull. 1987 Jan;101(1):91-119. No abstract available.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- AG0106
- 1R21AG027413-01A2 (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. .