- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02507869
A Trial of an Affect-Guided Physical Activity Prescription
23 de julio de 2015 actualizado por: Austin Baldwin, Southern Methodist University
A Pilot Randomized Controlled Trial of an Affect-Guided Physical Activity
Despite awareness of the benefits of engaging in regular physical activity, at least 50% of adults in the US do not meet recommended guidelines for physical activity.
One potential explanation for this lack of regular physical activity is that people often experience exercise as affectively unpleasant.
Evidence suggests that the more positively people experience exercise (i.e., the better they feel while exercising), the more likely they are to engage in regular physical activity.
This may be especially true for people in poor cardiorespiratory condition.
In this randomized trial, investigators compared the effects of an affect-guided exercise prescription (intervention) to a heart rate-guided exercise prescription (control) on change in physical activity minutes among previously underactive adults.
Investigators also tested whether the effect of the intervention was moderated by differences in cardiorespiratory fitness.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Regular physical activity has many benefits for overall health and well-being, and current public health guidelines recommend at least 150 minutes per week of moderate-to-vigorous intensity activity to attain these benefits.
Despite the many benefits of regular activity, the majority of adults in the US fail to meet recommendations for regular physical activity.
One potential explanation for suboptimal levels of physical activity is that exercise is often experienced as affectively unpleasant.
Recent work has demonstrated that the more positive people feel during exercise, the more likely they are to engage in regular physical activity.
Affective response to exercise is modulated by the intensity of the activity: at a vigorous intensity, affective response is almost uniformly negative and unpleasant, whereas at a moderate intensity, there is more inter-individual variability in affective response.
Whether the intensity of the exercise is self-selected or imposed also influences the affective response to exercise, with self-selected intensities being experienced as more pleasant.
Current recommendations for engaging in physical activity focus on the type of training intensities most likely to result in a negative affective response.
The purpose of this pilot trial was to test the effects of an exercise prescription focused on the maintenance of positive affect during exercise.
Investigators randomized participants to one of two exercise prescription conditions: (1) an affect-guided prescription focused on maintaining a positive affective response (intervention), and (2) a heart rate-guided prescription focused on maintaining a moderate intensity (control).
Investigators tested the effects of these two exercise prescriptions on changes in subsequent physical activity after one week and one month among a sample of underactive adults.
Investigators also tested whether the effect of the intervention was moderated by differences in cardiorespiratory fitness.
Tipo de estudio
Intervencionista
Inscripción (Actual)
67
Fase
- No aplica
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
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Physically underactive individuals (< 60 minutes of physical activity/week).
Exclusion Criteria:
- Presence of cardiovascular disease, pulmonary disease, or hypertension.
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Affect-Guided Prescription
Intervention: Participants in the affect-guided condition are instructed to exercise while monitoring how they feel, and to adjust the intensity of their exercise to maintain a pleasant affective response.
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Participants adjust the intensity of their exercise to maintain a pleasant affective response.
|
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Comparador activo: Heart Rate-Guided Prescription
Intervention: Participants in the heart rate-guided condition are instructed to exercise while monitoring their heart rate, and to adjust the intensity of the exercise to maintain a heart rate in the moderate range (64-76% of their HRmax).
|
Participants adjust the intensity of the exercise to maintain a heart rate in the moderate range (64-76% of their HRmax).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in physical activity minutes measured by the 7-day PAR
Periodo de tiempo: One week
|
One week
|
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Change in physical activity minutes measured by the 7-day PAR
Periodo de tiempo: One month
|
One month
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Austin Baldwin, Ph.D., Southern Methodist University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Ekkekakis P, Lind E. Exercise does not feel the same when you are overweight: the impact of self-selected and imposed intensity on affect and exertion. Int J Obes (Lond). 2006 Apr;30(4):652-60. doi: 10.1038/sj.ijo.0803052.
- Ekkekakis P, Parfitt G, Petruzzello SJ. The pleasure and displeasure people feel when they exercise at different intensities: decennial update and progress towards a tripartite rationale for exercise intensity prescription. Sports Med. 2011 Aug 1;41(8):641-71. doi: 10.2165/11590680-000000000-00000.
- Williams DM, Dunsiger S, Miranda R Jr, Gwaltney CJ, Emerson JA, Monti PM, Parisi AF. Recommending self-paced exercise among overweight and obese adults: a randomized pilot study. Ann Behav Med. 2015 Apr;49(2):280-5. doi: 10.1007/s12160-014-9642-7.
- Ekkekakis P, Lind E, Vazou S. Affective responses to increasing levels of exercise intensity in normal-weight, overweight, and obese middle-aged women. Obesity (Silver Spring). 2010 Jan;18(1):79-85. doi: 10.1038/oby.2009.204. Epub 2009 Jun 25.
- Parfitt G, Alrumh A, Rowlands AV. Affect-regulated exercise intensity: does training at an intensity that feels 'good' improve physical health? J Sci Med Sport. 2012 Nov;15(6):548-53. doi: 10.1016/j.jsams.2012.01.005. Epub 2012 May 31.
- Williams DM, Dunsiger S, Jennings EG, Marcus BH. Does affective valence during and immediately following a 10-min walk predict concurrent and future physical activity? Ann Behav Med. 2012 Aug;44(1):43-51. doi: 10.1007/s12160-012-9362-9.
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 abril de 2013
Finalización primaria (Actual)
1 de abril de 2014
Finalización del estudio (Actual)
1 de abril de 2014
Fechas de registro del estudio
Enviado por primera vez
22 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
23 de julio de 2015
Publicado por primera vez (Estimar)
24 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de julio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
23 de julio de 2015
Última verificación
1 de julio de 2015
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2012-098-SMIJ
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. .