- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03677687
Mindfulness for Physical Activity Research Project
26 de febrero de 2019 actualizado por: Kat Schneider, Liverpool John Moores University
Adapting a Mindfulness-based Programme to Facilitate Physical Activity Uptake in Underactive Participants: A Feasibility Study
This study aims to evaluate the feasibility and preliminary effectiveness of a Mindfulness for Physical Activity programme on physical activity outcomes in underactive participants.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
In recent years, mindfulness-based approaches have increasingly been used in mental and physical health interventions.
There appears to be some consensus about the benefits of standard mindfulness courses, such as Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy on stress, anxiety and depression, and other health conditions.
In terms of physical activity, however, evidence for the use of mindfulness training to promote and improve physical activity is scarce and shows conflicting results.
Evidence suggests that mindfulness training may enhance psychological factors related to exercise, such as intrinsic motivation to engage in physical activity, tolerance of physical activity-related discomfort, and physical activity self-regulation, which could potentially enhance physical activity maintenance in the long run.
Tipo de estudio
Intervencionista
Inscripción (Actual)
18
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Liverpool, Reino Unido, L3 5UG
- Liverpool John Moores University Redmonds Building
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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
19 años a 64 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male or female
- 19-64 years old
- Would like to do more physical activity, but find it boring, uncomfortable, or not enjoyable
- Available and willing to attend all sessions and complete all research measures
Exclusion Criteria:
- Physical disability, cardiovascular condition, or any other illnesses or injuries that would prevent from doing physical activity
- Currently engaging in regular physical activity
- Currently taking medication and/or undergoing therapy for a mental health condition
- Have previously completed a mindfulness course
- Currently engaged in a regular meditation practice
- Away or unavailable on Mondays between 17:30 to 19:30pm for 6 weeks starting 1st October and for other assessment dates up to 17th December 2018
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: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Mindfulness for Physical Activity
A 6-week mindfulness programme (2 hours per week) aimed at increasing physical activity in underactive participants.
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The Mindfulness for Physical Activity (MfPA) programme aims to change participants' relationship with physical activity by targeting psychological factors related to physical activity uptake and maintenance.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Intervention feasibility and acceptability
Periodo de tiempo: Up to 14 weeks
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Assessed using qualitative data gained through a focus group.
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Up to 14 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in physical activity acceptance
Periodo de tiempo: Up to 14 weeks
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Measured using the Physical Activity Acceptance Questionnaire (PAAQ).
The PAAQ is a 10-item measure, rated on a seven-point Likert scale, ranging from 1 (never true) to 7 (always true), with higher scores indicating higher tolerance for physical activity-related discomfort.
Subscales include cognitive acceptance (e.g., "If I have the thought 'exercising today won't be enjoyable', it derails me from my exercise plan") and behavioural commitment (e.g., "Even if I have the desire to stop while I am exercising, I can still follow my exercise plan").
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Up to 14 weeks
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Change in self-reported physical activity
Periodo de tiempo: Up to 14 weeks
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Assessed using the International Physical Activity Questionnaire (IPAQ).
The IPAQ is a 7-item measure, giving a result in multiples of resting metabolic rate (MET), with higher MET minute values indicating more physical activity.
It assesses moderate-intensity physical activity, vigorous-intensity physical activity, walking, and sitting.
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Up to 14 weeks
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Change in objectively measured physical activity
Periodo de tiempo: Up to 14 weeks
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Assessed using accelerometers.
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Up to 14 weeks
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Change in physical activity motivation
Periodo de tiempo: Up to 14 weeks
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Measured using the Behavioural Regulation in Exercise Questionnaire (BREQ-3).
The BREQ-3 is a 24-item measure, rated on a five-point Likert scale, ranging from 0 (not true for me) to 4 (very true for me), with higher scores indicating higher levels of motivation.
Subscales include amotivation (e.g., "I don't see why I should have to exercise"), external motivation (e.g., "I exercise because other people say I should"), introjected motivation (e.g., "I feel guilty when I don't exercise"), identified motivation (e.g., "It's important to me to exercise regularly"), integrated motivation (e.g., "I exercise because it is consistent with my life goals"), and intrinsic motivation (e.g., "I exercise because it's fun").
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Up to 14 weeks
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Change in self-regulation
Periodo de tiempo: Up to 14 weeks
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Measured using the Brief Self-Control Scale (BSCS).
The BSCS is a 13-item measure, rated on a five-point Likert scale, ranging from 1 (not at all like me) to 5 (very much like me), with higher scores indicating higher levels of self-control.
Subscales include inhibition (e.g., "I am good at resisting temptation") and initiation (e.g., "I am able to work effectively toward long-term goals").
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Up to 14 weeks
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Change in dispositional mindfulness
Periodo de tiempo: Up to 14 weeks
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Measured using the Five Facet Mindfulness Questionnaire (FFMQ).
The FFMQ is a 15-item measure, rated on a five-point Likert Scale, ranging from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating higher levels of dispositional mindfulness.
Subscales include acting with awareness (e.g., "When I do things, my mind wanders off and I'm easily distracted"), non-judging (e.g., "I criticize myself for having irrational or inappropriate emotions"), and non-reactivity (e.g., "I perceive my feelings and emotions without having to react to them").
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Up to 14 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
17 de septiembre de 2018
Finalización primaria (Actual)
5 de noviembre de 2018
Finalización del estudio (Actual)
17 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
17 de septiembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
17 de septiembre de 2018
Publicado por primera vez (Actual)
19 de septiembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de febrero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
26 de febrero de 2019
Última verificación
1 de febrero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- MfPA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
Ensayos clínicos sobre Mindfulness for Physical Activity
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