The Feasibility of an Active Lifestyle Programme in Patients Recovering From Colorectal Cancer (MOVE)
21 de abril de 2016 actualizado por: University of East Anglia
Feasibility of a Physical Activity Intervention Informed by Self-Determination Theory With Patients Recovering From Colorectal Cancer
Long-term maintenance of physical activity behaviour change post-intervention remains challenging.
This study is investigating the feasibility of a behaviour change intervention based on Self-Determination Theory in people recovering from colorectal cancer and its effects on behaviour change 6 months post-intervention.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study was a randomized controlled feasibility trial consisting of a 3-months active lifestyle intervention and a 3-months follow-up period. Participants were allocated to an active lifestyle programme (ALP) or the standard (SC) care group. ALP was offered 12 supervised exercise sessions over 3 months and six supportive behaviour change workshops. SC was encouraged to continue with their usual lifestyle. The intervention was informed by Self-Determination Theory.
The supervised exercise sessions took place in small groups of maximum 7 participants and lasted approximately 1 hour. Exercise included aerobic and resistance exercises. The behaviour change workshops were delivered in a motivational interviewing style, also in small groups of maximum 7 participants.
Participants were followed-up at 6 months. There was no contact with participants during the post-intervention and follow-up period.
Tipo de estudio
Intervencionista
Inscripción (Actual)
28
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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- a histologically confirmed diagnosis of colorectal cancer with Dukes stages A-C
- completed cancer treatment within the last 24 months,
- be able to understand spoken and written English
- score of 80 or more on the Karnofsky Performance Status Scale
Exclusion Criteria:
- already meeting general PA guidelines of 150 min of moderate PA or 75 min of vigorous intensity PA per week,
- recent myocardial infarction
- uncontrolled hypertension
- a pacemaker
- or unstable angina.
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Active Lifestyle Programme
Supervised exercises for 3 months and motivational interviewing to facilitate physical activity behaviour change.
Supervised exercise sessions took place twice per week for the first four weeks.
This was tapered off to once per week for the second four weeks.
During the last month of the intervention participants continued with the exercise at home and were encouraged to achieve 150min of moderate to vigorous PA per week.
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The intervention is an activity lifestyle programme to increase physical activity behaviour post-intervention and to facilitate behaviour change maintenance at 3 months post-intervention.
Otros nombres:
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Sin intervención: Standard Care
Received usual care.
Was offered the intervention after the completion of the study.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in minutes spent in moderate and vigorous intensity physical activity measure with the International Physical Activity Questionnaire long version
Periodo de tiempo: 0, 3, 6 months
|
0, 3, 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in behavioural regulation measure with the Behavioural Regulation in Exercise Questionnaire version 2
Periodo de tiempo: 0, 3, 6 months
|
0, 3, 6 months
|
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Change in psychological needs satisfaction measured with the psychological needs satisfaction in exercise scale
Periodo de tiempo: 0, 3, 6 months
|
0, 3, 6 months
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Change in quality of life measure with the Functional Assessment of Cancer Therapy general
Periodo de tiempo: 0, 3, 6 months
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0, 3, 6 months
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Change in quality of life measure with the Functional Assessment of Cancer Therapy-colorectal
Periodo de tiempo: 0, 3, 6 months
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0, 3, 6 months
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Change in fatigue with the Functional Assessment of Cancer Therapy - fatigue
Periodo de tiempo: 0, 3, 6 months
|
0, 3, 6 months
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Change in intention to exercise
Periodo de tiempo: 0, 3, 6 months
|
assessed with Intention to exercise scale
|
0, 3, 6 months
|
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Change in barriers to exercise
Periodo de tiempo: 0, 3, 6 months
|
assessed with Barriers to Exercise scale
|
0, 3, 6 months
|
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Change in physical fitness
Periodo de tiempo: 0, 3, and 6 months
|
assessed with the modified Bruce treadmill test
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0, 3, and 6 months
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Change in upper body strength-grip strength
Periodo de tiempo: 0, 3, 6 months
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Assessed with grip dynanometer
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0, 3, 6 months
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Change in upper body strength-upper arm strength
Periodo de tiempo: 0, 3, 6 months
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Assessed with biceps curl test
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0, 3, 6 months
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Change in lower body strength
Periodo de tiempo: 0, 3, 6 months
|
Assessed with 30 sec sit-to-stand test
|
0, 3, 6 months
|
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Changes in body composition (% body fat) assessed with bioelectrical impedance analysis
Periodo de tiempo: 0, 3, 6 months
|
0, 3, 6 months
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Change in antropometric measures (waist circumference, hip circumference
Periodo de tiempo: 0, 3, 6 months
|
Waist and hip circumference will be used to calculate the waist-to-hip ratio
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0, 3, 6 months
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Changes in anthropometric measures (height, weight, BMI)
Periodo de tiempo: 0, 3, 6 months
|
Body weight and body height will be used to calculate BMI
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0, 3, 6 months
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Change in minutes spent in moderate and vigorous intensity physical activity with accelerometry
Periodo de tiempo: 0, 3, 6 months
|
0, 3, 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: John M Saxton, PhD, Northumbria University, Newcastle, United Kingdom
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 octubre de 2013
Finalización primaria (Actual)
1 de septiembre de 2014
Finalización del estudio (Actual)
1 de septiembre de 2014
Fechas de registro del estudio
Enviado por primera vez
21 de abril de 2016
Primero enviado que cumplió con los criterios de control de calidad
21 de abril de 2016
Publicado por primera vez (Estimar)
26 de abril de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
26 de abril de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
21 de abril de 2016
Última verificación
1 de abril de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13/EE/0060
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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