- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02020239
The Effect of Physical Activity Intervention Flexibility on the Time Course of Changes in Body Composition and Metabolism
The investigators goal is to optimise physical activity interventions to help previously inactive women improve their body shape and composition. Many people seeking to lose weight or improve body composition initiate an exercise programme. The most common recommendation of an exercise intervention for someone attempting to manage their weight, has been to 'prescribe' the recommended 150 minutes of exercise per week (World Health Organisation), often using one mode of exercise. An alternative approach might be to offer a portfolio of activities, from which the exerciser can pick and choose, to facilitate greater amounts of physical activity. The problem with this is how do you account for the different intensities of walking, washing the car, playing badminton, cycling, jogging, etc? In this study, the investigators will try to overcome this barrier by allocating a number of "physical activity points" to each activity. Using this physical activity points system, participants will be provided with a points target that they can meet using any combination of activities.
The investigators research aim is therefore to compare this points-based system against the traditional 5x30minute prescription (and sedentary control) for their ability to help previously inactive women to drop a dress size, increase fat burning, positively change their body composition and tone their tummy.
Descripción general del estudio
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Birmingham, Reino Unido, B15 2TT
- University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences
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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:
- Female
- Aged 25-50 years old
- Inactive (less than 150 minutes of moderate-intensity aerobic physical activity per week)
- BMI 25-35 kg/m2
- Good general health, as assessed by the School of Sport, Exercise and Rehabilitation Sciences' General Health Questionnaire
- Willing to strictly comply with all study procedures and restrictions
- Willing to participate, as demonstrated by voluntary written informed consent
Exclusion Criteria:
- Positive result from the urine sample pregnancy test
- Currently breast feeding
- Currently participating in another clinical trial deemed to potentially interfere with this study
- Current or recent (within the last 30 days) smoker
- Currently taking prescription or non-prescription medication that may interfere with metabolism (including beta-blockers, insulin, bronchodilators, anti-inflammatory agents, thyroxine and medication/supplements that in the opinion of the investigators may affect metabolism).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Prescribed exercise
Participants will be asked to choose one activity and stick to it for the duration of the intervention.
Participants will be able to choose between brisk walking/slow jogging or cycling.
The intervention will require the completion of 30 minutes of chosen activity on 5 days of the week, which will be recorded in a physical activity diary.
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Experimental: Points-based physical activity
Participants will be asked to achieve a pre-set, individualised points target for physical activity each week.
Points are acquired through the completion of a minimum 10 minutes of activity, choosing from the extensive list of activities provided; for example, 10 minutes of jogging achieves 4.5 points, whereas 10 minutes of washing a car achieves 1.5 points.
The target will be 35-40 points per week, which equates to approximately 6 points per day.
Any combination of activity, duration and frequency can be selected.
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Sin intervención: Waiting list control
Participants will be asked to maintain their normal activities and diet.
They will be added to a waiting list to receive either exercise intervention after completing the 24-week trial period, so that they do not miss out on the opportunity to receive the exercise intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in body composition (fat and fat-free mass in kg)
Periodo de tiempo: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Perceived body shape
Periodo de tiempo: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Maximal aerobic capacity
Periodo de tiempo: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Fat oxidation rates
Periodo de tiempo: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Body tone
Periodo de tiempo: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
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Blood-borne markers of metabolic health
Periodo de tiempo: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Psychological measures relating to perceived body image
Periodo de tiempo: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Psychological measures of attitudes towards exercise and physical activity
Periodo de tiempo: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Bham_CPW_PhysActIntervention
Información sobre medicamentos y dispositivos, documentos del estudio
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