- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Birmingham, Reino Unido, B15 2TT
- University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Change in body composition (fat and fat-free mass in kg)
Prazo: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Perceived body shape
Prazo: 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
Prazo: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Fat oxidation rates
Prazo: 4 weeks, 12 weeks and 24 weeks
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4 weeks, 12 weeks and 24 weeks
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Body tone
Prazo: 4 weeks, 12 weeks, 24 weeks
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4 weeks, 12 weeks, 24 weeks
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Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
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Blood-borne markers of metabolic health
Prazo: 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
Prazo: 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
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Bham_CPW_PhysActIntervention
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