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- Ensaio Clínico NCT02175810
Impact of Bariatric Surgery on Cardiorespiratory Function
Impact of Bariatric Surgery on Cardiorespiratory Function: an Observational Study
Obesity is a growing problem worldwide and its prevention has become one of the leading priorities for the World Health Organisation. Obesity results from chronic imbalance between energy intake and energy expenditure. Although early prevention of obesity is preferable, surgical treatment is often required for severely obese people.
Bariatric surgery has been shown to be the most effective therapy for severe obesity. Weight loss following bariatric surgery results in significant improvements in coexisting comorbidities, such as diabetes and hypertension but there is controversy whether bariatric surgery also improves aerobic capacity.
The purpose of this study is to investigate the effects of bariatric surgery on cardiopulmonary function and on daily physical activity. It is hypothesized that bariatric surgery will improve aerobic capacity and result in beneficial lifestyle changes from sedentary to more active.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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London, Reino Unido, SW17 0RE
- Recrutamento
- St George's Healthcare NHS Trust
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Contato:
- Dimitra Nikoletou
- Número de telefone: +44 20 8725 5647
- E-mail: dinikole@sgul.ac.uk
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Subinvestigador:
- Emma R McGlone
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Subinvestigador:
- Ommar A Khan
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Ages 18 years to 50 years
- Patients enrolled in the bariatric surgery program of St George's Hospital with BMI > 40 kg/m2, or 35-40 kg/m2 in the presence of other obesity-related comorbidities such as hypertension or type- 2 diabetes
Exclusion Criteria:
- Locomotor difficulties which would prevent participants from completing the cardiopulmonary exercise testing
- Weight > 190 kg (due to weight restrictions of equipment used to transfer patients in the event of medical emergencies)
- Cognitive impairment
- Patients unable to follow instructions in English
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Cardiorespiratory function assessed by peak oxygen consumption (VO2peak)
Prazo: One to two weeks before surgery and six months after surgery
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One to two weeks before surgery and six months after surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Lung function
Prazo: One to two weeks before surgery and six months after surgery
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Lung function will be assessed by spirometry and body plethysmography
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One to two weeks before surgery and six months after surgery
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Heart function
Prazo: One to two weeks before surgery and six months after surgery
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Echocardiography will be performed to assess heart function.
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One to two weeks before surgery and six months after surgery
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Inspiratory muscle strength
Prazo: One to two weeks before surgery and six months after surgery
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Maximal inspiratory pressure and sniff nasal pressure will be recorded.
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One to two weeks before surgery and six months after surgery
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Peripheral muscle strength
Prazo: One to two weeks before surgery and six months after surgery
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Maximum isometric strength of hand/ forearm, quadriceps and hip flexors muscles will be evaluated
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One to two weeks before surgery and six months after surgery
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Free living sedentary and physical activity times
Prazo: One to two weeks before surgery and six months after surgery
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Daily physical activity habits will be assessed by an accelerometer and International Physical Activity Questionnaire: Long (IPAQ-Long).
Participants will be required to wear the accelerometer for four consecutive days during the two study points.
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One to two weeks before surgery and six months after surgery
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Marcia S Volpe, Universidade Federal Triangulo Mineiro
- Cadeira de estudo: Dimitra Nikoletou, Kingston University and St George's University of London
- Diretor de estudo: Marcus Reddy, St George's Healthcare NHS Trust
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 13.0217
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