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Physical Activity and Cardiometabolic Health in Women With or Without Polycystic Ovary Syndrome (SCOPAP) (SCOPAP)

16 de junho de 2026 atualizado por: University Hospital, Clermont-Ferrand

Cardiometabolic Health in Women With Overweight or Obesity, With or Without Polycystic Ovary Syndrome: Effects of a Targeted Adapted Physical Activity Program

The primary objective of this study is to investigate the effects of a multidisciplinary intervention, including a targeted adapted physical activity program, on lipid oxidation during a walking exercise in women with overweight or obesity, with or without polycystic ovary syndrome. Specifically, the study aims to compare changes in lipid oxidation before and after the intervention between women with polycystic ovary syndrome and those without polycystic ovary syndrome.

The secondary objectives are to assess the impact of polycystic ovary syndrome on several physiological and metabolic parameters in women with overweight or obesity. These include: (i) resting energy metabolism; (ii) resting blood pressure and heart rate; (iii) energy expenditure, energy cost, and heart rate during a walking exercise; (iv) body composition, glycemic and lipid profiles, and circulating levels of sex hormones and adipokines; (v) movement behaviors; and (vi) physical fitness.

In addition, the effect of the multidisciplinary intervention, including the adapted physical activity program, will be evaluated on these same outcomes: (i) resting energy metabolism; (ii) resting blood pressure and heart rate; (iii) energy expenditure, energy cost, and heart rate during walking exercise; (iv) body composition, glycemic and lipid profiles, and concentrations of sex hormones and adipokines; (v) movement behaviors; and (vi) physical fitness, in women with overweight or obesity, with or without polycystic ovary syndrome.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Women aged 18 to 40 years (inclusive boundaries)
  • Women with a body mass index (BMI) between 25 and 40 kg/m²
  • Women performing no more than 150 minutes of moderate-to-vigorous physical activity per week
  • Women able to provide informed consent to participate
  • Women affiliated with a social security system
  • One group will consist of women with polycystic ovary syndrome, and another group will consist of women without polycystic ovary syndrome

Exclusion Criteria:

  • Pregnancy or breastfeeding, as declared by the participant
  • Postmenopausal women
  • Women currently receiving pharmacological treatment for obesity or who have received such treatment within the past two years
  • Women under legal protection measures (guardianship, curatorship, or judicial protection)
  • Refusal to sign the informed consent form

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Ciência básica
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervenção de atividade física
Comportamental: Physical activity
Participants will participate to adapted physical activity, supervised by a professional

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Lipid oxidation during walking exercise
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention

Medidas de resultados secundários

Medida de resultado
Prazo
Energy expenditure at rest
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Lipid oxidation at rest
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Carbohydrate oxidation at rest
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Systolic blood pressure at rest
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Diastolic blood pressure at rest
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Heart rate at rest
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Energy expenditure during walking exercise
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Energy cost of walking
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Carbohydrate oxidation during walking exercise
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Heart rate during walking exercise
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Fat mass
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Fat-free mass
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Body hydration
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Fasting glycemia
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Fasting insulin concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Fasting triglyceride concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Fasting LDL cholesterol concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Fasting HDL concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Fasting total cholesterol concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Fasting free-fatty acid concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Follicle-stimulating hormone concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Luteinizing hormone concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Estrogen concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Progesterone concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Total testosterone concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Free testosterone concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Fasting leptin concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Fasting adiponectin concentrations
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Time spent in sedentary behaviors
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Time spent in moderate-to-vigorous physical activity
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Physical fitness-minute walking distance
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Right hand grip strength
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Left hand grip strength
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Number of repetitions during the 30-seconde chair stand test
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Herat rate at the end of the step test
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Heart rate 1 minute after the end of the step test
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Heart rate 2 minutes after the end of the step test
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention
Heart rate 3 minutes at the end of the step test
Prazo: Baseline and after 10 weeks of intervention
Baseline and after 10 weeks of intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Clermont-Ferrand

Colaboradores

Laboratoire AME2P
SMR Nutrition Obésité UGECAM

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2028

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

11 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

22 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RBHP 2026 BRUGNON
  • 2026-A00712-49 (Outro identificador: ANSM)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Internal regulation

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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