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

16 de junio de 2026 actualizado 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

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

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

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: Ciencia básica
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervención de actividad física
Conductual: Physical activity
Participants will participate to adapted physical activity, supervised by a professional

¿Qué mide el estudio?

Medidas de resultado primarias

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

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University Hospital, Clermont-Ferrand

Colaboradores

Laboratoire AME2P
SMR Nutrition Obésité UGECAM

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 (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de diciembre de 2028

Finalización del estudio (Estimado)

1 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

11 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Internal regulation

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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