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Набор скоро начнётся NCT07659392

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

Без фазы С лечением Poly Cystic Ovary Syndrome Overweight , Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Physical activity.
Кому может быть актуально
Состояния в реестре: Poly Cystic Ovary Syndrome, Overweight , Obesity. Базовые параметры: 18 лет — 40 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое Physical activity
    Participants will participate to adapted physical activity, supervised by a professional

Первичные конечные точки

  • Lipid oxidation during walking exercise [Срок оценки: Baseline and after 10 weeks of intervention]
Вторичные конечные точки (12)
  • Energy expenditure at rest [Срок оценки: Baseline and after 10 weeks of intervention]
  • Lipid oxidation at rest [Срок оценки: Baseline and after 10 weeks of intervention]
  • Carbohydrate oxidation at rest [Срок оценки: Baseline and after 10 weeks of intervention]
  • Systolic blood pressure at rest [Срок оценки: Baseline and after 10 weeks of intervention]
  • Diastolic blood pressure at rest [Срок оценки: Baseline and after 10 weeks of intervention]
  • Heart rate at rest [Срок оценки: Baseline and after 10 weeks of intervention]
  • Energy expenditure during walking exercise [Срок оценки: Baseline and after 10 weeks of intervention]
  • Energy cost of walking [Срок оценки: Baseline and after 10 weeks of intervention]
  • Carbohydrate oxidation during walking exercise [Срок оценки: Baseline and after 10 weeks of intervention]
  • Heart rate during walking exercise [Срок оценки: Baseline and after 10 weeks of intervention]
  • Fat mass [Срок оценки: Baseline and after 10 weeks of intervention]
  • Fat-free mass [Срок оценки: Baseline and after 10 weeks of intervention]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • CHU de Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT07659392 · RBHP 2026 BRUGNON · 2026-A00712-49

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗