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Not yet recruiting NCT07659392

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

No phase Interventional Poly Cystic Ovary Syndrome Overweight , Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical activity.
Who it may be relevant to
Registry conditions: Poly Cystic Ovary Syndrome, Overweight , Obesity. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Lipid oxidation during walking exercise [Time frame: Baseline and after 10 weeks of intervention]
Secondary outcome measures (12)
  • Energy expenditure at rest [Time frame: Baseline and after 10 weeks of intervention]
  • Lipid oxidation at rest [Time frame: Baseline and after 10 weeks of intervention]
  • Carbohydrate oxidation at rest [Time frame: Baseline and after 10 weeks of intervention]
  • Systolic blood pressure at rest [Time frame: Baseline and after 10 weeks of intervention]
  • Diastolic blood pressure at rest [Time frame: Baseline and after 10 weeks of intervention]
  • Heart rate at rest [Time frame: Baseline and after 10 weeks of intervention]
  • Energy expenditure during walking exercise [Time frame: Baseline and after 10 weeks of intervention]
  • Energy cost of walking [Time frame: Baseline and after 10 weeks of intervention]
  • Carbohydrate oxidation during walking exercise [Time frame: Baseline and after 10 weeks of intervention]
  • Heart rate during walking exercise [Time frame: Baseline and after 10 weeks of intervention]
  • Fat mass [Time frame: Baseline and after 10 weeks of intervention]
  • Fat-free mass [Time frame: Baseline and after 10 weeks of intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CHU de Clermont-Ferrand — Clermont-Ferrand

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗