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NCT Number: NCT07659392

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

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.

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Key information

Conditions

Poly Cystic Ovary Syndrome Adnexal Diseases Behavior Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Motor Activity Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Overweight , Obesity Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Signs and Symptoms Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

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

Primary outcomes

  1. Lipid oxidation during walking exercise

    Time frame: Baseline and after 10 weeks of intervention

Secondary outcomes

  1. Energy expenditure at rest

    Time frame: Baseline and after 10 weeks of intervention

  2. Lipid oxidation at rest

    Time frame: Baseline and after 10 weeks of intervention

  3. Carbohydrate oxidation at rest

    Time frame: Baseline and after 10 weeks of intervention

  4. Systolic blood pressure at rest

    Time frame: Baseline and after 10 weeks of intervention

  5. Diastolic blood pressure at rest

    Time frame: Baseline and after 10 weeks of intervention

  6. Heart rate at rest

    Time frame: Baseline and after 10 weeks of intervention

  7. Energy expenditure during walking exercise

    Time frame: Baseline and after 10 weeks of intervention

  8. Energy cost of walking

    Time frame: Baseline and after 10 weeks of intervention

  9. Carbohydrate oxidation during walking exercise

    Time frame: Baseline and after 10 weeks of intervention

  10. Heart rate during walking exercise

    Time frame: Baseline and after 10 weeks of intervention

  11. Fat mass

    Time frame: Baseline and after 10 weeks of intervention

  12. Fat-free mass

    Time frame: Baseline and after 10 weeks of intervention

  13. Body hydration

    Time frame: Baseline and after 10 weeks of intervention

  14. Fasting glycemia

    Time frame: Baseline and after 10 weeks of intervention

  15. Fasting insulin concentrations

    Time frame: Baseline and after 10 weeks of intervention

  16. Fasting triglyceride concentrations

    Time frame: Baseline and after 10 weeks of intervention

  17. Fasting LDL cholesterol concentrations

    Time frame: Baseline and after 10 weeks of intervention

  18. Fasting HDL concentrations

    Time frame: Baseline and after 10 weeks of intervention

  19. Fasting total cholesterol concentrations

    Time frame: Baseline and after 10 weeks of intervention

  20. Fasting free-fatty acid concentrations

    Time frame: Baseline and after 10 weeks of intervention

  21. Follicle-stimulating hormone concentrations

    Time frame: Baseline and after 10 weeks of intervention

  22. Luteinizing hormone concentrations

    Time frame: Baseline and after 10 weeks of intervention

  23. Estrogen concentrations

    Time frame: Baseline and after 10 weeks of intervention

  24. Progesterone concentrations

    Time frame: Baseline and after 10 weeks of intervention

  25. Total testosterone concentrations

    Time frame: Baseline and after 10 weeks of intervention

  26. Free testosterone concentrations

    Time frame: Baseline and after 10 weeks of intervention

  27. Fasting leptin concentrations

    Time frame: Baseline and after 10 weeks of intervention

  28. Fasting adiponectin concentrations

    Time frame: Baseline and after 10 weeks of intervention

  29. Time spent in sedentary behaviors

    Time frame: Baseline and after 10 weeks of intervention

  30. Time spent in moderate-to-vigorous physical activity

    Time frame: Baseline and after 10 weeks of intervention

  31. Physical fitness-minute walking distance

    Time frame: Baseline and after 10 weeks of intervention

  32. Right hand grip strength

    Time frame: Baseline and after 10 weeks of intervention

  33. Left hand grip strength

    Time frame: Baseline and after 10 weeks of intervention

  34. Number of repetitions during the 30-seconde chair stand test

    Time frame: Baseline and after 10 weeks of intervention

  35. Herat rate at the end of the step test

    Time frame: Baseline and after 10 weeks of intervention

  36. Heart rate 1 minute after the end of the step test

    Time frame: Baseline and after 10 weeks of intervention

  37. Heart rate 2 minutes after the end of the step test

    Time frame: Baseline and after 10 weeks of intervention

  38. Heart rate 3 minutes at the end of the step test

    Time frame: Baseline and after 10 weeks of intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Laboratoire AME2P
  • SMR Nutrition Obésité UGECAM

Registry information

Official study title

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

Acronym: SCOPAP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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