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Not yet recruitingNCT07659392SCOPAPUpdated Jun 22, 2026

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

An interventional study of Physical activity in Poly Cystic Ovary Syndrome and Overweight , Obesity, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Poly Cystic Ovary Syndrome
  • Overweight , Obesity

Keywords

  • polycystic ovary syndrome
  • women
  • cardiometabolic
  • Physical activity
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's planned enrollment of 40 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Physical activity intervention

    Behavioral: Physical activity

Interventions

  • BehavioralPhysical activity

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

06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Internal regulation

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07659392
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
SMR Nutrition Obésité UGECAM, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
Responsible party
Sponsor
First posted
Jun 22, 2026
Start date
Jul 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jun 22, 2026

Study contacts

Lise Laclautre
Contact
promo_interne_drci@chu-clermontferrand.fr
+33473754963

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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