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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Poly Cystic Ovary Syndrome; Overweight , Obesity
• Intervention / Treatment: Behavioral: Physical activity

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: +33473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand
    • Contact: Lise Laclautre; Phone Number: +33473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical activity intervention	Behavioral: Physical activity; Participants will participate to adapted physical activity, supervised by a professional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lipid oxidation during walking exercise	Baseline and after 10 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Energy expenditure at rest	Baseline and after 10 weeks of intervention
Lipid oxidation at rest	Baseline and after 10 weeks of intervention
Carbohydrate oxidation at rest	Baseline and after 10 weeks of intervention
Systolic blood pressure at rest	Baseline and after 10 weeks of intervention
Diastolic blood pressure at rest	Baseline and after 10 weeks of intervention
Heart rate at rest	Baseline and after 10 weeks of intervention
Energy expenditure during walking exercise	Baseline and after 10 weeks of intervention
Energy cost of walking	Baseline and after 10 weeks of intervention
Carbohydrate oxidation during walking exercise	Baseline and after 10 weeks of intervention
Heart rate during walking exercise	Baseline and after 10 weeks of intervention
Fat mass	Baseline and after 10 weeks of intervention
Fat-free mass	Baseline and after 10 weeks of intervention
Body hydration	Baseline and after 10 weeks of intervention
Fasting glycemia	Baseline and after 10 weeks of intervention
Fasting insulin concentrations	Baseline and after 10 weeks of intervention
Fasting triglyceride concentrations	Baseline and after 10 weeks of intervention
Fasting LDL cholesterol concentrations	Baseline and after 10 weeks of intervention
Fasting HDL concentrations	Baseline and after 10 weeks of intervention
Fasting total cholesterol concentrations	Baseline and after 10 weeks of intervention
Fasting free-fatty acid concentrations	Baseline and after 10 weeks of intervention
Follicle-stimulating hormone concentrations	Baseline and after 10 weeks of intervention
Luteinizing hormone concentrations	Baseline and after 10 weeks of intervention
Estrogen concentrations	Baseline and after 10 weeks of intervention
Progesterone concentrations	Baseline and after 10 weeks of intervention
Total testosterone concentrations	Baseline and after 10 weeks of intervention
Free testosterone concentrations	Baseline and after 10 weeks of intervention
Fasting leptin concentrations	Baseline and after 10 weeks of intervention
Fasting adiponectin concentrations	Baseline and after 10 weeks of intervention
Time spent in sedentary behaviors	Baseline and after 10 weeks of intervention
Time spent in moderate-to-vigorous physical activity	Baseline and after 10 weeks of intervention
Physical fitness-minute walking distance	Baseline and after 10 weeks of intervention
Right hand grip strength	Baseline and after 10 weeks of intervention
Left hand grip strength	Baseline and after 10 weeks of intervention
Number of repetitions during the 30-seconde chair stand test	Baseline and after 10 weeks of intervention
Herat rate at the end of the step test	Baseline and after 10 weeks of intervention
Heart rate 1 minute after the end of the step test	Baseline and after 10 weeks of intervention
Heart rate 2 minutes after the end of the step test	Baseline and after 10 weeks of intervention
Heart rate 3 minutes at the end of the step test	Baseline and after 10 weeks of intervention

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Laboratoire AME2P; SMR Nutrition Obésité UGECAM

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: polycystic ovary syndrome; Physical activity; women; cardiometabolic
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Nutrition Disorders; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Overnutrition; Body Weight; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Polycystic Ovary Syndrome; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: RBHP 2026 BRUGNON; 2026-A00712-49 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Internal regulation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No