Effect of Exercise on Cardiometabolic Profile in Women With Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Behavioral: Exercise Intervention; Behavioral: Lifestyle Physical Activity

• Registration Number: NCT03678714
• Lead Sponsor: Sheffield Hallam University

Brief Summary

Polycystic Ovary Syndrome (PCOS) is a complex hormonal and metabolic disorder that has been shown to affect women's fertility. It can also share many symptoms with pre-diabetes, and women with PCOS often have an increased risk for type 2 diabetes, heart attack and stroke.

This study aims to assess the feasibility and acceptability of exercise intervention and increased lifestyle physical activity to improve cardiovascular disease risk factors in women with PCOS.

Detailed Description

This is a three arm feasibility study in which participants will be allocated to an exercise group, an increased lifestyle physical activity group, or a control group. We will determine the appropriateness of procedures for recruitment, allocation, measurement and retention for the intervention procedures in women with polycystic ovary syndrome.

The investigators will also determine if we are able to detect changes in blood lipid profile, inflammation, and hormonal and metabolic profile as a result of the intervention(s) using blood biomarkers.

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-20
• Study Start: 2018-10-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-05-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

• Women diagnosed with PCOS according to the Rotterdam Criteria 2003, National Institute of Health (NIH) 1990 criteria or Androgen Excess and Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.
• Have experienced menarche (their first menstrual bleeding) and be at least 18 years of age.
• Are English speaking.
• Are physically able to perform exercise.

Exclusion Criteria

• Post-menopausal status.
• Are smokers.
• Are undertaking regular structured exercise defined as >150min/week.
• Have been taking metformin for less than three months.
• Are taking the oral contraceptive pill (OCP) or have taken in the last month.
• Have any medical condition that may be responsible for the symptoms of PCOS, such as congenital hyperplasia, androgen-secreting tumour, hyperprolactinemia, or Cushing's syndrome.
• Have current cardiovascular disease or a history of cardiac events.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Intervention	Exercise Intervention	Structured exercise intervention will be undertaken for 12 weeks
Lifestyle Physical Activity	Lifestyle Physical Activity	Increased lifestyle physical activity undertaken for 12 weeks

Primary Outcome Measures

Name	Time	Method
Recruitment rate	One year	Recruitment rate will be calculated by dividing the number of women eligible and consenting by the recruitment period.
Compliance to intervention	One year	Compliance will be monitored by session attendance and monitoring the data from recorded daily physical activity, with examination of reasons for drop-out or non-compliance
Suitability of allocation and measurement procedures	One year	Reasons for drop-out will be used to assess the suitability of allocation procedures. Suitability of measurement procedures will be evaluated by completion rates and reasons for missing data.
Attrition Rate	One year	Attrition rates will be established as discontinuation of the intervention and loss to follow-up measurement for both conditions.

Secondary Outcome Measures

Name	Time	Method
Sex hormone binding globulin mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks
Oxidised low-density lipoprotein mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks
Free testosterone mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks
Fasting glucose mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks
Thiobarbituric Acid and Reactive Substances (TBARS) mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks
Neopterin mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks
Low density lipoprotein cholesterol mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks
Total cholesterol mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks
Fasting insulin mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks
C-reactive protein mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks
Triglycerides mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks
High density lipoprotein cholesterol mean change from baseline	Baseline and 12-weeks	Blood samples are taken from all participants at baseline and after 12 weeks

Trial Locations

Locations (1)

Centre for Sports and Exercise Science, Sheffield Hallam University; 🇬🇧 Sheffield, England, United Kingdom