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Completed

NCT Number: NCT03678714

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Behavior Cardiovascular Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Motor Activity Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Sports and Exercise Science, Sheffield Hallam University

Sheffield, England, S10 2BP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Exercise Intervention

Behavioral

2 sessions of supervised exercise training each week for 8 consecutive weeks and 3 sessions of supervised exercise training each week for the final 4 consecutive weeks, at 57-74% heart-rate max. Each session will last approximately 60 minutes.

Lifestyle Physical Activity

Behavioral

Advice and information on how to increase physical activity will be provided. Participants will be asked to monitor and track their daily physical activity using a smart-phone fitness application. The research team will gain permission to access their recorded activity.

Primary outcomes

  1. Recruitment rate

    Time frame: One year

    Recruitment rate will be calculated by dividing the number of women eligible and consenting by the recruitment period.

  2. Attrition Rate

    Time frame: One year

    Attrition rates will be established as discontinuation of the intervention and loss to follow-up measurement for both conditions.

  3. Compliance to intervention

    Time frame: 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

  4. Suitability of allocation and measurement procedures

    Time frame: 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.

Secondary outcomes

  1. Oxidised low-density lipoprotein mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

  2. Free testosterone mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

  3. Fasting insulin mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

  4. C-reactive protein mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

  5. Thiobarbituric Acid and Reactive Substances (TBARS) mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

  6. Neopterin mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

  7. Sex hormone binding globulin mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

  8. High density lipoprotein cholesterol mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

  9. Low density lipoprotein cholesterol mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

  10. Triglycerides mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

  11. Total cholesterol mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

  12. Fasting glucose mean change from baseline

    Time frame: Baseline and 12-weeks

    Blood samples are taken from all participants at baseline and after 12 weeks

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

Registry information

Official study title

Effects of Exercise on Oxidised LDL and Cardiometabolic Profile in Women With Polycystic Ovary Syndrome: Study Protocol for a Feasibility Randomized-controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 20, 2018
Registry last updated
Oct 29, 2020

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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