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

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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Behavioral: Exercise Intervention; Behavioral: Lifestyle Physical Activity

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Sheffield, England, United Kingdom, S10 2BP
      • Centre for Sports and Exercise Science, Sheffield Hallam University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise Intervention; Structured exercise intervention will be undertaken for 12 weeks	Behavioral: Exercise Intervention; 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.
EXPERIMENTAL: Lifestyle Physical Activity; Increased lifestyle physical activity undertaken for 12 weeks	Behavioral: Lifestyle Physical Activity; 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.
NO_INTERVENTION: Control; Resting control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Recruitment rate will be calculated by dividing the number of women eligible and consenting by the recruitment period.	One year
Attrition Rate	Attrition rates will be established as discontinuation of the intervention and loss to follow-up measurement for both conditions.	One year
Compliance to intervention	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	One year
Suitability of allocation and measurement procedures	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.	One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sheffield Hallam University
• Collaborators: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Amie Woodward, MSc, Sheffield Hallam University; Study Director: Markos Klonizakis, PhD, Sheffield Hallam University

Publications and helpful links

General Publications

• Woodward A, Broom D, Dalton C, Metwally M, Klonizakis M. Supervised exercise training and increased physical activity to reduce cardiovascular disease risk in women with polycystic ovary syndrome: study protocol for a randomized controlled feasibility trial. Trials. 2020 Jan 20;21(1):101. doi: 10.1186/s13063-019-3962-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): May 30, 2020

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (ACTUAL): September 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: polycystic ovary syndrome; physical activity; exercise; cardiovascular disease; metabolism; low-density lipoprotein
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: ER6262197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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