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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Behavioral: Exercise Intervention
* Behavioral: Lifestyle Physical Activity


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomised into either an exercise group, a lifestyle physical activity group, or a control group, for a duration of 12 weeks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Intervention<br>Structured exercise intervention will be undertaken for 12 weeks | Behavioral: Exercise Intervention<br>* 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.<br>|
| Experimental: Lifestyle Physical Activity<br>Increased lifestyle physical activity undertaken for 12 weeks | Behavioral: Lifestyle Physical Activity<br>* 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.<br>|
| No Intervention: Control<br>Resting control | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polycystic ovary syndrome, exercise, physical activity, cardiovascular disease, low-density lipoprotein, metabolism