Effects of Exercise on Oxidised LDL and Cardiometabolic Profile in Women With Polycystic Ovary Syndrome: Study Protocol for a Feasibility Randomized-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sheffield Hallam University
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Recruitment rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
It is not possible to mask participants or research team to the allocated intervention. Outcome assessors will be blinded to group allocation for anthropometric and fitness measures.
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Recruitment rate
Time Frame: One year
Recruitment rate will be calculated by dividing the number of women eligible and consenting by the recruitment period.
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
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.
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.
Secondary Outcomes
- Sex hormone binding globulin mean change from baseline(Baseline and 12-weeks)
- Oxidised low-density lipoprotein mean change from baseline(Baseline and 12-weeks)
- Free testosterone mean change from baseline(Baseline and 12-weeks)
- Fasting glucose mean change from baseline(Baseline and 12-weeks)
- Thiobarbituric Acid and Reactive Substances (TBARS) mean change from baseline(Baseline and 12-weeks)
- Neopterin mean change from baseline(Baseline and 12-weeks)
- Low density lipoprotein cholesterol mean change from baseline(Baseline and 12-weeks)
- Total cholesterol mean change from baseline(Baseline and 12-weeks)
- Fasting insulin mean change from baseline(Baseline and 12-weeks)
- C-reactive protein mean change from baseline(Baseline and 12-weeks)
- Triglycerides mean change from baseline(Baseline and 12-weeks)
- High density lipoprotein cholesterol mean change from baseline(Baseline and 12-weeks)