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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
37
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.
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.
Centre for Sports and Exercise Science, Sheffield Hallam University
Sheffield, England, United Kingdom
Recruitment rate
Recruitment rate will be calculated by dividing the number of women eligible and consenting by the recruitment period.
Time frame: One year
Attrition Rate
Attrition rates will be established as discontinuation of the intervention and loss to follow-up measurement for both conditions.
Time frame: 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
Time frame: 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.
Time frame: One year
Oxidised low-density lipoprotein mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Time frame: Baseline and 12-weeks
Free testosterone mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Time frame: Baseline and 12-weeks
Fasting insulin mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Time frame: Baseline and 12-weeks
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C-reactive protein mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Time frame: 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
Time frame: Baseline and 12-weeks
Neopterin mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 12-weeks
Triglycerides mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Time frame: Baseline and 12-weeks
Total cholesterol mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Time frame: Baseline and 12-weeks
Fasting glucose mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Time frame: Baseline and 12-weeks