NCT03678714

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Sheffield Hallam University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-04-30
• Completion: 2020-05-30
• First posted: 2018-09-20
• Last updated: 2020-10-29

Locations

1 site across 1 country: United Kingdom