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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03678714
• Other study ID #: ER6262197
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 30, 2020

Study information

• Verified date: October 2020
• Source: Sheffield Hallam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Centre for Sports and Exercise Science, Sheffield Hallam University	Sheffield	England

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Hallam University	Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Recruitment rate will be calculated by dividing the number of women eligible and consenting by the recruitment period.	One year
Primary	Attrition Rate	Attrition rates will be established as discontinuation of the intervention and loss to follow-up measurement for both conditions.	One year
Primary	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
Primary	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	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
Secondary	Free testosterone mean change from baseline	Blood samples are taken from all participants at baseline and after 12 weeks	Baseline and 12-weeks
Secondary	Fasting insulin mean change from baseline	Blood samples are taken from all participants at baseline and after 12 weeks	Baseline and 12-weeks
Secondary	C-reactive protein mean change from baseline	Blood samples are taken from all participants at baseline and after 12 weeks	Baseline and 12-weeks
Secondary	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
Secondary	Neopterin mean change from baseline	Blood samples are taken from all participants at baseline and after 12 weeks	Baseline and 12-weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Triglycerides mean change from baseline	Blood samples are taken from all participants at baseline and after 12 weeks	Baseline and 12-weeks
Secondary	Total cholesterol mean change from baseline	Blood samples are taken from all participants at baseline and after 12 weeks	Baseline and 12-weeks
Secondary	Fasting glucose mean change from baseline	Blood samples are taken from all participants at baseline and after 12 weeks	Baseline and 12-weeks