Clinical trial NCT03678714: Effect of Exercise on Cardiometabolic Profile in Women With Polycystic Ovary Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome
exercise
physical activity
cardiovascular disease
low-density lipoprotein
metabolism
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2018-09-20
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: One year
measure: Attrition Rate
timeFrame: One year
measure: Compliance to intervention
timeFrame: One year
measure: Suitability of allocation and measurement procedures
timeFrame: One year
Secondary outcomes:
measure: Oxidised low-density lipoprotein mean change from baseline
timeFrame: Baseline and 12-weeks
measure: Free testosterone mean change from baseline
timeFrame: Baseline and 12-weeks
measure: Fasting insulin mean change from baseline
timeFrame: Baseline and 12-weeks
measure: C-reactive protein mean change from baseline
timeFrame: Baseline and 12-weeks
measure: Thiobarbituric Acid and Reactive Substances (TBARS) mean change from baseline
timeFrame: Baseline and 12-weeks
measure: Neopterin mean change from baseline
timeFrame: Baseline and 12-weeks
measure: Sex hormone binding globulin mean change from baseline
timeFrame: Baseline and 12-weeks
measure: High density lipoprotein cholesterol mean change from baseline
timeFrame: Baseline and 12-weeks
measure: Low density lipoprotein cholesterol mean change from baseline
timeFrame: Baseline and 12-weeks
measure: Triglycerides mean change from baseline
timeFrame: Baseline and 12-weeks
measure: Total cholesterol mean change from baseline
timeFrame: Baseline and 12-weeks
measure: Fasting glucose mean change from baseline
timeFrame: Baseline and 12-weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Centre for Sports and Exercise Science, Sheffield Hallam University
state: England
Study officials:
affiliation: Sheffield Hallam University
name: Amie Woodward, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheffield Hallam University
name: Markos Klonizakis, PhD
role: STUDY_DIRECTOR
References:
citation: Woodward A, Broom D, Dalton C, Metwally M, Klonizakis M. Supervised exercise training and increased physical activity to reduce cardiovascular disease risk in women with polycystic ovary syndrome: study protocol for a randomized controlled feasibility trial. Trials. 2020 Jan 20;21(1):101. doi: 10.1186/s13063-019-3962-7.