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
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2018
CompletedFirst Posted
Study publicly available on registry
September 20, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2020
CompletedOctober 29, 2020
October 1, 2020
1.6 years
September 18, 2018
October 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Recruitment rate
Recruitment rate will be calculated by dividing the number of women eligible and consenting by the recruitment period.
One year
Attrition Rate
Attrition rates will be established as discontinuation of the intervention and loss to follow-up measurement for both conditions.
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
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.
One year
Secondary Outcomes (12)
Oxidised low-density lipoprotein mean change from baseline
Baseline and 12-weeks
Free testosterone 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
Thiobarbituric Acid and Reactive Substances (TBARS) mean change from baseline
Baseline and 12-weeks
- +7 more secondary outcomes
Study Arms (3)
Exercise Intervention
EXPERIMENTALStructured exercise intervention will be undertaken for 12 weeks
Lifestyle Physical Activity
EXPERIMENTALIncreased lifestyle physical activity undertaken for 12 weeks
Control
NO INTERVENTIONResting control
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Sports and Exercise Science, Sheffield Hallam University
Sheffield, England, S10 2BP, United Kingdom
Related Publications (1)
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.
PMID: 31959233DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amie Woodward, MSc
Sheffield Hallam University
- STUDY DIRECTOR
Markos Klonizakis, PhD
Sheffield Hallam University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2018
First Posted
September 20, 2018
Study Start
October 1, 2018
Primary Completion
April 30, 2020
Study Completion
May 30, 2020
Last Updated
October 29, 2020
Record last verified: 2020-10