Effect of Exercise on Cardiometabolic Profile in Women With Polycystic Ovary Syndrome
NCT ID: NCT03678714
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2018-10-01
2020-05-30
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exercise Intervention
Structured exercise intervention will be undertaken for 12 weeks
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
Increased lifestyle physical activity undertaken for 12 weeks
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.
Control
Resting control
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
50 Years
FEMALE
No
Sponsors
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Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Sheffield Hallam University
OTHER
Responsible Party
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Principal Investigators
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Amie Woodward, MSc
Role: PRINCIPAL_INVESTIGATOR
Sheffield Hallam University
Markos Klonizakis, PhD
Role: STUDY_DIRECTOR
Sheffield Hallam University
Locations
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Centre for Sports and Exercise Science, Sheffield Hallam University
Sheffield, England, United Kingdom
Countries
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References
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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.
Other Identifiers
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ER6262197
Identifier Type: -
Identifier Source: org_study_id