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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise Intervention
Lifestyle Physical Activity
Sponsored by
Sheffield Hallam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring polycystic ovary syndrome, exercise, physical activity, cardiovascular disease, low-density lipoprotein, metabolism

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre for Sports and Exercise Science, Sheffield Hallam University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Exercise Intervention

Lifestyle Physical Activity

Control

Arm Description

Structured exercise intervention will be undertaken for 12 weeks

Increased lifestyle physical activity undertaken for 12 weeks

Resting control

Outcomes

Primary Outcome Measures

Recruitment rate
Recruitment rate will be calculated by dividing the number of women eligible and consenting by the recruitment period.
Attrition Rate
Attrition rates will be established as discontinuation of the intervention and loss to follow-up measurement for both conditions.
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
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.

Secondary Outcome Measures

Oxidised low-density lipoprotein mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Free testosterone mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Fasting insulin mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
C-reactive protein mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Thiobarbituric Acid and Reactive Substances (TBARS) mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Neopterin mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Sex hormone binding globulin mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
High density lipoprotein cholesterol mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Low density lipoprotein cholesterol mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Triglycerides mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Total cholesterol mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Fasting glucose mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks

Full Information

First Posted
September 18, 2018
Last Updated
October 27, 2020
Sponsor
Sheffield Hallam University
Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03678714
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Hallam University
Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
polycystic ovary syndrome, exercise, physical activity, cardiovascular disease, low-density lipoprotein, metabolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
Structured exercise intervention will be undertaken for 12 weeks
Arm Title
Lifestyle Physical Activity
Arm Type
Experimental
Arm Description
Increased lifestyle physical activity undertaken for 12 weeks
Arm Title
Control
Arm Type
No Intervention
Arm Description
Resting control
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Physical Activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Recruitment rate will be calculated by dividing the number of women eligible and consenting by the recruitment period.
Time Frame
One year
Title
Attrition Rate
Description
Attrition rates will be established as discontinuation of the intervention and loss to follow-up measurement for both conditions.
Time Frame
One year
Title
Compliance to intervention
Description
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
Time Frame
One year
Title
Suitability of allocation and measurement procedures
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Oxidised low-density lipoprotein mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks
Title
Free testosterone mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks
Title
Fasting insulin mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks
Title
C-reactive protein mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks
Title
Thiobarbituric Acid and Reactive Substances (TBARS) mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks
Title
Neopterin mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks
Title
Sex hormone binding globulin mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks
Title
High density lipoprotein cholesterol mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks
Title
Low density lipoprotein cholesterol mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks
Title
Triglycerides mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks
Title
Total cholesterol mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks
Title
Fasting glucose mean change from baseline
Description
Blood samples are taken from all participants at baseline and after 12 weeks
Time Frame
Baseline and 12-weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amie Woodward, MSc
Organizational Affiliation
Sheffield Hallam University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Markos Klonizakis, PhD
Organizational Affiliation
Sheffield Hallam University
Official's Role
Study Director
Facility Information:
Facility Name
Centre for Sports and Exercise Science, Sheffield Hallam University
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2BP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31959233
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.
Results Reference
derived

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

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