Polycystic Ovary SyndromeNCT03678714
Effect of Exercise on Cardiometabolic Profile in Women With Polycystic Ovary Syndrome
A study testing Exercise Intervention and Lifestyle Physical Activity in people with Polycystic Ovary Syndrome, run by Sheffield Hallam University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Exercise Intervention and Lifestyle Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Sports and Exercise Science, Sheffield Hallam University
Sheffield, England, S10 2BP
About this study
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
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Exercise Intervention, Lifestyle Physical Activity
- Keywords
- polycystic ovary syndrome, exercise, physical activity, cardiovascular disease, low-density lipoprotein, metabolism
- Medical subject headings
- Polycystic Ovary Syndrome, Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
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 ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Structured exercise intervention will be undertaken for 12 weeks Receives: Behavioral: Exercise Intervention |
| Lifestyle Physical Activity | Experimental | Increased lifestyle physical activity undertaken for 12 weeks Receives: Behavioral: Lifestyle Physical Activity |
| Control | No intervention | Resting control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment rate will be calculated by dividing the number of women eligible and consenting by the recruitment period.
Measured: One year
Attrition Rate
Attrition rates will be established as discontinuation of the intervention and loss to follow-up measurement for both conditions.
Measured: 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
Measured: 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.
Measured: One year
Secondary outcomes (12)
Oxidised low-density lipoprotein mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Measured: Baseline and 12-weeks
Free testosterone mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Measured: Baseline and 12-weeks
Fasting insulin mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Measured: Baseline and 12-weeks
C-reactive protein mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Measured: Baseline and 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
Measured: Baseline and 12-weeks
Neopterin mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Measured: Baseline and 12-weeks
Sex hormone binding globulin mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Measured: Baseline and 12-weeks
High density lipoprotein cholesterol mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Measured: Baseline and 12-weeks
Low density lipoprotein cholesterol mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Measured: Baseline and 12-weeks
Triglycerides mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Measured: Baseline and 12-weeks
Total cholesterol mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Measured: Baseline and 12-weeks
Fasting glucose mean change from baseline
Blood samples are taken from all participants at baseline and after 12 weeks
Measured: Baseline and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Oct 2018
- Primary completion30 Apr 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Amie Woodward, MSc, Principal investigator, Sheffield Hallam UniversityMarkos Klonizakis, PhD, Study director, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678714
- Sponsor's protocol ID
- ER6262197
- Status last verified
- Oct 2020
- First submitted
- 18 Sep 2018
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31959233
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03678714
- Acronym / sponsor ID
- ER6262197
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome, exercise, physical activity, cardiovascular disease, low-density lipoprotein, metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Exercise InterventionStructured exercise intervention will be undertaken for 12 weeks |
| Lifestyle Physical Activity | Experimental | Behavioral: Lifestyle Physical ActivityIncreased lifestyle physical activity undertaken for 12 weeks |
| Control | No intervention | –Resting control |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Intervention2 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. | Behavioural | Exercise Intervention |
| Lifestyle Physical ActivityAdvice 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. | Behavioural | Lifestyle Physical Activity |
Primary outcome
Recruitment rate
Time frame: One year
Recruitment rate will be calculated by dividing the number of women eligible and consenting by the recruitment period.
Attrition Rate
Time frame: One year
Attrition rates will be established as discontinuation of the intervention and loss to follow-up measurement for both conditions.
Compliance to intervention
Time frame: One year
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
Time frame: One year
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.
12 secondary outcomes
Oxidised low-density lipoprotein mean change from baseline
Time frame: Baseline and 12-weeks
Free testosterone mean change from baseline
Time frame: Baseline and 12-weeks
Fasting insulin mean change from baseline
Time frame: Baseline and 12-weeks
C-reactive protein mean change from baseline
Time frame: Baseline and 12-weeks
Thiobarbituric Acid and Reactive Substances (TBARS) mean change from baseline
Time frame: Baseline and 12-weeks
Neopterin mean change from baseline
Time frame: Baseline and 12-weeks
Sex hormone binding globulin mean change from baseline
Time frame: Baseline and 12-weeks
High density lipoprotein cholesterol mean change from baseline
Time frame: Baseline and 12-weeks
Low density lipoprotein cholesterol mean change from baseline
Time frame: Baseline and 12-weeks
Triglycerides mean change from baseline
Time frame: Baseline and 12-weeks
Total cholesterol mean change from baseline
Time frame: Baseline and 12-weeks
Fasting glucose mean change from baseline
Time frame: Baseline and 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Derived from this study: PubMed 31959233Woodward 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amie Woodward, MSc principal investigator
Sheffield Hallam University
Markos Klonizakis, PhD study director
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention and Lifestyle Physical Activity in people with Polycystic Ovary Syndrome, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03678714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.