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| Name | Class |
|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention | Experimental | Structured exercise intervention will be undertaken for 12 weeks |
|
| Lifestyle Physical Activity | Experimental | Increased lifestyle physical activity undertaken for 12 weeks |
|
| Control | No Intervention | Resting control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidised low-density lipoprotein mean change from baseline | Blood samples are taken from all participants at baseline and after 12 weeks | Baseline and 12-weeks |
| Free testosterone mean change from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amie Woodward, MSc | Sheffield Hallam University | Principal Investigator |
| Markos Klonizakis, PhD | Sheffield Hallam University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Sports and Exercise Science, Sheffield Hallam University | Sheffield | England | S10 2BP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31959233 | Derived | 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. |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D009043 | Motor Activity |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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Participants will be randomised into either an exercise group, a lifestyle physical activity group, or a control group, for a duration of 12 weeks.
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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.
|
| Lifestyle Physical Activity | Behavioral | 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. |
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Blood samples are taken from all participants at baseline and after 12 weeks
| Baseline and 12-weeks |
| Fasting insulin mean change from baseline | Blood samples are taken from all participants at baseline and after 12 weeks | Baseline and 12-weeks |
| C-reactive protein mean change from baseline | Blood samples are taken from all participants at baseline and after 12 weeks | 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 | Baseline and 12-weeks |
| Neopterin mean change from baseline | Blood samples are taken from all participants at baseline and after 12 weeks | 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 | 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 | 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 | Baseline and 12-weeks |
| Triglycerides mean change from baseline | Blood samples are taken from all participants at baseline and after 12 weeks | Baseline and 12-weeks |
| Total cholesterol mean change from baseline | Blood samples are taken from all participants at baseline and after 12 weeks | Baseline and 12-weeks |
| Fasting glucose mean change from baseline | Blood samples are taken from all participants at baseline and after 12 weeks | Baseline and 12-weeks |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |