Polycystic Ovary SyndromeIMPROV-ITNCT02419482
Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training
A study testing 4x4 minutes high intensity interval training and 10x1 minute high intensity interval training in people with Polycystic Ovary Syndrome, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
Trial summary
The aim is to investigate whether 16 weeks of high intensity interval training, followed by 36 weeks of home-based exercise, will improve menstrual frequency in women with Polycystic Ovary Syndrome (PCOS) compared with a non-exercising control group. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- 4x4 minutes high intensity interval training and 10x1 minute high intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2015to 1 Apr 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
Who cannot join
- Regular high intensity endurance (two or more times per week of vigorous exercise).
- Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion).
- On-going pregnancy.
- Breast feeding within 24 weeks
- Cardiovascular disease or endocrine disorders
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
Melbourne
Norway1 site
Department of circulation and medical imaging , NTNU
Trondheim, 7491
About this study
Official title: Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial.
The aim is to investigate whether 16 weeks of high intensity interval training, followed by 36 weeks of home-based exercise, will improve menstrual frequency in women with Polycystic Ovary Syndrome (PCOS) compared with a non-exercising control group.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- 4x4 minutes high intensity interval training, 10x1 minute high intensity interval training
- Keywords
- Exercise therapy, Reproductive Physiological Processes, Fertility
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4x4 minutes high intensity interval trainingBehavioural
Also called High-intensity exercise, Aerobic exercise
Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, 4x4 minute intervals at 90-95% of maximum heart rate separated by 3-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.
10x1 minute high intensity interval trainingBehavioural
Also called High-intensity exercise, Aerobic exercise
Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, ten 1-minute intervals at maximal intensity (that can be performed for one minute), separated by 1-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.
| Study group | Role | What they receive |
|---|---|---|
| 4x4 minutes interval training | Experimental | 4x4 minutes high intensity interval training with 4 minute intervals Receives: Behavioral: 4x4 minutes high intensity interval training |
| 10x1 minute interval training | Experimental | 10x1 minute high intensity interval training with 1 minute intervals Receives: Behavioral: 10x1 minute high intensity interval training |
| control | No intervention | Physical activity recommended |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual frequency
Electronic menstrual diary
Measured: 1 year
Secondary outcomes (19)
Body composition
Bioimpedance scale and/or DXA, waist circumference, waist/hip-ratio
Measured: 16 weeks, and 36 weeks
Aerobic capacity
Maximal oxygen uptake measured with Oxygon Pro, Jaeger
Measured: 16 weeks, and 36 weeks
Endothelial function
Flow mediated dilatation of the brachial artery
Measured: 16 weeks, and 36 weeks
Insulin sensitivity
2h oral glucose tolerance test (OGGT)
Measured: 16 weeks, and 36 weeks
Intima-media thickness
Ultrasound of the caroid intima-media thickness
Measured: 16 weeks, and 36 weeks
Oxidative capacity
carbohydrate- and fat oxidation measured with Oxygon Pro, Jaeger
Measured: 16 weeks, and 36 weeks
Low-grade systematic inflammation
Blood samples and adipose tissue
Measured: 16 weeks, and 36 weeks
Adipose tissue morphology and function
Adipose tissue biopsy
Measured: 16 weeks, (and 36 weeks if funded)
Hormone profile, blood lipids and blood values
Blood samples
Measured: 16 weeks, and 36 weeks
Blood pressure
Systolic and diastolic measured with automatic blood pressure device
Measured: 16 weeks, and 36 weeks
Quality of life
PCOS-specific Quality of Life Questionnaire
Measured: 16 weeks
Quality of life
PCOS-specific Quality of Life Questionnaire
Measured: 36 weeks
Physical activity
Physical activity monitor armband (amount and intensity)
Measured: 16 weeks, and 36 weeks
Adipose tissue mRNA expression
mRNA analysis of adipose tissue
Measured: 16 weeks, (and 36 weeks if funded)
ovarian morphology
vaginal ultrasound
Measured: 16 weeks, and 36 weeks
Pregnancy rate
In total, between groups, and among those trying to become pregnant when entering the study
Measured: 16 weeks , and 36 weeks
Enjoyment
Physical Activity Enjoyment Scale (PACES) questionnaire
Measured: weekly up to 16 weeks
Diet
Diet diary
Measured: 16 weeks
Diet
Diet diary
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Liverpool John Moores University, Australian Catholic University
- Responsible party
- Sponsor
- Investigators
- Trine Moholdt, phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419482
- Sponsor's protocol ID
- 2015/468
- Acronym
- IMPROV-IT
- Status last verified
- Aug 2020
- First submitted
- 14 Apr 2015
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lionett S, Kiel IA, Camera DM, Vanky E, Parr EB, Lydersen S, Hawley JA, Moholdt T. Circulating and Adipose Tissue miRNAs in Women With Polycystic Ovary Syndrome and Responses to High-Intensity Interval Training. Front Physiol. 2020 Jul 30;11:904. doi: 10.3389/fphys.2020.00904. eCollection 2020.
PubMed 32848854Kiel IA, Lionett S, Parr EB, Jones H, Roset MAH, Salvesen O, Hawley JA, Vanky E, Moholdt T. High-Intensity Interval Training in Polycystic Ovary Syndrome: A Two-Center, Three-Armed Randomized Controlled Trial. Med Sci Sports Exerc. 2022 May 1;54(5):717-727. doi: 10.1249/MSS.0000000000002849. Epub 2022 Jan 12.
PubMed 35019901Lionett S, Kiel IA, Rosbjorgen R, Lydersen S, Larsen S, Moholdt T. Absent Exercise-Induced Improvements in Fat Oxidation in Women With Polycystic Ovary Syndrome After High-Intensity Interval Training. Front Physiol. 2021 Mar 24;12:649794. doi: 10.3389/fphys.2021.649794. eCollection 2021.
PubMed 33841184Kiel IA, Lionett S, Parr EB, Jones H, Roset MAH, Salvesen O, Vanky E, Moholdt T. Improving reproductive function in women with polycystic ovary syndrome with high-intensity interval training (IMPROV-IT): study protocol for a two-centre, three-armed randomised controlled trial. BMJ Open. 2020 Feb 20;10(2):e034733. doi: 10.1136/bmjopen-2019-034733.
PubMed 32086359
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02419482
- Acronym / sponsor ID
- IMPROV-IT / 2015/468
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Exercise therapy, Reproductive Physiological Processes, Fertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Liverpool John Moores University, Australian Catholic University
- Study start
- Jun 2015 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 17 Apr 2015 (estimated)
- 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.
The aim is to investigate whether 16 weeks of high intensity interval training, followed by 36 weeks of home-based exercise, will improve menstrual frequency in women with Polycystic Ovary Syndrome (PCOS) compared with a non-exercising control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4x4 minutes interval training | Experimental | Behavioral: 4x4 minutes high intensity interval training4x4 minutes high intensity interval training with 4 minute intervals |
| 10x1 minute interval training | Experimental | Behavioral: 10x1 minute high intensity interval training10x1 minute high intensity interval training with 1 minute intervals |
| control | No intervention | –Physical activity recommended |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
Key exclusion criteria (5 listed)
- Regular high intensity endurance (two or more times per week of vigorous exercise).
- Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion).
- On-going pregnancy.
- Breast feeding within 24 weeks
- Cardiovascular disease or endocrine disorders
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 |
|---|---|---|
| 4x4 minutes high intensity interval trainingAlso: High-intensity exercise, Aerobic exerciseTreadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, 4x4 minute intervals at 90-95% of maximum heart rate separated by 3-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down. | Behavioural | 4x4 minutes interval training |
| 10x1 minute high intensity interval trainingAlso: High-intensity exercise, Aerobic exerciseTreadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, ten 1-minute intervals at maximal intensity (that can be performed for one minute), separated by 1-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down. | Behavioural | 10x1 minute interval training |
Primary outcome
Menstrual frequency
Time frame: 1 year
Electronic menstrual diary
19 secondary outcomes
Body composition
Time frame: 16 weeks, and 36 weeks
Aerobic capacity
Time frame: 16 weeks, and 36 weeks
Endothelial function
Time frame: 16 weeks, and 36 weeks
Insulin sensitivity
Time frame: 16 weeks, and 36 weeks
Intima-media thickness
Time frame: 16 weeks, and 36 weeks
Oxidative capacity
Time frame: 16 weeks, and 36 weeks
Low-grade systematic inflammation
Time frame: 16 weeks, and 36 weeks
Adipose tissue morphology and function
Time frame: 16 weeks, (and 36 weeks if funded)
Hormone profile, blood lipids and blood values
Time frame: 16 weeks, and 36 weeks
Blood pressure
Time frame: 16 weeks, and 36 weeks
Quality of life
Time frame: 16 weeks
Quality of life
Time frame: 36 weeks
Physical activity
Time frame: 16 weeks, and 36 weeks
Adipose tissue mRNA expression
Time frame: 16 weeks, (and 36 weeks if funded)
ovarian morphology
Time frame: 16 weeks, and 36 weeks
Pregnancy rate
Time frame: 16 weeks , and 36 weeks
Enjoyment
Time frame: weekly up to 16 weeks
Diet
Time frame: 16 weeks
Diet
Time frame: 36 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 2 Sep 2020.
- Results publication: PubMed 32848854Lionett S, Kiel IA, Camera DM, Vanky E, Parr EB, Lydersen S, Hawley JA, Moholdt T. Circulating and Adipose Tissue miRNAs in Women With Polycystic Ovary Syndrome and Responses to High-Intensity Interval Training. Front Physiol. 2020 Jul 30;11:904. doi: 10.3389/fphys.2020.00904. eCollection 2020.
- Derived from this study: PubMed 35019901Kiel IA, Lionett S, Parr EB, Jones H, Roset MAH, Salvesen O, Hawley JA, Vanky E, Moholdt T. High-Intensity Interval Training in Polycystic Ovary Syndrome: A Two-Center, Three-Armed Randomized Controlled Trial. Med Sci Sports Exerc. 2022 May 1;54(5):717-727. doi: 10.1249/MSS.0000000000002849. Epub 2022 Jan 12.
- Derived from this study: PubMed 33841184Lionett S, Kiel IA, Rosbjorgen R, Lydersen S, Larsen S, Moholdt T. Absent Exercise-Induced Improvements in Fat Oxidation in Women With Polycystic Ovary Syndrome After High-Intensity Interval Training. Front Physiol. 2021 Mar 24;12:649794. doi: 10.3389/fphys.2021.649794. eCollection 2021.
- Derived from this study: PubMed 32086359Kiel IA, Lionett S, Parr EB, Jones H, Roset MAH, Salvesen O, Vanky E, Moholdt T. Improving reproductive function in women with polycystic ovary syndrome with high-intensity interval training (IMPROV-IT): study protocol for a two-centre, three-armed randomised controlled trial. BMJ Open. 2020 Feb 20;10(2):e034733. doi: 10.1136/bmjopen-2019-034733.
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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.
Trine Moholdt, phd principal investigator
Norwegian University of Science and Technology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4x4 minutes high intensity interval training and 10x1 minute high intensity interval training in people with Polycystic Ovary Syndrome, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
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 1 inclusion and 5 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 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Norway. 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?
Menstrual frequency (time frame: 1 year). 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 NCT02419482, which also lists 4 linked publications.
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 2 Sep 2020.