Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training

NCT ID: NCT02419482

Last Updated: 2020-09-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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4x4 minutes interval training

4x4 minutes high intensity interval training with 4 minute intervals

Group Type EXPERIMENTAL

4x4 minutes high intensity interval training

Intervention Type BEHAVIORAL

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 interval training

10x1 minute high intensity interval training with 1 minute intervals

Group Type EXPERIMENTAL

10x1 minute high intensity interval training

Intervention Type BEHAVIORAL

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.

control

Physical activity recommended

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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4x4 minutes high intensity interval training

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.

Intervention Type BEHAVIORAL

10x1 minute high intensity interval training

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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High-intensity exercise Aerobic exercise High-intensity exercise Aerobic exercise

Eligibility Criteria

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Inclusion Criteria

* Polycystic ovary syndrome (PCOS) according to the Rotterdam criteria

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Liverpool John Moores University

OTHER

Sponsor Role collaborator

Australian Catholic University

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Trine Moholdt, phd

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC

Melbourne, , Australia

Site Status

Department of circulation and medical imaging , NTNU

Trondheim, , Norway

Site Status

Countries

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Australia Norway

References

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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.

Reference Type RESULT
PMID: 32848854 (View on PubMed)

Kiel 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.

Reference Type DERIVED
PMID: 35019901 (View on PubMed)

Lionett 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.

Reference Type DERIVED
PMID: 33841184 (View on PubMed)

Kiel 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.

Reference Type DERIVED
PMID: 32086359 (View on PubMed)

Other Identifiers

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2015/468

Identifier Type: -

Identifier Source: org_study_id

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