NCT02419482

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

4.8 years

First QC Date

April 14, 2015

Last Update Submit

August 31, 2020

Conditions

Polycystic Ovary Syndrome

Keywords

Exercise therapyReproductive Physiological ProcessesFertility

Outcome Measures

Primary Outcomes (1)

  • Menstrual frequency

    Electronic menstrual diary

    1 year

Secondary Outcomes (19)

  • Body composition

    16 weeks, and 36 weeks

  • Aerobic capacity

    16 weeks, and 36 weeks

  • Endothelial function

    16 weeks, and 36 weeks

  • Insulin sensitivity

    16 weeks, and 36 weeks

  • Intima-media thickness

    16 weeks, and 36 weeks

  • +14 more secondary outcomes

Study Arms (3)

4x4 minutes interval training

EXPERIMENTAL

4x4 minutes high intensity interval training with 4 minute intervals

Behavioral: 4x4 minutes high intensity interval training

10x1 minute interval training

EXPERIMENTAL

10x1 minute high intensity interval training with 1 minute intervals

Behavioral: 10x1 minute high intensity interval training

control

NO INTERVENTION

Physical activity recommended

Interventions

4x4 minutes high intensity interval trainingBEHAVIORAL

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.

Also known as: High-intensity exercise, Aerobic exercise
4x4 minutes interval training
10x1 minute high intensity interval trainingBEHAVIORAL

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.

Also known as: High-intensity exercise, Aerobic exercise
10x1 minute interval training

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Regular high intensity endurance (two or more times per week of vigorous exercise).
  • On-going pregnancy.
  • Breast feeding within 24 weeks
  • Cardiovascular disease or endocrine disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Melbourne, Australia

Location

Department of circulation and medical imaging , NTNU

Trondheim, 7491, Norway

Location

Related Publications (4)

  • 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.

    PMID: 32848854RESULT

  • 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.

    PMID: 35019901DERIVED

  • 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.

    PMID: 33841184DERIVED

  • 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.

    PMID: 32086359DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

High-Intensity Interval TrainingExercise

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Trine Moholdt, phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 17, 2015

Study Start

June 1, 2015

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

September 2, 2020

Record last verified: 2020-08

Locations

AU(1)NO(1)