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Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training (IMPROV-IT)

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
4x4 minutes high intensity interval training
10x1 minute high intensity interval training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Exercise therapy, Reproductive Physiological Processes, Fertility

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
  • Department of circulation and medical imaging , NTNU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

4x4 minutes interval training

10x1 minute interval training

control

Arm Description

4x4 minutes high intensity interval training with 4 minute intervals

10x1 minute high intensity interval training with 1 minute intervals

Physical activity recommended

Outcomes

Primary Outcome Measures

Menstrual frequency
Electronic menstrual diary

Secondary Outcome Measures

Body composition
Bioimpedance scale and/or DXA, waist circumference, waist/hip-ratio
Aerobic capacity
Maximal oxygen uptake measured with Oxygon Pro, Jaeger
Endothelial function
Flow mediated dilatation of the brachial artery
Insulin sensitivity
2h oral glucose tolerance test (OGGT)
Intima-media thickness
Ultrasound of the caroid intima-media thickness
Oxidative capacity
carbohydrate- and fat oxidation measured with Oxygon Pro, Jaeger
Low-grade systematic inflammation
Blood samples and adipose tissue
Adipose tissue morphology and function
Adipose tissue biopsy
Hormone profile, blood lipids and blood values
Blood samples
Blood pressure
Systolic and diastolic measured with automatic blood pressure device
Quality of life
PCOS-specific Quality of Life Questionnaire
Quality of life
PCOS-specific Quality of Life Questionnaire
Physical activity
Physical activity monitor armband (amount and intensity)
Adipose tissue mRNA expression
mRNA analysis of adipose tissue
ovarian morphology
vaginal ultrasound
Pregnancy rate
In total, between groups, and among those trying to become pregnant when entering the study
Enjoyment
Physical Activity Enjoyment Scale (PACES) questionnaire
Diet
Diet diary
Diet
Diet diary

Full Information

First Posted
April 14, 2015
Last Updated
August 31, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Liverpool John Moores University, Australian Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT02419482
Brief Title
Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training
Acronym
IMPROV-IT
Official Title
Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Liverpool John Moores University, Australian Catholic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Exercise therapy, Reproductive Physiological Processes, Fertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4x4 minutes interval training
Arm Type
Experimental
Arm Description
4x4 minutes high intensity interval training with 4 minute intervals
Arm Title
10x1 minute interval training
Arm Type
Experimental
Arm Description
10x1 minute high intensity interval training with 1 minute intervals
Arm Title
control
Arm Type
No Intervention
Arm Description
Physical activity recommended
Intervention Type
Behavioral
Intervention Name(s)
4x4 minutes high intensity interval training
Other Intervention Name(s)
High-intensity exercise, Aerobic exercise
Intervention Description
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
Intervention Name(s)
10x1 minute high intensity interval training
Other Intervention Name(s)
High-intensity exercise, Aerobic exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Menstrual frequency
Description
Electronic menstrual diary
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Body composition
Description
Bioimpedance scale and/or DXA, waist circumference, waist/hip-ratio
Time Frame
16 weeks, and 36 weeks
Title
Aerobic capacity
Description
Maximal oxygen uptake measured with Oxygon Pro, Jaeger
Time Frame
16 weeks, and 36 weeks
Title
Endothelial function
Description
Flow mediated dilatation of the brachial artery
Time Frame
16 weeks, and 36 weeks
Title
Insulin sensitivity
Description
2h oral glucose tolerance test (OGGT)
Time Frame
16 weeks, and 36 weeks
Title
Intima-media thickness
Description
Ultrasound of the caroid intima-media thickness
Time Frame
16 weeks, and 36 weeks
Title
Oxidative capacity
Description
carbohydrate- and fat oxidation measured with Oxygon Pro, Jaeger
Time Frame
16 weeks, and 36 weeks
Title
Low-grade systematic inflammation
Description
Blood samples and adipose tissue
Time Frame
16 weeks, and 36 weeks
Title
Adipose tissue morphology and function
Description
Adipose tissue biopsy
Time Frame
16 weeks, (and 36 weeks if funded)
Title
Hormone profile, blood lipids and blood values
Description
Blood samples
Time Frame
16 weeks, and 36 weeks
Title
Blood pressure
Description
Systolic and diastolic measured with automatic blood pressure device
Time Frame
16 weeks, and 36 weeks
Title
Quality of life
Description
PCOS-specific Quality of Life Questionnaire
Time Frame
16 weeks
Title
Quality of life
Description
PCOS-specific Quality of Life Questionnaire
Time Frame
36 weeks
Title
Physical activity
Description
Physical activity monitor armband (amount and intensity)
Time Frame
16 weeks, and 36 weeks
Title
Adipose tissue mRNA expression
Description
mRNA analysis of adipose tissue
Time Frame
16 weeks, (and 36 weeks if funded)
Title
ovarian morphology
Description
vaginal ultrasound
Time Frame
16 weeks, and 36 weeks
Title
Pregnancy rate
Description
In total, between groups, and among those trying to become pregnant when entering the study
Time Frame
16 weeks , and 36 weeks
Title
Enjoyment
Description
Physical Activity Enjoyment Scale (PACES) questionnaire
Time Frame
weekly up to 16 weeks
Title
Diet
Description
Diet diary
Time Frame
16 weeks
Title
Diet
Description
Diet diary
Time Frame
36 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trine Moholdt, phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC
City
Melbourne
Country
Australia
Facility Name
Department of circulation and medical imaging , NTNU
City
Trondheim
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32848854
Citation
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.
Results Reference
result
PubMed Identifier
35019901
Citation
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.
Results Reference
derived
PubMed Identifier
33841184
Citation
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.
Results Reference
derived
PubMed Identifier
32086359
Citation
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.
Results Reference
derived

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

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