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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02419482




Registration number
NCT02419482
Ethics application status
Date submitted
14/04/2015
Date registered
17/04/2015
Date last updated
2/09/2020

Titles & IDs
Public title
Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training
Scientific title
Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial.
Secondary ID [1] 0 0
2015/468
Universal Trial Number (UTN)
Trial acronym
IMPROV-IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - 4x4 minutes high intensity interval training
BEHAVIORAL - 10x1 minute high intensity interval training

Experimental: 4x4 minutes interval training - 4x4 minutes high intensity interval training with 4 minute intervals

Experimental: 10x1 minute interval training - 10x1 minute high intensity interval training with 1 minute intervals

No intervention: control - Physical activity recommended


BEHAVIORAL: 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.

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 code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Menstrual frequency
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Body composition
Timepoint [1] 0 0
16 weeks, and 36 weeks
Secondary outcome [2] 0 0
Aerobic capacity
Timepoint [2] 0 0
16 weeks, and 36 weeks
Secondary outcome [3] 0 0
Endothelial function
Timepoint [3] 0 0
16 weeks, and 36 weeks
Secondary outcome [4] 0 0
Insulin sensitivity
Timepoint [4] 0 0
16 weeks, and 36 weeks
Secondary outcome [5] 0 0
Intima-media thickness
Timepoint [5] 0 0
16 weeks, and 36 weeks
Secondary outcome [6] 0 0
Oxidative capacity
Timepoint [6] 0 0
16 weeks, and 36 weeks
Secondary outcome [7] 0 0
Low-grade systematic inflammation
Timepoint [7] 0 0
16 weeks, and 36 weeks
Secondary outcome [8] 0 0
Adipose tissue morphology and function
Timepoint [8] 0 0
16 weeks, (and 36 weeks if funded)
Secondary outcome [9] 0 0
Hormone profile, blood lipids and blood values
Timepoint [9] 0 0
16 weeks, and 36 weeks
Secondary outcome [10] 0 0
Blood pressure
Timepoint [10] 0 0
16 weeks, and 36 weeks
Secondary outcome [11] 0 0
Quality of life
Timepoint [11] 0 0
16 weeks
Secondary outcome [12] 0 0
Quality of life
Timepoint [12] 0 0
36 weeks
Secondary outcome [13] 0 0
Physical activity
Timepoint [13] 0 0
16 weeks, and 36 weeks
Secondary outcome [14] 0 0
Adipose tissue mRNA expression
Timepoint [14] 0 0
16 weeks, (and 36 weeks if funded)
Secondary outcome [15] 0 0
ovarian morphology
Timepoint [15] 0 0
16 weeks, and 36 weeks
Secondary outcome [16] 0 0
Pregnancy rate
Timepoint [16] 0 0
16 weeks , and 36 weeks
Secondary outcome [17] 0 0
Enjoyment
Timepoint [17] 0 0
weekly up to 16 weeks
Secondary outcome [18] 0 0
Diet
Timepoint [18] 0 0
16 weeks
Secondary outcome [19] 0 0
Diet
Timepoint [19] 0 0
36 weeks

Eligibility
Key inclusion criteria
* Polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2020
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Centre of Exercise and Nutrition, Mary MacKillop Institute for Health Research, AUC - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Norway
State/province [1] 0 0
Trondheim

Funding & Sponsors
Primary sponsor type
Other
Name
Norwegian University of Science and Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St. Olavs Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Liverpool John Moores University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Australian Catholic University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02419482
Trial related presentations / 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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Trine Moholdt, phd
Address 0 0
Norwegian University of Science and Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02419482