Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-01-01
2020-04-17
Brief Summary
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Non-pharmacological treatments are appealing to many reproductive age women. There is preliminary evidence that exercise in PCOS may increase menstrual regularity, ovulation, cardiorespiratory fitness, health-related quality of life (HRQOL) and self-esteem, and decrease body fat and insulin resistance. These studies have been limited by short durations and lack of randomization or appropriate control groups.
High-intensity interval training (HIIT), which involves brief intervals of near-maximal exercise alternating with lower-intensity exercise, is becoming increasingly popular in the exercise community. In some non-PCOS trials, HIIT resulted in improved cardiovascular fitness and greater fat loss compared with continuous aerobic exercise. No other trials are currently on-going that are comparing HIIT with continuous aerobic exercise training in women with PCOS (as confirmed by searches of the literature and the clinical trials registry maintained by the US NIH).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control Group
Participants randomized to the control group will continue with their usual level of physical activity. They will track their menstrual cycles and perform daily ovulation tests.
Once all post-intervention assessments are complete, they will have the option to begin an exercise program with three supervised sessions of either high-intensity interval training or continuous aerobic exercise training free of charge. They will be given a Polar heart rate (HR) monitor as a gift for their participation in the study.
No interventions assigned to this group
High-Intensity Interval Training
Participants randomized to this group will complete three high intensity interval training sessions per week, two of which will be supervised. They will exercise for a total of 30 minutes per session. Each session will begin with a five-minute warm-up and end with a five-minute cool-down.
High Intensity Interval Training
The exercise prescription is as follows:
Type: High-Intensity Interval Training on a treadmill, elliptical trainer or cycle ergometer.
Intensity: 30 seconds of high-intensity alternating with 90 seconds of low intensity for a total of 10 cycles
* High intensity for most individuals will occur at approximately 90% of maximum heart rate. Using the rating of perceived exertion scale, participants should be exercising at a 9/10, which is very difficult to maintain the intensity and results in only being able to speak a few words at a time.
* Low intensity is defined as light activity and rated as 2-3/10 on the rating of perceived exertion scale. Participants should be able to carry on a conversation and maintain the pace for hours.
Duration: 30 minutes Frequency: 3 times per week
Continuous Aerobic Exercise Training
Participants randomized to this group will complete three continuous aerobic training sessions per week, two of which will be supervised. They will exercise for a total of 50 minutes per session. Each session will begin with a five-minute warm-up and end with a five-minute cool down.
Continuous Aerobic Exercise Training
The exercise prescription for the continuous aerobic exercise group is as follows:
Type: Aerobic exercise including walking, running, cycling or using the elliptical trainer.
Intensity: Moderate intensity, defined as 50-60% of the participant's maximum heart rate. On the rating of perceived exertion scale, this corresponds with a 4-6/10, which allows participants to hold a conversation while breathing heavily.
Duration: 50 minutes Frequency: 3 times per week
Interventions
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High Intensity Interval Training
The exercise prescription is as follows:
Type: High-Intensity Interval Training on a treadmill, elliptical trainer or cycle ergometer.
Intensity: 30 seconds of high-intensity alternating with 90 seconds of low intensity for a total of 10 cycles
* High intensity for most individuals will occur at approximately 90% of maximum heart rate. Using the rating of perceived exertion scale, participants should be exercising at a 9/10, which is very difficult to maintain the intensity and results in only being able to speak a few words at a time.
* Low intensity is defined as light activity and rated as 2-3/10 on the rating of perceived exertion scale. Participants should be able to carry on a conversation and maintain the pace for hours.
Duration: 30 minutes Frequency: 3 times per week
Continuous Aerobic Exercise Training
The exercise prescription for the continuous aerobic exercise group is as follows:
Type: Aerobic exercise including walking, running, cycling or using the elliptical trainer.
Intensity: Moderate intensity, defined as 50-60% of the participant's maximum heart rate. On the rating of perceived exertion scale, this corresponds with a 4-6/10, which allows participants to hold a conversation while breathing heavily.
Duration: 50 minutes Frequency: 3 times per week
Eligibility Criteria
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Inclusion Criteria
1. Oligo-ovulation or anovulation. Oligo-ovulation is defined as menstrual cycles greater than 35 days or less than 8 menstrual cycles per year. Anovulation is defined as no ovulation in more than 90 days.
2. Clinical and/or biochemical signs of hyperandrogenism. Clinical hyperandrogenism is defined as a modified Ferriman Gallwey score greater than or equal to 8. Biochemical hyperandrogenism is defined as a free androgen index greater than or equal to 5.1.
3. Polycystic ovaries defined as the presence of 12 or more follicles in each ovary measuring 2-9 mm in diameter, and/or increased ovarian volume (\>10 mL).
Exclusion Criteria
* Participants must not be pregnant or breastfeeding within the three months prior to enrolment and must not be using or have used a hormonal contraceptive within three months of enrolment.
* Participants will be excluded if they are taking any medications to treat insulin resistance including metformin, medications likely to increase insulin resistance such as corticosteroids, or any medications that may affect ovulation including clomiphene citrate, letrozole, or gonadotropins. They must not be taking medications to treat hirsutism including spironolactone.
* Participants must not be habitually exercising more than two times per week for more than twenty minutes per session.
* Participants must be able to participate in the exercise intervention, therefore will be excluded if they have a physical injury, illness or disability that prevents them from doing so.
18 Years
40 Years
FEMALE
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Locations
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University of Calgary Clinical Trials Unit
Calgary, Alberta, Canada
Countries
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References
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Lizneva D, Suturina L, Walker W, Brakta S, Gavrilova-Jordan L, Azziz R. Criteria, prevalence, and phenotypes of polycystic ovary syndrome. Fertil Steril. 2016 Jul;106(1):6-15. doi: 10.1016/j.fertnstert.2016.05.003. Epub 2016 May 24.
Sirmans SM, Pate KA. Epidemiology, diagnosis, and management of polycystic ovary syndrome. Clin Epidemiol. 2013 Dec 18;6:1-13. doi: 10.2147/CLEP.S37559.
Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
Legro RS, Arslanian SA, Ehrmann DA, Hoeger KM, Murad MH, Pasquali R, Welt CK; Endocrine Society. Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2013 Dec;98(12):4565-92. doi: 10.1210/jc.2013-2350. Epub 2013 Oct 22.
Thomson RL, Buckley JD, Noakes M, Clifton PM, Norman RJ, Brinkworth GD. The effect of a hypocaloric diet with and without exercise training on body composition, cardiometabolic risk profile, and reproductive function in overweight and obese women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Sep;93(9):3373-80. doi: 10.1210/jc.2008-0751. Epub 2008 Jun 26.
Turan V, Mutlu EK, Solmaz U, Ekin A, Tosun O, Tosun G, Mat E, Gezer C, Malkoc M. Benefits of short-term structured exercise in non-overweight women with polycystic ovary syndrome: a prospective randomized controlled study. J Phys Ther Sci. 2015 Jul;27(7):2293-7. doi: 10.1589/jpts.27.2293. Epub 2015 Jul 22.
Vizza L, Smith CA, Swaraj S, Agho K, Cheema BS. The feasibility of progressive resistance training in women with polycystic ovary syndrome: a pilot randomized controlled trial. BMC Sports Sci Med Rehabil. 2016 May 11;8:14. doi: 10.1186/s13102-016-0039-8. eCollection 2016.
Aubuchon M, Laughbaum N, Poetker A, Williams D, Thomas M. Supervised short-term nutrition and exercise promotes weight loss in overweight and obese patients with polycystic ovary syndrome. Fertil Steril. 2009 Apr;91(4 Suppl):1336-8. doi: 10.1016/j.fertnstert.2008.03.028. Epub 2008 Jun 13.
Nybacka A, Carlstrom K, Stahle A, Nyren S, Hellstrom PM, Hirschberg AL. Randomized comparison of the influence of dietary management and/or physical exercise on ovarian function and metabolic parameters in overweight women with polycystic ovary syndrome. Fertil Steril. 2011 Dec;96(6):1508-13. doi: 10.1016/j.fertnstert.2011.09.006. Epub 2011 Sep 29.
Jedel E, Labrie F, Oden A, Holm G, Nilsson L, Janson PO, Lind AK, Ohlsson C, Stener-Victorin E. Impact of electro-acupuncture and physical exercise on hyperandrogenism and oligo/amenorrhea in women with polycystic ovary syndrome: a randomized controlled trial. Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E37-45. doi: 10.1152/ajpendo.00495.2010. Epub 2010 Oct 13.
Thomson RL, Buckley JD, Brinkworth GD. Exercise for the treatment and management of overweight women with polycystic ovary syndrome: a review of the literature. Obes Rev. 2011 May;12(5):e202-10. doi: 10.1111/j.1467-789X.2010.00758.x.
Batacan RB Jr, Duncan MJ, Dalbo VJ, Tucker PS, Fenning AS. Effects of high-intensity interval training on cardiometabolic health: a systematic review and meta-analysis of intervention studies. Br J Sports Med. 2017 Mar;51(6):494-503. doi: 10.1136/bjsports-2015-095841. Epub 2016 Oct 20.
Benham JL, Booth JE, Friedenreich CM, Rabi DM, Sigal RJ. Comparative Success of Recruitment Strategies for an Exercise Intervention Trial Among Women With Polycystic Ovary Syndrome: Observational Study. J Med Internet Res. 2021 Mar 30;23(3):e25208. doi: 10.2196/25208.
Other Identifiers
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REB17-1574
Identifier Type: -
Identifier Source: org_study_id
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