Polycystic Ovary SyndromeNCT03362918
Polycystic Ovary Syndrome and Exercise
A study testing High Intensity Interval Training and Continuous Aerobic Exercise Training in people with Polycystic Ovary Syndrome, run by University of Calgary at 1 site in Canada.
Trial summary
Polycystic Ovary Syndrome (PCOS) is a common hormonal disorder characterized by oligo-ovulatory menstrual dysfunction, androgen excess and polycystic ovaries. It affects ten to fifteen percent of reproductive-age women and has been associated with complications in reproductive, metabolic and cardiovascular health. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- High Intensity Interval Training and Continuous Aerobic Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 17 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants will be eligible for inclusion if they are females between the ages of 18 and 40 years with a diagnosis of PCOS according to the 2003 revised Rotterdam criteria, confirmed by a qualified member of our research team. Participants will have at least two of the three following criteria:
- 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.
- 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.
- 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).
Who cannot join
- Participants must not have a diagnosis of or clinical evidence of Cushing's syndrome, androgen-secreting tumours, congenital adrenal hyperplasia including classical and non-classical, uncontrolled thyroid dysfunction, diabetes, hemoglobin A1c greater than or equal to 6.5%, hypogonadotropic hypogonadism, premature ovarian insufficiency, or hyperprolactinemia.
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Calgary Clinical Trials Unit
Calgary, Alberta, T2T 5C7
About this study
Official title: The Impact of Continuous Aerobic Exercise and High-Intensity Interval Training on Reproductive Outcomes in Polycystic Ovary Syndrome: A Pilot Randomized Controlled Trial.
Polycystic Ovary Syndrome (PCOS) is a common hormonal disorder characterized by oligo-ovulatory menstrual dysfunction, androgen excess and polycystic ovaries. It affects ten to fifteen percent of reproductive-age women and has been associated with complications in reproductive, metabolic and cardiovascular health. Current Clinical Practice Guidelines suggest exercise and weight loss for PCOS, although their specific roles in improving PCOS-related symptoms are uncertain.
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).
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- High Intensity Interval Training, Continuous Aerobic Exercise Training
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingBehavioural
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 TrainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| High-Intensity Interval Training | Experimental | 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. Receives: Behavioral: High Intensity Interval Training |
| Continuous Aerobic Exercise Training | Experimental | 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. Receives: Behavioral: Continuous Aerobic Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation Rate
The ovulation rate is defined as the number of times a participant ovulates during the intervention period adjusted for the baseline ovulation rate during the run-in phase.
Measured: Up to 9 months.
Secondary outcomes (32)
Hirsutism
This will be assessed using the Ferriman-Gallwey Score, which quantifies hair growth in women with PCOS. Scores range from 0-36, with higher scores indicating more hair growth.
Measured: Up to 9 months.
Menstrual Cycle Length
The menstrual cycle starts on the first day of menses and lasts until menses resumes. A regular menstrual cycle length ranges from 24 to 35 days.
Measured: Up to 9 months.
Luteal Phase Length
The luteal phase length is defined as the number of days from ovulation to menses (normal is 12 to 16 days).
Measured: Up to 9 months.
Pregnancy
Pregnancy will be confirmed by the presence of a fetal heart beat on a first-trimester ultrasound, ordered by the participant's physician.
Measured: Up to 15 months.
Spontaneous Abortions
Non-induced embryonic or fetal death or passage of products of conception before 20 weeks gestation.
Measured: Up to 15 months.
Live Births
The delivery of a live infant
Measured: Up to 15 months.
Body Weight
Change in body weight pre- and post-intervention
Measured: Up to 9 months.
Body Mass Index
Change in body mass index pre- and post-intervention
Measured: Up to 9 months.
Waist Circumference
Change in waist circumference pre- and post-intervention
Measured: Up to 9 months.
Blood Pressure
Change in blood pressure pre- and post-intervention
Measured: Up to 9 months.
Hemoglobin A1c
Change in hemoglobin A1c pre- and post-intervention
Measured: Up to 9 months.
Fasting Glucose
Change in fasting glucose pre- and post-intervention
Measured: Up to 9 months.
Fasting Insulin
Change in fasting insulin pre- and post-intervention
Measured: Up to 9 months.
Homeostatic Model of Insulin Resistance (HOMA-IR)
Change in HOMA-IR pre- and post-intervention
Measured: Up to 9 months.
HOMA-2
To assess insulin resistance using the updated HOMA-2 model
Measured: Up to 9 months.
Lipids - total cholesterol, LDL, HDL, triglycerides
Change in lipid profile pre- and post-intervention
Measured: Up to 9 months.
Liver Enzymes - ALT, GGT
Change in liver enzymes pre- and post-intervention
Measured: Up to 9 months.
Cardiorespiratory Fitness
Change in cardiorespiratory fitness assessed as maximal oxygen consumption evaluated using a treadmill test and a metabolic cart
Measured: Up to 9 months.
Health-Related Quality of Life
Change in Health-Related Quality of Life using the PCOS-Q and SF-36
Measured: Up to 15 months.
Obstructive Sleep Apnea
Change in symptoms of obstructive sleep apnea pre- and post-intervention using the STOP-BANG score. This score has 8 questions, and the likelihood of obstructive sleep apnea increases with a score of 3 or more.
Measured: Up to 9 months.
Participant Satisfaction
To assess participant satisfaction with their participation in this study using a questionnaire specifically designed for this study, with higher numbers indicating higher satisfaction.
Measured: Up to 9 months.
Participant Recruitment - Number of Participants Screened
Participant recruitment will be assessed by recording the number of participants that were initially screened.
Measured: Up to enrolment in study.
Participant Recruitment - Recruitment Method
The investigators will document how each participant was recruited (i.e. poster, physician referral, etc.).
Measured: Up to enrolment in study.
Participant Recruitment - Number of Participants That Met Criteria
The investigators will record the number that met all inclusion and exclusion criteria.
Measured: Up to enrolment in the study.
Participant Recruitment - Number of Participants That Signed Informed Consent
The investigators will record the number that agreed to participate in the study and signed informed consent.
Measured: Up to enrolment in the study.
Participant Dropout
Dropout will be reported as a percentage of participants that enrolled in the study and did not complete the study.
Measured: Up to 15 months.
Adherence to Menstrual Cycle Tracking
Participants will record features of their menstrual cycle daily (menses, spotting, no menstrual bleeding) using a monthly calendar, or phone app. Adherence will be recorded as the percentage of data recorded over the study duration.
Measured: Up to 9 months.
Adherence to Ovulation Prediction Kit (OPK) Testing
Participants will complete the OPK test daily, take a digital photograph of the used test strip and send it to the research team daily. Adherence will be recorded as the percentage completed over the study.
Measured: Up to 9 months.
Adherence to Exercise Sessions
For individuals randomized to the high-intensity training group or the continuous aerobic exercise training group, exercise sessions will be tracked using a Polar heart rate monitor and data will be downloaded weekly at a supervised exercise session. Participants will also log their workouts (type, duration, intensity) in a log book.
Measured: Up to 9 months.
Change in Gut Microbiota Composition
Pre- and post-intervention stool samples will be assessed with 16S rRNA sequencing.
Measured: Up to 9 months.
Daily Physical Activity Level
All individuals will wear Polar A370 fitness trackers during the intervention phase, and daily steps and kilocalories per day will be recorded.
Measured: Up to 9 months.
Physical Activity Enjoyment
Individuals randomized to the exercise groups will complete the Physical Activity Enjoyment Scale during an exercise training session at the beginning of the exercise intervention, at 3 months into the intervention and at 6 months into the intervention.
Measured: Up to 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Jan 2018
- Primary completion1 Oct 2019
- Study completion17 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald J Sigal, MD, MPH, Principal investigator, University of Calgary, rsigal@ucalgary.ca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362918
- Sponsor's protocol ID
- REB17-1574
- Status last verified
- Jul 2020
- First submitted
- 9 Nov 2017
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27233760Sirmans SM, Pate KA. Epidemiology, diagnosis, and management of polycystic ovary syndrome. Clin Epidemiol. 2013 Dec 18;6:1-13. doi: 10.2147/CLEP.S37559.
PubMed 24379699Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
PubMed 15788499Legro 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.
PubMed 24151290Thomson 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.
PubMed 18583464Turan 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.
PubMed 26311969Vizza 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.
PubMed 27175282Aubuchon 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.
PubMed 18555225Nybacka 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.
PubMed 21962963Jedel 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.
PubMed 20943753Thomson 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.
PubMed 20546140Batacan 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.
PubMed 27797726Benham 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.
PubMed 33783363
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Continuous Aerobic Exercise and High-Intensity Interval Training on Reproductive Outcomes in Polycystic Ovary Syndrome: A Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03362918
- Acronym / sponsor ID
- REB17-1574
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Polycystic Ovary Syndrome (PCOS) is a common hormonal disorder characterized by oligo-ovulatory menstrual dysfunction, androgen excess and polycystic ovaries. It affects ten to fifteen percent of reproductive-age women and has been associated with complications in reproductive, metabolic and cardiovascular health. Current Clinical Practice Guidelines suggest exercise and weight loss for PCOS, although their specific roles in improving PCOS-related symptoms are uncertain.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| High-Intensity Interval Training | Experimental | Behavioral: High Intensity Interval TrainingParticipants 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. |
| Continuous Aerobic Exercise Training | Experimental | Behavioral: Continuous Aerobic Exercise TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants will be eligible for inclusion if they are females between the ages of 18 and 40 years with a diagnosis of PCOS according to the 2003 revised Rotterdam criteria, confirmed by a qualified member of our research team. Participants will have at least two of the three following criteria:
Key exclusion criteria (5 listed)
- Participants must not have a diagnosis of or clinical evidence of Cushing's syndrome, androgen-secreting tumours, congenital adrenal hyperplasia including classical and non-classical, uncontrolled thyroid dysfunction, diabetes, hemoglobin A1c greater than or equal to 6.5%, hypogonadotropic hypogonadism, premature ovarian insufficiency, or hyperprolactinemia.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval TrainingThe 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 | Behavioural | High-Intensity Interval Training |
| Continuous Aerobic Exercise TrainingThe 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 | Behavioural | Continuous Aerobic Exercise Training |
Primary outcome
Ovulation Rate
Time frame: Up to 9 months.
The ovulation rate is defined as the number of times a participant ovulates during the intervention period adjusted for the baseline ovulation rate during the run-in phase.
32 secondary outcomes
Hirsutism
Time frame: Up to 9 months.
Menstrual Cycle Length
Time frame: Up to 9 months.
Luteal Phase Length
Time frame: Up to 9 months.
Pregnancy
Time frame: Up to 15 months.
Spontaneous Abortions
Time frame: Up to 15 months.
Live Births
Time frame: Up to 15 months.
Body Weight
Time frame: Up to 9 months.
Body Mass Index
Time frame: Up to 9 months.
Waist Circumference
Time frame: Up to 9 months.
Blood Pressure
Time frame: Up to 9 months.
Hemoglobin A1c
Time frame: Up to 9 months.
Fasting Glucose
Time frame: Up to 9 months.
Fasting Insulin
Time frame: Up to 9 months.
Homeostatic Model of Insulin Resistance (HOMA-IR)
Time frame: Up to 9 months.
HOMA-2
Time frame: Up to 9 months.
Lipids - total cholesterol, LDL, HDL, triglycerides
Time frame: Up to 9 months.
Liver Enzymes - ALT, GGT
Time frame: Up to 9 months.
Cardiorespiratory Fitness
Time frame: Up to 9 months.
Health-Related Quality of Life
Time frame: Up to 15 months.
Obstructive Sleep Apnea
Time frame: Up to 9 months.
Participant Satisfaction
Time frame: Up to 9 months.
Participant Recruitment - Number of Participants Screened
Time frame: Up to enrolment in study.
Participant Recruitment - Recruitment Method
Time frame: Up to enrolment in study.
Participant Recruitment - Number of Participants That Met Criteria
Time frame: Up to enrolment in the study.
Participant Recruitment - Number of Participants That Signed Informed Consent
Time frame: Up to enrolment in the study.
Participant Dropout
Time frame: Up to 15 months.
Adherence to Menstrual Cycle Tracking
Time frame: Up to 9 months.
Adherence to Ovulation Prediction Kit (OPK) Testing
Time frame: Up to 9 months.
Adherence to Exercise Sessions
Time frame: Up to 9 months.
Change in Gut Microbiota Composition
Time frame: Up to 9 months.
Daily Physical Activity Level
Time frame: Up to 9 months.
Physical Activity Enjoyment
Time frame: Up to 9 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Background: PubMed 27233760Lizneva 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.
- Background: PubMed 24379699Sirmans SM, Pate KA. Epidemiology, diagnosis, and management of polycystic ovary syndrome. Clin Epidemiol. 2013 Dec 18;6:1-13. doi: 10.2147/CLEP.S37559.
- Background: PubMed 15788499Ehrmann DA. Polycystic ovary syndrome. N Engl J Med. 2005 Mar 24;352(12):1223-36. doi: 10.1056/NEJMra041536. No abstract available.
- Background: PubMed 24151290Legro 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.
- Background: PubMed 18583464Thomson 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.
- Background: PubMed 26311969Turan 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.
- Background: PubMed 27175282Vizza 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.
- Background: PubMed 18555225Aubuchon 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.
- Background: PubMed 21962963Nybacka 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.
- Background: PubMed 20943753Jedel 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.
- Background: PubMed 20546140Thomson 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.
- Background: PubMed 27797726Batacan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald J Sigal, MD, MPH principal investigator
University of Calgary, rsigal@ucalgary.ca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training and Continuous Aerobic Exercise Training in people with Polycystic Ovary Syndrome, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation Rate (time frame: Up to 9 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362918, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.