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Trial record 20 of 101 for:    High Intensity Interval Training | Recruiting, Not yet recruiting, Available Studies

Polycystic Ovary Syndrome and Exercise

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ClinicalTrials.gov Identifier: NCT03362918
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Calgary

Brief 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. 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).


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Behavioral: High Intensity Interval Training Behavioral: Continuous Aerobic Exercise Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessors will be blind to the allocation of the study participants.
Primary Purpose: Treatment
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.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 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.

Experimental: 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.
Behavioral: 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


Experimental: 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.
Behavioral: 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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hirsutism [ Time Frame: Up to 9 months. ]
    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.

  2. Menstrual Cycle Length [ Time Frame: Up to 9 months. ]
    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.

  3. Luteal Phase Length [ Time Frame: Up to 9 months. ]
    The luteal phase length is defined as the number of days from ovulation to menses (normal is 12 to 16 days).

  4. Pregnancy [ Time Frame: Up to 15 months. ]
    Pregnancy will be confirmed by the presence of a fetal heart beat on a first-trimester ultrasound, ordered by the participant's physician.

  5. Spontaneous Abortions [ Time Frame: Up to 15 months. ]
    Non-induced embryonic or fetal death or passage of products of conception before 20 weeks gestation.

  6. Live Births [ Time Frame: Up to 15 months. ]
    The delivery of a live infant

  7. Body Weight [ Time Frame: Up to 9 months. ]
    Change in body weight pre- and post-intervention

  8. Body Mass Index [ Time Frame: Up to 9 months. ]
    Change in body mass index pre- and post-intervention

  9. Waist Circumference [ Time Frame: Up to 9 months. ]
    Change in waist circumference pre- and post-intervention

  10. Blood Pressure [ Time Frame: Up to 9 months. ]
    Change in blood pressure pre- and post-intervention

  11. Hemoglobin A1c [ Time Frame: Up to 9 months. ]
    Change in hemoglobin A1c pre- and post-intervention

  12. Fasting Glucose [ Time Frame: Up to 9 months. ]
    Change in fasting glucose pre- and post-intervention

  13. Fasting Insulin [ Time Frame: Up to 9 months. ]
    Change in fasting insulin pre- and post-intervention

  14. Homeostatic Model of Insulin Resistance (HOMA-IR) [ Time Frame: Up to 9 months. ]
    Change in HOMA-IR pre- and post-intervention

  15. HOMA-2 [ Time Frame: Up to 9 months. ]
    To assess insulin resistance using the updated HOMA-2 model

  16. Lipids - total cholesterol, LDL, HDL, triglycerides [ Time Frame: Up to 9 months. ]
    Change in lipid profile pre- and post-intervention

  17. Liver Enzymes - ALT, GGT [ Time Frame: Up to 9 months. ]
    Change in liver enzymes pre- and post-intervention

  18. Cardiorespiratory Fitness [ Time Frame: Up to 9 months. ]
    Change in cardiorespiratory fitness assessed as maximal oxygen consumption evaluated using a treadmill test and a metabolic cart

  19. Health-Related Quality of Life [ Time Frame: Up to 15 months. ]
    Change in Health-Related Quality of Life using the PCOS-Q and SF-36

  20. Obstructive Sleep Apnea [ Time Frame: Up to 9 months. ]
    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.

  21. Participant Satisfaction [ Time Frame: Up to 9 months. ]
    To assess participant satisfaction with their participation in this study using a questionnaire specifically designed for this study, with higher numbers indicating higher satisfaction.

  22. Participant Recruitment - Number of Participants Screened [ Time Frame: Up to enrolment in study. ]
    Participant recruitment will be assessed by recording the number of participants that were initially screened.

  23. Participant Recruitment - Recruitment Method [ Time Frame: Up to enrolment in study. ]
    The investigators will document how each participant was recruited (i.e. poster, physician referral, etc.).

  24. Participant Recruitment - Number of Participants That Met Criteria [ Time Frame: Up to enrolment in the study. ]
    The investigators will record the number that met all inclusion and exclusion criteria.

  25. Participant Recruitment - Number of Participants That Signed Informed Consent [ Time Frame: Up to enrolment in the study. ]
    The investigators will record the number that agreed to participate in the study and signed informed consent.

  26. Participant Dropout [ Time Frame: Up to 15 months. ]
    Dropout will be reported as a percentage of participants that enrolled in the study and did not complete the study.

  27. Adherence to Menstrual Cycle Tracking [ Time Frame: Up to 9 months. ]
    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.

  28. Adherence to Ovulation Prediction Kit (OPK) Testing [ Time Frame: Up to 9 months. ]
    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.

  29. Adherence to Exercise Sessions [ Time Frame: Up to 9 months. ]
    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.

  30. Change in Gut Microbiota Composition [ Time Frame: Up to 9 months. ]
    Pre- and post-intervention stool samples will be assessed with 16S rRNA sequencing.

  31. Daily Physical Activity Level [ Time Frame: Up to 9 months. ]
    All individuals will wear Polar A370 fitness trackers during the intervention phase, and daily steps and kilocalories per day will be recorded.

  32. Physical Activity Enjoyment [ Time Frame: Up to 9 months. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362918


Contacts
Contact: Jamie L Benham, MD 4039558325 jlbenham@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Clinical Trials Unit Recruiting
Calgary, Alberta, Canada, T2T 5C7
Contact: Jamie L Benham, MD    4039558325    jlbenham@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Ronald J Sigal, MD, MPH University of Calgary, rsigal@ucalgary.ca

Publications:

Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT03362918     History of Changes
Other Study ID Numbers: REB17-1574
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases