Back to resultsPolycystic Ovary Syndrome and Exercise
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High Intensity Interval Training
Continuous Aerobic Exercise Training
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility 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:
- 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).
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.
Sites / Locations
- University of Calgary Clinical Trials Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control Group
High-Intensity Interval Training
Continuous Aerobic Exercise Training
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Luteal Phase Length
The luteal phase length is defined as the number of days from ovulation to menses (normal is 12 to 16 days).
Pregnancy
Pregnancy will be confirmed by the presence of a fetal heart beat on a first-trimester ultrasound, ordered by the participant's physician.
Spontaneous Abortions
Non-induced embryonic or fetal death or passage of products of conception before 20 weeks gestation.
Live Births
The delivery of a live infant
Body Weight
Change in body weight pre- and post-intervention
Body Mass Index
Change in body mass index pre- and post-intervention
Waist Circumference
Change in waist circumference pre- and post-intervention
Blood Pressure
Change in blood pressure pre- and post-intervention
Hemoglobin A1c
Change in hemoglobin A1c pre- and post-intervention
Fasting Glucose
Change in fasting glucose pre- and post-intervention
Fasting Insulin
Change in fasting insulin pre- and post-intervention
Homeostatic Model of Insulin Resistance (HOMA-IR)
Change in HOMA-IR pre- and post-intervention
HOMA-2
To assess insulin resistance using the updated HOMA-2 model
Lipids - total cholesterol, LDL, HDL, triglycerides
Change in lipid profile pre- and post-intervention
Liver Enzymes - ALT, GGT
Change in liver enzymes pre- and post-intervention
Cardiorespiratory Fitness
Change in cardiorespiratory fitness assessed as maximal oxygen consumption evaluated using a treadmill test and a metabolic cart
Health-Related Quality of Life
Change in Health-Related Quality of Life using the PCOS-Q and SF-36
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.
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.
Participant Recruitment - Number of Participants Screened
Participant recruitment will be assessed by recording the number of participants that were initially screened.
Participant Recruitment - Recruitment Method
The investigators will document how each participant was recruited (i.e. poster, physician referral, etc.).
Participant Recruitment - Number of Participants That Met Criteria
The investigators will record the number that met all inclusion and exclusion criteria.
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.
Participant Dropout
Dropout will be reported as a percentage of participants that enrolled in the study and did not complete the study.
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.
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.
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.
Change in Gut Microbiota Composition
Pre- and post-intervention stool samples will be assessed with 16S rRNA sequencing.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03362918
Brief Title
Polycystic Ovary Syndrome and Exercise
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
April 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessors will be blind to the allocation of the study participants.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
High-Intensity Interval Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Continuous Aerobic Exercise Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval Training
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Continuous Aerobic Exercise Training
Intervention Description
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 Measure Information:
Title
Ovulation Rate
Description
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.
Time Frame
Up to 9 months.
Secondary Outcome Measure Information:
Title
Hirsutism
Description
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.
Time Frame
Up to 9 months.
Title
Menstrual Cycle Length
Description
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.
Time Frame
Up to 9 months.
Title
Luteal Phase Length
Description
The luteal phase length is defined as the number of days from ovulation to menses (normal is 12 to 16 days).
Time Frame
Up to 9 months.
Title
Pregnancy
Description
Pregnancy will be confirmed by the presence of a fetal heart beat on a first-trimester ultrasound, ordered by the participant's physician.
Time Frame
Up to 15 months.
Title
Spontaneous Abortions
Description
Non-induced embryonic or fetal death or passage of products of conception before 20 weeks gestation.
Time Frame
Up to 15 months.
Title
Live Births
Description
The delivery of a live infant
Time Frame
Up to 15 months.
Title
Body Weight
Description
Change in body weight pre- and post-intervention
Time Frame
Up to 9 months.
Title
Body Mass Index
Description
Change in body mass index pre- and post-intervention
Time Frame
Up to 9 months.
Title
Waist Circumference
Description
Change in waist circumference pre- and post-intervention
Time Frame
Up to 9 months.
Title
Blood Pressure
Description
Change in blood pressure pre- and post-intervention
Time Frame
Up to 9 months.
Title
Hemoglobin A1c
Description
Change in hemoglobin A1c pre- and post-intervention
Time Frame
Up to 9 months.
Title
Fasting Glucose
Description
Change in fasting glucose pre- and post-intervention
Time Frame
Up to 9 months.
Title
Fasting Insulin
Description
Change in fasting insulin pre- and post-intervention
Time Frame
Up to 9 months.
Title
Homeostatic Model of Insulin Resistance (HOMA-IR)
Description
Change in HOMA-IR pre- and post-intervention
Time Frame
Up to 9 months.
Title
HOMA-2
Description
To assess insulin resistance using the updated HOMA-2 model
Time Frame
Up to 9 months.
Title
Lipids - total cholesterol, LDL, HDL, triglycerides
Description
Change in lipid profile pre- and post-intervention
Time Frame
Up to 9 months.
Title
Liver Enzymes - ALT, GGT
Description
Change in liver enzymes pre- and post-intervention
Time Frame
Up to 9 months.
Title
Cardiorespiratory Fitness
Description
Change in cardiorespiratory fitness assessed as maximal oxygen consumption evaluated using a treadmill test and a metabolic cart
Time Frame
Up to 9 months.
Title
Health-Related Quality of Life
Description
Change in Health-Related Quality of Life using the PCOS-Q and SF-36
Time Frame
Up to 15 months.
Title
Obstructive Sleep Apnea
Description
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.
Time Frame
Up to 9 months.
Title
Participant Satisfaction
Description
To assess participant satisfaction with their participation in this study using a questionnaire specifically designed for this study, with higher numbers indicating higher satisfaction.
Time Frame
Up to 9 months.
Title
Participant Recruitment - Number of Participants Screened
Description
Participant recruitment will be assessed by recording the number of participants that were initially screened.
Time Frame
Up to enrolment in study.
Title
Participant Recruitment - Recruitment Method
Description
The investigators will document how each participant was recruited (i.e. poster, physician referral, etc.).
Time Frame
Up to enrolment in study.
Title
Participant Recruitment - Number of Participants That Met Criteria
Description
The investigators will record the number that met all inclusion and exclusion criteria.
Time Frame
Up to enrolment in the study.
Title
Participant Recruitment - Number of Participants That Signed Informed Consent
Description
The investigators will record the number that agreed to participate in the study and signed informed consent.
Time Frame
Up to enrolment in the study.
Title
Participant Dropout
Description
Dropout will be reported as a percentage of participants that enrolled in the study and did not complete the study.
Time Frame
Up to 15 months.
Title
Adherence to Menstrual Cycle Tracking
Description
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.
Time Frame
Up to 9 months.
Title
Adherence to Ovulation Prediction Kit (OPK) Testing
Description
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.
Time Frame
Up to 9 months.
Title
Adherence to Exercise Sessions
Description
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.
Time Frame
Up to 9 months.
Title
Change in Gut Microbiota Composition
Description
Pre- and post-intervention stool samples will be assessed with 16S rRNA sequencing.
Time Frame
Up to 9 months.
Title
Daily Physical Activity Level
Description
All individuals will wear Polar A370 fitness trackers during the intervention phase, and daily steps and kilocalories per day will be recorded.
Time Frame
Up to 9 months.
Title
Physical Activity Enjoyment
Description
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.
Time Frame
Up to 9 months.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald J Sigal, MD, MPH
Organizational Affiliation
University of Calgary, rsigal@ucalgary.ca
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary Clinical Trials Unit
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2T 5C7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Polycystic Ovary Syndrome and Exercise
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