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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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
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
University of Calgary Clinical Trials Unit
Calgary, Alberta, Canada
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.
Time frame: Up to 9 months.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 15 months.
Spontaneous Abortions
Non-induced embryonic or fetal death or passage of products of conception before 20 weeks gestation.
Time frame: Up to 15 months.
Live Births
The delivery of a live infant
Time frame: Up to 15 months.
Body Weight
Change in body weight pre- and post-intervention
Time frame: Up to 9 months.
Body Mass Index
Change in body mass index pre- and post-intervention
Time frame: Up to 9 months.
Waist Circumference
Change in waist circumference pre- and post-intervention
Time frame: Up to 9 months.
Blood Pressure
Change in blood pressure pre- and post-intervention
Time frame: Up to 9 months.
Hemoglobin A1c
Change in hemoglobin A1c pre- and post-intervention
Time frame: Up to 9 months.
Fasting Glucose
Change in fasting glucose pre- and post-intervention
Time frame: Up to 9 months.
Fasting Insulin
Change in fasting insulin pre- and post-intervention
Time frame: Up to 9 months.
Homeostatic Model of Insulin Resistance (HOMA-IR)
Change in HOMA-IR pre- and post-intervention
Time frame: Up to 9 months.
HOMA-2
To assess insulin resistance using the updated HOMA-2 model
Time frame: Up to 9 months.
Lipids - total cholesterol, LDL, HDL, triglycerides
Change in lipid profile pre- and post-intervention
Time frame: Up to 9 months.
Liver Enzymes - ALT, GGT
Change in liver enzymes pre- and post-intervention
Time frame: Up to 9 months.
Cardiorespiratory Fitness
Change in cardiorespiratory fitness assessed as maximal oxygen consumption evaluated using a treadmill test and a metabolic cart
Time frame: Up to 9 months.
Health-Related Quality of Life
Change in Health-Related Quality of Life using the PCOS-Q and SF-36
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to enrolment in study.
Participant Recruitment - Recruitment Method
The investigators will document how each participant was recruited (i.e. poster, physician referral, etc.).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 9 months.
Change in Gut Microbiota Composition
Pre- and post-intervention stool samples will be assessed with 16S rRNA sequencing.
Time frame: 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.
Time frame: 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.
Time frame: Up to 9 months.
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