University of Calgary Clinical Trials Unit
Calgary, Alberta, T2T 5C7, Canada
NCT Number: NCT03362918
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).
Looking for future studies?
Notify Me18 year–40 year
Female
Interventional
Not applicable
Calgary, Alberta, T2T 5C7, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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.
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.
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).
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.
Time frame: Up to 15 months.
Non-induced embryonic or fetal death or passage of products of conception before 20 weeks gestation.
Time frame: Up to 15 months.
The delivery of a live infant
Time frame: Up to 9 months.
Change in body weight pre- and post-intervention
Time frame: Up to 9 months.
Change in body mass index pre- and post-intervention
Time frame: Up to 9 months.
Change in waist circumference pre- and post-intervention
Time frame: Up to 9 months.
Change in blood pressure pre- and post-intervention
Time frame: Up to 9 months.
Change in hemoglobin A1c pre- and post-intervention
Time frame: Up to 9 months.
Change in fasting glucose pre- and post-intervention
Time frame: Up to 9 months.
Change in fasting insulin pre- and post-intervention
Time frame: Up to 9 months.
Change in HOMA-IR pre- and post-intervention
Time frame: Up to 9 months.
To assess insulin resistance using the updated HOMA-2 model
Time frame: Up to 9 months.
Change in lipid profile pre- and post-intervention
Time frame: Up to 9 months.
Change in liver enzymes pre- and post-intervention
Time frame: Up to 9 months.
Change in cardiorespiratory fitness assessed as maximal oxygen consumption evaluated using a treadmill test and a metabolic cart
Time frame: Up to 15 months.
Change in Health-Related Quality of Life using the PCOS-Q and SF-36
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.
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.
Time frame: Up to enrolment in study.
Participant recruitment will be assessed by recording the number of participants that were initially screened.
Time frame: Up to enrolment in study.
The investigators will document how each participant was recruited (i.e. poster, physician referral, etc.).
Time frame: Up to enrolment in the study.
The investigators will record the number that met all inclusion and exclusion criteria.
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.
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.
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.
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.
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.
Time frame: Up to 9 months.
Pre- and post-intervention stool samples will be assessed with 16S rRNA sequencing.
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.
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.
University of Calgary
Other
The Impact of Continuous Aerobic Exercise and High-Intensity Interval Training on Reproductive Outcomes in Polycystic Ovary Syndrome: A Pilot Randomized Controlled Trial.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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