Polycystic Ovary Syndrome and Exercise

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Behavioral: High Intensity Interval Training; Behavioral: Continuous Aerobic Exercise Training

• Registration Number: NCT03362918
• Lead Sponsor: 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-05
• Study Start: 2018-01-01
• Primary Completion: 2019-10-01
• Study Completion: 2020-04-17
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-Intensity Interval Training	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.
Continuous Aerobic Exercise Training	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.

Primary Outcome Measures

Name	Time	Method
Ovulation Rate	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

Name	Time	Method
Spontaneous Abortions	Up to 15 months.	Non-induced embryonic or fetal death or passage of products of conception before 20 weeks gestation.
Body Mass Index	Up to 9 months.	Change in body mass index pre- and post-intervention
Health-Related Quality of Life	Up to 15 months.	Change in Health-Related Quality of Life using the PCOS-Q and SF-36
Body Weight	Up to 9 months.	Change in body weight pre- and post-intervention
Cardiorespiratory Fitness	Up to 9 months.	Change in cardiorespiratory fitness assessed as maximal oxygen consumption evaluated using a treadmill test and a metabolic cart
Participant Recruitment - Recruitment Method	Up to enrolment in study.	The investigators will document how each participant was recruited (i.e. poster, physician referral, etc.).
Menstrual Cycle Length	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.
Luteal Phase Length	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).
Blood Pressure	Up to 9 months.	Change in blood pressure pre- and post-intervention
Liver Enzymes - ALT, GGT	Up to 9 months.	Change in liver enzymes pre- and post-intervention
Obstructive Sleep Apnea	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.
Participant Satisfaction	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.
Participant Recruitment - Number of Participants That Met Criteria	Up to enrolment in the study.	The investigators will record the number that met all inclusion and exclusion criteria.
Participant Recruitment - Number of Participants That Signed Informed Consent	Up to enrolment in the study.	The investigators will record the number that agreed to participate in the study and signed informed consent.
Participant Dropout	Up to 15 months.	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	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.
Pregnancy	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.
Hemoglobin A1c	Up to 9 months.	Change in hemoglobin A1c pre- and post-intervention
Fasting Insulin	Up to 9 months.	Change in fasting insulin pre- and post-intervention
HOMA-2	Up to 9 months.	To assess insulin resistance using the updated HOMA-2 model
Hirsutism	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.
Live Births	Up to 15 months.	The delivery of a live infant
Waist Circumference	Up to 9 months.	Change in waist circumference pre- and post-intervention
Fasting Glucose	Up to 9 months.	Change in fasting glucose pre- and post-intervention
Homeostatic Model of Insulin Resistance (HOMA-IR)	Up to 9 months.	Change in HOMA-IR pre- and post-intervention
Lipids - total cholesterol, LDL, HDL, triglycerides	Up to 9 months.	Change in lipid profile pre- and post-intervention
Participant Recruitment - Number of Participants Screened	Up to enrolment in study.	Participant recruitment will be assessed by recording the number of participants that were initially screened.
Adherence to Exercise Sessions	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.
Change in Gut Microbiota Composition	Up to 9 months.	Pre- and post-intervention stool samples will be assessed with 16S rRNA sequencing.
Adherence to Ovulation Prediction Kit (OPK) Testing	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.
Daily Physical Activity Level	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.
Physical Activity Enjoyment	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.

Trial Locations

Locations (1)

University of Calgary Clinical Trials Unit; 🇨🇦 Calgary, Alberta, Canada