An interventional study of Guidelines-based moderate-intensity continuous exercise and High-intensity interval training in Women, sponsored by University of Toronto. Recruiting at 1 site in Canada. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University of Toronto · Not applicable, Interventional, and Prevention
Throughout the menopause transition, women experience many symptoms (i.e., hot flashes, night sweats) that can significantly reduce their quality of life. Moreover, their risk of heart disease increases substantially. The years before menopause called "perimenopause" present a critical window of intervention to alleviate menopause symptoms and improve health outcomes. Our team is therefore interested in comparing the potential benefits of different approaches including following the Health Canada guidelines (i.e., accumulating 150 min of moderate-to-vigorous aerobic physical activity weekly); performing high-intensity interval training (HIIT), which involves alternating periods of intense exercise with periods of rest; or stretching in perimenopause. As a first step towards this goal, this study will assess how easy and enjoyable the interventions are to follow over a 6-week period. The information gained from this study will be used to perform a larger study with enough participants to assess the health and quality of life impacts of adopting these different strategies in perimenopause.
Participants will be randomized to 1 of 3 groups and complete a 6 week intervention: 1) Moderate intensity continuous training (MICT) following the Health Canada guidelines (Group 1); 2) High-intensity interval training (HIIT) (Group 2); or 3) Stretching (Group 3). Before and after the intervention, participants will complete questionnaires to assess your menopause symptoms, stress levels and quality of life. Before and after the intervention the research team will also assess participants' body composition (fat mass and muscle mass) using a BodPod, and insulin sensitivity using an oral glucose tolerance testing with blood sampling. After the intervention, investigators will also ask that participants complete questionnaires that indicate how easy and enjoyable the intervention was to follow.
Exclusion Criteria:
150 weekly minutes of moderate-intensity aerobic activity
Behavioral: Guidelines-based moderate-intensity continuous exercise
Periods of high intensity effort (1-4 min) interspersed with periods of rest (1-3 min)
Behavioral: High-intensity interval training
whole-body stretching
Behavioral: Stretching exercise
Through a combination of exercise trainer-led in-person and virtual sessions, participants will be guided to achieve 150 weekly minutes of moderate-intensity aerobic activity (total intervention is 6 weeks)
Through a combination of exercise trainer-led in-person and virtual sessions, participants will be guided to achieve 75 weekly minutes of high-intensity interval training.
Twice weekly virtual instructor-led whole-body stretching class.
Intervention Adherence
Determined by the percentage of in-person and online sessions attended over those prescribed as well as exercise intensity adherence based on heart rate data collected via Garmin smartwatch
Time frame: End of week 6
Enrolment
Determined by the percentage of participants enrolled in study over those assessed for eligibility
Time frame: End of week 6
Study Assessment Adherence
Determined by the percentage of study assessments completed over those included as part of the study.
Time frame: End of week 6
Attrition
Determined by the percentage of participants who request withdrawal, are lost to follow-up, or experience injury preventing completion of the study over those enrolled
Time frame: End of week 6
Intervention acceptability
Assessed via an intervention-specific researcher-developed questionnaire
Time frame: End of week 6
Systemic insulin resistance
Systemic insulin resistance As assessed by the Matsuda Index calculated from an oral glucose tolerance test
Time frame: 6 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Calculated as: (fasting insulin\*fasting glucose)/22.5
Time frame: Calculated as: (fasting insulin*fasting glucose)/22.5 6 weeks
Cardiorespiratory fitness
Measured as peak volume of oxygen consumption via indirect calorimetry
Time frame: 6 weeks
Body circumferences
Waist and hip circumferences measured by inelastic tape
Time frame: 6 weeks
Whole-body fat and fat free mass
Measured by BodPod
Time frame: 6 weeks
Menopausal symptom presence and severity
Assessed by The Menopause-specific Quality of Life (MENQOL) questionnaire. The 29-item questionnaire measures four domains of symptoms (vasomotor, psychosocial, physical, sexual), capturing both their presence (yes/no) and severity (7-point Likert scale, where a higher score indicates a greater severity).
Time frame: 6 weeks
Sleep
Assessed by sleep time and efficiency via Garmin smartwatch as well as the Pittsburgh Sleep Quality Index (PSQI); score ranges from 0-21, with higher scores indicating poorer sleep quality
Time frame: 6 weeks
Depressive symptoms
Measured by the Patient Health Questionnaire-9 (PHQ-9), where individual scores range from 0-27, and the Beck Depression Inventory, where scores range from 0-63; for both measures, higher scores indicate greater depressive symptom severity
Time frame: 6 weeks
Health-related quality of life
Assessed by RAND-36, where an independent score is provided for 8 scales ranging from 0 to 100, with a higher score indicating better quality of life
Time frame: 6 weeks
Psychosocial stress
Assessed by the perceived stress scale where scores can range from 0 to 40, with higher scores indicating higher perceived stress
Time frame: 6 weeks
Anxiety symptoms
Measured by the Generalized Anxiety Disorder 7-item scale (GAD-7) where scores can range from 0-21, with higher scores indicating greater anxiety
Time frame: 6 weeks
Framingham 10-year risk (%)
Calculated using standardized scoring system
Time frame: 6 weeks
Systolic and Diastolic Blood pressure
Measured after several minutes of supine rest
Time frame: 6 weeks
Heart rate variability
Measured via electrocardiogram
Time frame: 6 weeks
Aortic stiffness (central)
Measured by pulse wave velocity using applanation tonometry
Time frame: 6 weeks
Brachial artery endothelial function
Measured via flow-mediated dilatation test
Time frame: 6 weeks
Dietary intake
Assessed via MyFitness Pal 3-day food records
Time frame: 6 weeks
Plan to share: No
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