Goldring Centre for High Performance Sport
Toronto, Ontario, M5S 2C9, Canada
Location status: Recruiting
NCT Number: NCT07132385
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.
Interested in participating?
Request Info40 year and older
Female
Interventional
Not applicable
Toronto, Ontario, M5S 2C9, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: End of week 6
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
Determined by the percentage of participants enrolled in study over those assessed for eligibility
Time frame: End of week 6
Determined by the percentage of study assessments completed over those included as part of the study.
Time frame: End of week 6
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
Assessed via an intervention-specific researcher-developed questionnaire
Time frame: 6 weeks
Systemic insulin resistance As assessed by the Matsuda Index calculated from an oral glucose tolerance test
Time frame: Calculated as: (fasting insulin*fasting glucose)/22.5 6 weeks
Calculated as: (fasting insulin*fasting glucose)/22.5
Time frame: 6 weeks
Measured as peak volume of oxygen consumption via indirect calorimetry
Time frame: 6 weeks
Waist and hip circumferences measured by inelastic tape
Time frame: 6 weeks
Measured by BodPod
Time frame: 6 weeks
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
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
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
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
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
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
Calculated using standardized scoring system
Time frame: 6 weeks
Measured after several minutes of supine rest
Time frame: 6 weeks
Measured via electrocardiogram
Time frame: 6 weeks
Measured by pulse wave velocity using applanation tonometry
Time frame: 6 weeks
Measured via flow-mediated dilatation test
Time frame: 6 weeks
Assessed via MyFitness Pal 3-day food records
Contact information is provided by the study sponsor or research team.
Clara Rivaya Salvadores, BKin
CONTACT
Jenna Gillen, PhD
CONTACT
University of Toronto
Other
Perimenopause: Window for Exercise and Resilience Pilot Study
Acronym: POWER
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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