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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guidelines-based moderate-intensity continuous exercise | Experimental | 150 weekly minutes of moderate-intensity aerobic activity |
|
| High-intensity interval training | Experimental | Periods of high intensity effort (1-4 min) interspersed with periods of rest (1-3 min) |
|
| Stretching exercise | Active Comparator | whole-body stretching |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guidelines-based moderate-intensity continuous exercise | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | End of week 6 |
| Enrolment | Determined by the percentage of participants enrolled in study over those assessed for eligibility | End of week 6 |
| Study Assessment Adherence | Determined by the percentage of study assessments completed over those included as part of the study. | 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 | End of week 6 |
| Intervention acceptability | Assessed via an intervention-specific researcher-developed questionnaire | End of week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic insulin resistance | Systemic insulin resistance As assessed by the Matsuda Index calculated from an oral glucose tolerance test | 6 weeks |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenna Gillen, PhD | Contact | 14169783244 | jenna.gillen@utoronto.ca | |
| Clara Rivaya Salvadores, BKin | Contact | 4169783244 | clara.rivayasalvadores@mail.utoronto.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goldring Centre for High Performance Sport | Recruiting | Toronto | Ontario | M5S 2C9 | Canada |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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It is not possible to blind participants to their assigned intervention. Care providers are not involved. The outcome assessors for any assessments involving potential for subjectivity in data collection or analysis will be blinded to group assignment.
| High-intensity interval training | Behavioral | 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. |
|
| Stretching exercise | Behavioral | Twice weekly virtual instructor-led whole-body stretching class. |
|
Calculated as: (fasting insulin*fasting glucose)/22.5
| Calculated as: (fasting insulin*fasting glucose)/22.5 6 weeks |
| Cardiorespiratory fitness | Measured as peak volume of oxygen consumption via indirect calorimetry | 6 weeks |
| Body circumferences | Waist and hip circumferences measured by inelastic tape | 6 weeks |
| Whole-body fat and fat free mass | Measured by BodPod | 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). | 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 | 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 | 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 | 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 | 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 | 6 weeks |
| Framingham 10-year risk (%) | Calculated using standardized scoring system | 6 weeks |
| Systolic and Diastolic Blood pressure | Measured after several minutes of supine rest | 6 weeks |
| Heart rate variability | Measured via electrocardiogram | 6 weeks |
| Aortic stiffness (central) | Measured by pulse wave velocity using applanation tonometry | 6 weeks |
| Brachial artery endothelial function | Measured via flow-mediated dilatation test | 6 weeks |
| Dietary intake | Assessed via MyFitness Pal 3-day food records | 6 weeks |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |