Women
Conditions
Keywords
menopause, perimenopause, exercise
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALGuidelines-based moderate-intensity continuous 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)
BEHAVIORALHigh-intensity interval training
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.
BEHAVIORALStretching exercise
Twice weekly virtual instructor-led whole-body stretching class.
Sponsors
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biological females in early and late perimenopause. Menopausal stage will be defined according to the Stages of Reproductive Aging Workshop +10 (STRAW+10). According to STRAW+10, perimenopause is characterized by menstrual cycle irregularity, specifically defined as having bleeding in the previous 12 months but at least a 7-day difference from usual menstrual cycle length * Experiencing menopause symptoms (e.g., hot flashes, night sweats, joint stiffness) * Aged 40 years or older * Multiple risk factors for cardiometabolic disease, namely being sedentary (\<30 min of moderate-vigorous physical activity/week), having a BMI ≥25 kg/m2, and a waist circumference indicative of abdominal obesity, specific to BMI (e.g., BMI 25-29.9: WC: 90cm; BMI 30-34.9: WC: 105cm; BMI 35-35.9: WC:115cm).
Exclusion criteria
* History of reproductive surgeries including oophorectomy, hysterectomy, ablation or gender-affirming. * Diagnosis of cardiovascular disease, type 2 diabetes, non-alcoholic fatty liver disease, cancer (except for non-melanoma skin cancer), respiratory disease (e.g., Chronic Obstructive Pulmonary Disease or severe or uncontrolled asthma), uncontrolled hyper- or hypogonadism (change in medication or dosage in last 6 months and with major symptoms), and/or Polycystic Ovary Syndrome * Major signs or symptoms (regardless of known diagnosis) of cardiovascular diseases, diabetes, or renal disease * The use of medication that could impact blood glucose * Pregnant or post-partum \<12 months, lactating or breast feeding within 3 months of the start of study * Recreational smoking (e.g., tobacco, smoking) * Actively engaging in a low-carbohydrate diet (e.g., ketogenic, Atkins) * Using transdermal hormones, taking exogenous hormones, or receiving exogenous hormones from other means (e.g., intrauterine device) * Significant weight loss (i.e., \>5 kg) in past 3 months or currently taking weight loss medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Adherence | 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 |
| Enrolment | End of week 6 | Determined by the percentage of participants enrolled in study over those assessed for eligibility |
| Study Assessment Adherence | End of week 6 | Determined by the percentage of study assessments completed over those included as part of the study. |
| Attrition | 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 |
| Intervention acceptability | End of week 6 | Assessed via an intervention-specific researcher-developed questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic insulin resistance | 6 weeks | Systemic insulin resistance As assessed by the Matsuda Index calculated from an oral glucose tolerance test |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Calculated as: (fasting insulin*fasting glucose)/22.5 6 weeks | Calculated as: (fasting insulin\*fasting glucose)/22.5 |
| Cardiorespiratory fitness | 6 weeks | Measured as peak volume of oxygen consumption via indirect calorimetry |
| Body circumferences | 6 weeks | Waist and hip circumferences measured by inelastic tape |
| Whole-body fat and fat free mass | 6 weeks | Measured by BodPod |
| Menopausal symptom presence and severity | 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). |
| Sleep | 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 |
| Depressive symptoms | 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 |
| Health-related quality of life | 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 |
| Psychosocial stress | 6 weeks | Assessed by the perceived stress scale where scores can range from 0 to 40, with higher scores indicating higher perceived stress |
| Anxiety symptoms | 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 |
| Framingham 10-year risk (%) | 6 weeks | Calculated using standardized scoring system |
| Systolic and Diastolic Blood pressure | 6 weeks | Measured after several minutes of supine rest |
| Heart rate variability | 6 weeks | Measured via electrocardiogram |
| Aortic stiffness (central) | 6 weeks | Measured by pulse wave velocity using applanation tonometry |
| Brachial artery endothelial function | 6 weeks | Measured via flow-mediated dilatation test |
| Dietary intake | 6 weeks | Assessed via MyFitness Pal 3-day food records |
Countries
Canada
Contacts
CONTACTJenna Gillen, PhD
CONTACTClara Rivaya Salvadores, BKin
Outcome results
None listed