Feasibility of High-Intensity Interval Training, Moderate-Intensity Continuous Training, and Stretching in Perimenopausal Females

Not Applicable

Not yet recruiting

• Conditions: Women

• Registration Number: NCT07132385
• Lead Sponsor: University of Toronto

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. We will use the information gained from this study 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, you will complete questionnaires to assess your menopause symptoms, stress levesl and quality of life. Before and after the intervention we will also assess your 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, we will also ask that you complete questionnaires that indicate how easy and enjoyable the intervention was to follow.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Study Start: 2025-09-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Goldring Centre for High Performance Sport; 🇨🇦 Toronto, Ontario, Canada