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NCT Number: NCT07132385

Feasibility of Different Types of Exercise Training in Perimenopausal Females

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.

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S 2C9, Canada

Location status: Recruiting

Location contact

Jenna Gillen, PhD

CONTACT

[email protected]

4169783244

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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.

Primary outcomes

  1. Intervention Adherence

    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

  2. Enrolment

    Time frame: End of week 6

    Determined by the percentage of participants enrolled in study over those assessed for eligibility

  3. Study Assessment Adherence

    Time frame: End of week 6

    Determined by the percentage of study assessments completed over those included as part of the study.

  4. Attrition

    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

  5. Intervention acceptability

    Time frame: End of week 6

    Assessed via an intervention-specific researcher-developed questionnaire

Secondary outcomes

  1. Systemic insulin resistance

    Time frame: 6 weeks

    Systemic insulin resistance As assessed by the Matsuda Index calculated from an oral glucose tolerance test

  2. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    Time frame: Calculated as: (fasting insulin*fasting glucose)/22.5 6 weeks

    Calculated as: (fasting insulin*fasting glucose)/22.5

  3. Cardiorespiratory fitness

    Time frame: 6 weeks

    Measured as peak volume of oxygen consumption via indirect calorimetry

  4. Body circumferences

    Time frame: 6 weeks

    Waist and hip circumferences measured by inelastic tape

  5. Whole-body fat and fat free mass

    Time frame: 6 weeks

    Measured by BodPod

  6. Menopausal symptom presence and severity

    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).

  7. Sleep

    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

  8. Depressive symptoms

    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

  9. Health-related quality of life

    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

  10. Psychosocial stress

    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

  11. Anxiety symptoms

    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

  12. Framingham 10-year risk (%)

    Time frame: 6 weeks

    Calculated using standardized scoring system

  13. Systolic and Diastolic Blood pressure

    Time frame: 6 weeks

    Measured after several minutes of supine rest

  14. Heart rate variability

    Time frame: 6 weeks

    Measured via electrocardiogram

  15. Aortic stiffness (central)

    Time frame: 6 weeks

    Measured by pulse wave velocity using applanation tonometry

  16. Brachial artery endothelial function

    Time frame: 6 weeks

    Measured via flow-mediated dilatation test

  17. Dietary intake

    Time frame: 6 weeks

    Assessed via MyFitness Pal 3-day food records

Study contacts

Contact information is provided by the study sponsor or research team.

Clara Rivaya Salvadores, BKin

CONTACT

[email protected]

4169783244

Jenna Gillen, PhD

CONTACT

[email protected]

14169783244

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

Perimenopause: Window for Exercise and Resilience Pilot Study

Acronym: POWER

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2025
Registry last updated
Sep 9, 2025

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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