Feasibility of Different Types of Exercise Training in Perimenopausal Females

NCT07132385 | Recruiting

• 1 other identifier: HSREB56686
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Women

Keywords

menopause; perimenopause; exercise

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (17)

• Systemic insulin resistance

  6 weeks

• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

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

• Cardiorespiratory fitness

  6 weeks

• Body circumferences

  6 weeks

• Whole-body fat and fat free mass

  6 weeks

Study Arms (3)

Guidelines-based moderate-intensity continuous exercise

EXPERIMENTAL

150 weekly minutes of moderate-intensity aerobic activity

Behavioral: Guidelines-based moderate-intensity continuous exercise

High-intensity interval training

EXPERIMENTAL

Periods of high intensity effort (1-4 min) interspersed with periods of rest (1-3 min)

Behavioral: High-intensity interval training

Stretching exercise

ACTIVE COMPARATOR

whole-body stretching

Behavioral: Stretching exercise

Interventions

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)

Guidelines-based moderate-intensity continuous exercise

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.

High-intensity interval training

Stretching exercise BEHAVIORAL

Twice weekly virtual instructor-led whole-body stretching class.

Stretching exercise

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Goldring Centre for High Performance Sport

Toronto, Ontario, M5S 2C9, Canada

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Jenna Gillen, PhD

CONTACT

14169783244; jenna.gillen@utoronto.ca

Clara Rivaya Salvadores, BKin

CONTACT

4169783244; clara.rivayasalvadores@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)