Recruiting

HIIT & Aerobic

Sponsor:

University of Toronto

Code:

NCT07132385

Conditions

Women

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Guidelines-based moderate-intensity continuous exercise

High-intensity interval training

Stretching exercise

Study Details

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

Study ID

NCT07132385

Start date

Sep 1, 2025

Status verified date

Sep, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Guidelines-based moderate-intensity continuous exercise

150 weekly minutes of moderate-intensity aerobic activity

experimental: High-intensity interval training

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

active comparator: Stretching exercise

whole-body stretching

Interventions

Guidelines-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)

High-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.

Stretching exercise

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

Primary outcome measure

  • Intervention Adherence [ Time Frame: End of week 6 ]
  • Enrolment [ Time Frame: End of week 6 ]
  • Study Assessment Adherence [ Time Frame: End of week 6 ]
  • Attrition [ Time Frame: End of week 6 ]
  • Intervention acceptability [ Time Frame: End of week 6 ]

Central Contacts and Locations

Central contacts

Jenna Gillen, PhD

14169783244jenna.gillen@utoronto.ca

Clara Rivaya Salvadores, BKin

4169783244clara.rivayasalvadores@mail.utoronto.ca

Locations

Goldring Centre for High Performance Sport

Recruiting

Toronto, Ontario, Canada, M5S 2C9

Contacts

Jenna Gillen, PhD

4169783244jenna.gillen@utoronto.ca

More Information

Sponsor

University of Toronto

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • menopause
  • perimenopause
  • exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2025-09-09.