Feasibility of Different Types of Exercise Training in Perimenopausal Females

What this trial studies

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.

Conditions in scope

• Women

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)
• 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.

Who can join

Women only · Ages 40 Years and up

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)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-09-01
• Primary completion: 2026-06-30
• Last update posted: 2025-09-09
• First posted: 2025-08-20

Sponsor & contact

Lead sponsor: University of Toronto (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• 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

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.