Different exercise programs during perimenopause
Perimenopause: Window for Exercise and Resilience Pilot Study
Over six weeks, this trial will try following Health Canada exercise guidelines, doing high-intensity interval training (HIIT), or doing stretching to see which is easiest and most enjoyable for women in perimenopause who have menopause symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | University of Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07132385 on ClinicalTrials.gov |
What this trial studies
Participants are randomized to one of three six-week interventions: guideline-based moderate-intensity continuous training, high-intensity interval training (HIIT), or stretching. Before and after the intervention, researchers collect questionnaires on menopause symptoms, stress, and quality of life, measure body composition with a BodPod, and test insulin sensitivity with an oral glucose tolerance test and blood sampling. Adherence and participant-reported ease and enjoyment of the assigned program are recorded after the intervention. The results will inform design and selection of interventions for a larger trial targeting symptom relief and cardiometabolic health in perimenopause.
Who should consider this trial
Good fit: Biological females aged 40 or older in early or late perimenopause who are experiencing menopause symptoms, are sedentary (<30 minutes moderate-to-vigorous activity per week), have BMI ≥25 kg/m2, and have abdominal obesity as defined by the protocol.
Not a fit: People who have had reproductive surgeries (e.g., hysterectomy or oophorectomy), existing cardiovascular disease or type 2 diabetes, or who do not meet the sedentary/overweight abdominal obesity criteria are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the study could identify which type of exercise is most acceptable and likely to be continued, helping reduce menopause symptoms and improve cardiometabolic health during perimenopause.
How similar studies have performed: Previous research shows exercise can help menopausal symptoms and that HIIT improves fitness and insulin sensitivity in other populations, but direct head-to-head comparisons specifically in perimenopausal women are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- Goldring Centre for High Performance Sport — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Jenna Gillen, PhD
- Email: jenna.gillen@utoronto.ca
- Phone: 14169783244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.