Different exercise programs during perimenopause

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Goldring Centre for High Performance Sport
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Jenna Gillen, PhD
• Email: jenna.gillen@utoronto.ca
• Phone: 14169783244

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.