Feasibility of Different Types of Exercise Training in Perimenopausal Females

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Participants will be randomized to 1 of 3 groups and complete a 6 week intervention: 1) Moderate intensity continuous training (MICT) following the Health Canada guidelines (Group 1); 2) High-intensity interval training (HIIT) (Group 2); or 3) Stretching (Group 3). Before and after the intervention, participants will complete questionnaires to assess your menopause symptoms, stress levels and quality of life. Before and after the intervention the research team will also assess participants' body composition (fat mass and muscle mass) using a BodPod, and insulin sensitivity using an oral glucose tolerance testing with blood sampling. After the intervention, investigators will also ask that participants complete questionnaires that indicate how easy and enjoyable the intervention was to follow.

Conditions

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Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Guidelines-based moderate-intensity continuous exercise

150 weekly minutes of moderate-intensity aerobic activity

Group Type EXPERIMENTAL

Guidelines-based moderate-intensity continuous exercise

Intervention Type 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

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

Group Type EXPERIMENTAL

High-intensity interval training

Intervention Type 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

whole-body stretching

Group Type ACTIVE_COMPARATOR

Stretching exercise

Intervention Type BEHAVIORAL

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

Interventions

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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)

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Stretching exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No