Health TrialsbyHealthPanel

Feasibility of Different Types of Exercise Training in Perimenopausal Females

ConditionWomen
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorUniversity of Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Guidelines-based moderate-intensity continuous exerciseExperimental treatment 1 intervention
Group B: High-intensity interval trainingExperimental treatment 1 intervention
Group C: Stretching exerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intervention Adherence

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

Time frame
End of week 6
2

Enrolment

Determined by the percentage of participants enrolled in study over those assessed for eligibility

Time frame
End of week 6
3

Study Assessment Adherence

Determined by the percentage of study assessments completed over those included as part of the study.

Time frame
End of week 6
4

Attrition

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

Time frame
End of week 6

Secondary outcomes

1

Systemic insulin resistance

Systemic insulin resistance As assessed by the Matsuda Index calculated from an oral glucose tolerance test

Time frame
6 weeks
2

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

Calculated as: (fasting insulin\*fasting glucose)/22.5

Time frame
Calculated as: (fasting insulin*fasting glucose)/22.5 6 weeks
3

Cardiorespiratory fitness

Measured as peak volume of oxygen consumption via indirect calorimetry

Time frame
6 weeks
4

Body circumferences

Waist and hip circumferences measured by inelastic tape

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Toronto

Lead sponsor

Source ClinicalTrials.gov
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