Feasibility of Different Types of Exercise Training in Perimenopausal Females

Official title

Perimenopause: Window for Exercise and Resilience Pilot Study

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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)
• 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.
• Behavioral Stretching exercise
  Twice weekly virtual instructor-led whole-body stretching class.

Primary outcome measures

• Intervention Adherence [Time frame: End of week 6]
• Enrolment [Time frame: End of week 6]
• Study Assessment Adherence [Time frame: End of week 6]
• Attrition [Time frame: End of week 6]
• Intervention acceptability [Time frame: End of week 6]

Secondary outcome measures (12)

• Systemic insulin resistance [Time frame: 6 weeks]
• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [Time frame: Calculated as: (fasting insulin*fasting glucose)/22.5 6 weeks]
• Cardiorespiratory fitness [Time frame: 6 weeks]
• Body circumferences [Time frame: 6 weeks]
• Whole-body fat and fat free mass [Time frame: 6 weeks]
• Menopausal symptom presence and severity [Time frame: 6 weeks]
• Sleep [Time frame: 6 weeks]
• Depressive symptoms [Time frame: 6 weeks]
• Health-related quality of life [Time frame: 6 weeks]
• Psychosocial stress [Time frame: 6 weeks]
• Anxiety symptoms [Time frame: 6 weeks]
• Framingham 10-year risk (%) [Time frame: 6 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Canada · 1 center

• Goldring Centre for High Performance Sport — Toronto

Identifiers

NCT: NCT07132385 · HSREB56686

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗