Perimenopause: Window for Exercise and Resilience Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intervention Adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
High-intensity interval training
Periods of high intensity effort (1-4 min) interspersed with periods of rest (1-3 min)
干预措施: High-intensity interval training (Behavioral)
Stretching exercise
whole-body stretching
干预措施: Stretching exercise (Behavioral)
Guidelines-based moderate-intensity continuous exercise
150 weekly minutes of moderate-intensity aerobic activity
干预措施: Guidelines-based moderate-intensity continuous exercise (Behavioral)
结局指标
主要结局
Intervention Adherence
时间窗: End of week 6
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
Enrolment
时间窗: End of week 6
Determined by the percentage of participants enrolled in study over those assessed for eligibility
Study Assessment Adherence
时间窗: End of week 6
Determined by the percentage of study assessments completed over those included as part of the study.
Attrition
时间窗: End of week 6
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
Intervention acceptability
时间窗: End of week 6
Assessed via an intervention-specific researcher-developed questionnaire
次要结局
- Systemic insulin resistance(6 weeks)
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(Calculated as: (fasting insulin*fasting glucose)/22.5 6 weeks)
- Cardiorespiratory fitness(6 weeks)
- Body circumferences(6 weeks)
- Whole-body fat and fat free mass(6 weeks)
- Menopausal symptom presence and severity(6 weeks)
- Sleep(6 weeks)
- Depressive symptoms(6 weeks)
- Health-related quality of life(6 weeks)
- Psychosocial stress(6 weeks)
- Anxiety symptoms(6 weeks)
- Framingham 10-year risk (%)(6 weeks)
- Heart rate variability(6 weeks)
- Aortic stiffness (central)(6 weeks)
- Brachial artery endothelial function(6 weeks)
- Dietary intake(6 weeks)
- Body circumferences(6 weeks)
- Systemic insulin resistance(6 weeks)
- Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(Calculated as: (fasting insulin*fasting glucose)/22.5 6 weeks)
- Cardiorespiratory fitness(6 weeks)
- Whole-body fat and fat free mass(6 weeks)
- Menopausal symptom presence and severity(6 weeks)
- Sleep(6 weeks)
- Depressive symptoms(6 weeks)
- Health-related quality of life(6 weeks)
- Psychosocial stress(6 weeks)
- Anxiety symptoms(6 weeks)
- Framingham 10-year risk (%)(6 weeks)
- Systolic and Diastolic Blood pressure(6 weeks)
- Heart rate variability(6 weeks)
- Aortic stiffness (central)(6 weeks)
- Brachial artery endothelial function(6 weeks)
- Dietary intake(6 weeks)
研究者
Jenna Gillen
Associate Professor
University of Toronto