WomenPOWERNCT07132385
Feasibility of Different Types of Exercise Training in Perimenopausal Females
A study testing Guidelines-based moderate-intensity continuous exercise, High-intensity interval training and Stretching exercise in people with Women, run by University of Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Women
- What is being tested?
- Guidelines-based moderate-intensity continuous exercise, High-intensity interval training and Stretching exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Goldring Centre for High Performance Sport
Toronto, Ontario, M5S 2C9
Jenna Gillen, PhD, 4169783244, jenna.gillen@utoronto.ca
About this study
Official title: Perimenopause: Window for Exercise and Resilience Pilot Study
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.
Read the 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.
- Conditions
- Women
- Being tested
- Guidelines-based moderate-intensity continuous exercise, High-intensity interval training, Stretching exercise
- Keywords
- menopause, perimenopause, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidelines-based moderate-intensity continuous exerciseBehavioural
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 trainingBehavioural
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 exerciseBehavioural
Twice weekly virtual instructor-led whole-body stretching class.
| Study group | Role | What they receive |
|---|---|---|
| Guidelines-based moderate-intensity continuous exercise | Experimental | 150 weekly minutes of moderate-intensity aerobic activity Receives: Behavioral: Guidelines-based moderate-intensity continuous exercise |
| High-intensity interval training | Experimental | Periods of high intensity effort (1-4 min) interspersed with periods of rest (1-3 min) Receives: Behavioral: High-intensity interval training |
| Stretching exercise | Active comparator | whole-body stretching Receives: Behavioral: Stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End of week 6
Enrolment
Determined by the percentage of participants enrolled in study over those assessed for eligibility
Measured: End of week 6
Study Assessment Adherence
Determined by the percentage of study assessments completed over those included as part of the study.
Measured: End of week 6
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
Measured: End of week 6
Intervention acceptability
Assessed via an intervention-specific researcher-developed questionnaire
Measured: End of week 6
Secondary outcomes (17)
Systemic insulin resistance
Systemic insulin resistance As assessed by the Matsuda Index calculated from an oral glucose tolerance test
Measured: 6 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Calculated as: (fasting insulin*fasting glucose)/22.5
Measured: Calculated as: (fasting insulin*fasting glucose)/22.5 6 weeks
Cardiorespiratory fitness
Measured as peak volume of oxygen consumption via indirect calorimetry
Measured: 6 weeks
Body circumferences
Waist and hip circumferences measured by inelastic tape
Measured: 6 weeks
Whole-body fat and fat free mass
Measured by BodPod
Measured: 6 weeks
Menopausal symptom presence and severity
Assessed by The Menopause-specific Quality of Life (MENQOL) questionnaire. The 29-item questionnaire measures four domains of symptoms (vasomotor, psychosocial, physical, sexual), capturing both their presence (yes/no) and severity (7-point Likert scale, where a higher score indicates a greater severity).
Measured: 6 weeks
Sleep
Assessed by sleep time and efficiency via Garmin smartwatch as well as the Pittsburgh Sleep Quality Index (PSQI); score ranges from 0-21, with higher scores indicating poorer sleep quality
Measured: 6 weeks
Depressive symptoms
Measured by the Patient Health Questionnaire-9 (PHQ-9), where individual scores range from 0-27, and the Beck Depression Inventory, where scores range from 0-63; for both measures, higher scores indicate greater depressive symptom severity
Measured: 6 weeks
Health-related quality of life
Assessed by RAND-36, where an independent score is provided for 8 scales ranging from 0 to 100, with a higher score indicating better quality of life
Measured: 6 weeks
Psychosocial stress
Assessed by the perceived stress scale where scores can range from 0 to 40, with higher scores indicating higher perceived stress
Measured: 6 weeks
Anxiety symptoms
Measured by the Generalized Anxiety Disorder 7-item scale (GAD-7) where scores can range from 0-21, with higher scores indicating greater anxiety
Measured: 6 weeks
Framingham 10-year risk (%)
Calculated using standardized scoring system
Measured: 6 weeks
Systolic and Diastolic Blood pressure
Measured after several minutes of supine rest
Measured: 6 weeks
Heart rate variability
Measured via electrocardiogram
Measured: 6 weeks
Aortic stiffness (central)
Measured by pulse wave velocity using applanation tonometry
Measured: 6 weeks
Brachial artery endothelial function
Measured via flow-mediated dilatation test
Measured: 6 weeks
Dietary intake
Assessed via MyFitness Pal 3-day food records
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Sep 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomenStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Gillen, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132385
- Sponsor's protocol ID
- HSREB56686
- Acronym
- POWER
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perimenopause: Window for Exercise and Resilience Pilot Study
- ClinicalTrials.gov ID
- NCT07132385
- Acronym / sponsor ID
- POWER / HSREB56686
- Conditions
- Women
- Keywords
- menopause, perimenopause, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guidelines-based moderate-intensity continuous exercise | Experimental | Behavioral: Guidelines-based moderate-intensity continuous exercise150 weekly minutes of moderate-intensity aerobic activity |
| High-intensity interval training | Experimental | Behavioral: High-intensity interval trainingPeriods of high intensity effort (1-4 min) interspersed with periods of rest (1-3 min) |
| Stretching exercise | Active comparator | Behavioral: Stretching exercisewhole-body stretching |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guidelines-based moderate-intensity continuous exerciseThrough 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) | Behavioural | Guidelines-based moderate-intensity continuous exercise |
| High-intensity interval trainingThrough 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. | Behavioural | High-intensity interval training |
| Stretching exerciseTwice weekly virtual instructor-led whole-body stretching class. | Behavioural | Stretching exercise |
Primary outcome
Intervention Adherence
Time frame: 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
Time frame: End of week 6
Determined by the percentage of participants enrolled in study over those assessed for eligibility
Study Assessment Adherence
Time frame: End of week 6
Determined by the percentage of study assessments completed over those included as part of the study.
Attrition
Time frame: 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
Time frame: End of week 6
Assessed via an intervention-specific researcher-developed questionnaire
17 secondary outcomes
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
Systolic and Diastolic Blood pressure
Time frame: 6 weeks
Heart rate variability
Time frame: 6 weeks
Aortic stiffness (central)
Time frame: 6 weeks
Brachial artery endothelial function
Time frame: 6 weeks
Dietary intake
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Women
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guidelines-based moderate-intensity continuous exercise, High-intensity interval training and Stretching exercise in people with Women, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenna Gillen, PhD (14169783244, jenna.gillen@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Adherence (time frame: End of week 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.