Exercise Interventions for Perimenopausal Symptoms

(POWER Trial)

Overseen By Clara Rivaya Salvadores, BKin

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Toronto

Must not be taking: Blood glucose medications, Exogenous hormones

Disqualifiers: Cardiovascular disease, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different exercise routines to determine which might alleviate perimenopause symptoms, such as hot flashes and night sweats, and reduce heart disease risk. Participants will engage in one of three activities: guidelines-based moderate-intensity continuous exercise (moderate aerobic exercise), high-intensity interval training (short bursts of intense exercise followed by rest), or stretching exercise. The primary goal is to identify which activity is easiest and most enjoyable to maintain over six weeks. Women in perimenopause, experiencing menopause symptoms, and not currently very active may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to explore personalized exercise options that may enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications that affect blood glucose or hormones. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that moderate exercise, such as 150 minutes of aerobic activity each week, is generally safe. It can reduce menopausal symptoms and improve sleep. Studies have found that women who engage in more physical activity experience fewer menopausal symptoms.

High-intensity interval training (HIIT), which involves short bursts of intense exercise followed by rest, is also safe and beneficial for women. HIIT can enhance heart and muscle health, and most women find it manageable. One study found that women adhere to HIIT programs at a high rate, indicating it is easy to maintain.

Overall, both types of exercise are safe and effective for managing health during perimenopause. They are generally well-tolerated by women and positively impact health and wellness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise interventions for perimenopausal symptoms because they offer diverse approaches to manage the condition naturally. Unlike hormone replacement therapy or medications, these exercise protocols focus on physical activity to potentially alleviate symptoms. High-intensity interval training (HIIT) is distinctive for its brief bursts of intense exercise followed by rest, which can improve cardiovascular fitness in less time. Moderate-intensity continuous exercise aligns with established health guidelines, providing a balanced, sustainable routine. Meanwhile, stretching exercises offer a gentle way to enhance flexibility and relieve tension. Each method aims to improve quality of life without the side effects associated with traditional treatments.

What evidence suggests that this trial's exercise interventions could be effective for perimenopausal symptoms?

This trial will compare different exercise interventions for perimenopausal symptoms. Studies have shown that various types of exercise can ease symptoms like hot flashes and improve overall health. Participants may engage in high-intensity interval training (HIIT), which has improved heart and lung health, aided in fat loss, and reduced menopause-related effects. Research indicates that women who do HIIT notice better fitness and strength. Another group will follow guidelines-based moderate-intensity continuous exercise, which evidence suggests can lessen mild to moderate perimenopausal symptoms and improve bone health when combined with other treatments. The trial also includes a stretching exercise arm, which, though less studied for perimenopause, can still increase flexibility and reduce stress. Overall, these exercises may offer various benefits to help manage symptoms and improve quality of life during perimenopause. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for perimenopausal females who are interested in exploring different exercise routines to alleviate menopause symptoms and improve health outcomes. The study seeks participants willing to engage in either high-intensity interval training, moderate-intensity continuous exercise following Health Canada guidelines, or stretching exercises over a 6-week period.

Inclusion Criteria

I am experiencing symptoms like hot flashes, night sweats, and joint stiffness.

I am not very active, my BMI is 25 or higher, and I have a large waist.

I am 40 years old or older.

Exclusion Criteria

I am taking medication that can affect my blood sugar levels.

Pregnant or post-partum <12 months, lactating or breast feeding within 3 months of the study start

Recreational smoking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized into one of three groups: Moderate intensity continuous training, High-intensity interval training, or Stretching, and complete a 6-week intervention

6 weeks

Weekly sessions (in-person and/or online)

Assessment

Before and after the intervention, participants complete questionnaires and undergo assessments for body composition, insulin sensitivity, and other health metrics

1-2 weeks

Follow-up

Participants are monitored for adherence, acceptability, and any changes in health outcomes post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Guidelines-based moderate-intensity continuous exercise
• High-intensity interval training
• Stretching exercise

Trial Overview The study is testing the feasibility of three types of physical activities: high-intensity interval training (HIIT), moderate-intensity continuous training based on Health Canada's guidelines, and stretching exercises. It aims to determine how easy and enjoyable these interventions are for perimenopausal women.

How Is the Trial Designed?

Group I: High-intensity interval training Experimental Treatment 1 Intervention

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

Group II: Guidelines-based moderate-intensity continuous exercise Experimental Treatment 1 Intervention

150 weekly minutes of moderate-intensity aerobic activity

Group III: Stretching exercise Active Control 1 Intervention

whole-body stretching

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12008710/

Impact of Exercise on Perimenopausal Syndrome Exercise has been proven effective in treating mild to moderate perimenopausal symptoms. However, skepticism remains regarding its effectiveness ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07132385

Feasibility of Different Types of Exercise Training in ... Participants will be randomized to 1 of 3 groups and complete a 6 week intervention: 1) Moderate intensity continuous training (MICT) following the Health ...

3. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03243-4

The impact of physical activity and exercise interventions on ... This overview assesses effectiveness of physical activity and exercise interventions targeting women experiencing menopause symptoms.

4. frontiersin.org frontiersin.org/journals/reproductive-health/articles/10.3389/frph.2025.1542746/full

Impact of menopause hormone therapy, exercise, and their ... This review highlights that combining MHT and structured exercise is most effective for enhancing BMD in menopausal women.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6722698/

High Physical Activity Level May Reduce Menopausal ... Nonpharmaceutical intervention such as physical activity was proven to be an effective method of reducing menopausal symptoms, decreasing bone ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1550830723000307

Effects of exercise on sleep in perimenopausal women Exercise can improve sleep quality and insomnia symptoms in perimenopausal women. Fitness Qigong has the most significant effect on sleep.

7. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-023-02347-7

The relationship between physical activity and the severity of ... The severity of menopausal symptoms decreased in participants with higher levels of physical activity (Moderate: Low OR, 0.26; 95% CI, 0.15–0.45 ...

8. physoc.onlinelibrary.wiley.com physoc.onlinelibrary.wiley.com/doi/10.1113/EP092191

The therapeutic role of exercise training during menopause for ... Regular aerobic exercise during early postmenopause may slow vascular decline by improving NO and oestradiol bioavailability, promoting positive vascular ...