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PerimenopauseEPICNCT07272174

Exercise in Perimenopause to Improve Cognitive Health

A study testing Progressive Resistance Training and Balance, Flexibility, and Tone Exercises in people with Perimenopause and Subjective Cognitive Complaints, run by University of British Columbia at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Perimenopause is now considered a possible risk factor for dementia and may contribute to the fact that 2/3 of those living with Alzheimer's disease are females. Indeed, research studies show that middle-aged females demonstrate significant declines in their thinking abilities and detrimental changes in their brains… Read more about this study

Who is it for?
Ages 40 to 55 years, women onlyHealthy volunteers can take part
What is being tested?
Progressive Resistance Training and Balance, Flexibility, and Tone Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteCanada
Study dates
30 Mar 2026to 30 Jan 2027
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 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Are biological females, as assigned at birth
  • Are aged between 40 and 55 years
  • Had at least 1 menstrual period in the last 10 months
  • Are perimenopausal based on STRAW +10 Staging System, or answer "yes" to MQ6 questions of changes in periods, having hot flashes, or vaginal dryness, pain, or sexual concerns
  • Have an intact uterus
  • Have a Montreal Cognitive Assessment (MoCA) score >=26/30 for in-person or >=19/22 for telephone , indicating normal cognition
Show all 11Show fewer
  • Have subjective cognitive complaints defined as responding "yes" to "Do you feel like your memory or thinking is becoming worse?"
  • Completed high school education
  • Read and speak English with acceptable visual and auditory acuity
  • Are able to safely engage in moderate-intensity PRT as indicated by the PAR-Q+; and
  • Are able to provide informed consent.

Who cannot join

  • Are engaged in regular PRT (i.e., 2x/week) in the prior three months
  • Are diagnosed with cognitive impairment or dementia of any type
  • Are at high risk for cardiac complications during exercise
  • Have clinically important peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility
  • Are taking medications that negatively affect cognitive function, such as anticholinergics, major tranquilizers, and anticonvulsants
  • Have a BMI <15 or anorexia nervosa; g) had surgical menopause
Show all 12Show fewer
  • Had endometrial ablation that resulted in the loss of menstruation
  • Have polycystic ovarian syndrome
  • Currently undergoing chemo
  • Are using estrogen-containing contraception in the last 12 months
  • Had premature ovarian failure; or
  • Are already enrolled in a drug or exercise trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Teresa Liu-Ambrose, PhD contact

6046178047

teresa.ambrose@ubc.ca

Canada1 site, 1 recruiting

  • University of British Columbia

    Vancouver, British Columbia, V5Z 1M9

    Teresa Liu-Ambrose, MHK, 604-875-4111 ext. 69059, teresa.ambrose@ubc.ca

    Recruiting

Other trials in Canada

About this study

Official title: Resistance Training and Cognitive Health in Perimenopause

Perimenopause is now considered a possible risk factor for dementia and may contribute to the fact that 2/3 of those living with Alzheimer's disease are females. Indeed, research studies show that middle-aged females demonstrate significant declines in their thinking abilities and detrimental changes in their brains as they go through perimenopause. Thus, perimenopausal females need strategies to bolster their brain health.

The World Health Organization strongly recommends physical activity interventions to reduce the risk of decline in thinking abilities. However, whether exercise can improve thinking abilities and brain health in perimenopausal females has not been examined. Our research aims to address this important knowledge gap in female brain health.

We will study the effects of a 6-month resistance exercise training (e.g., lifting free weights, exercise with weight machine) program on thinking abilities in 50 physically inactive perimenopausal females, aged 40 to 55 years, who are experiencing difficulties with their thinking abilities. In addition to measuring thinking abilities, we will determine if exercise benefits muscle health, heart health, sleep quality, psychological well-being, menopausal symptoms, and quality of life. We will also explore how resistance exercise training improves thinking abilities as such information can lead to new discoveries and therapies for brain health in females.

Read the detailed description
  1. PURPOSE: To determine if progressive resistance training (PRT) can improve cognitive outcomes compared to balance, flexibility, and tone (BAT) exercises in perimenopausal females aged 40-55 years with subjective cognitive complaints.
  2. HYPOTHESIS: At the end of the intervention, PRT will result in an increase in words recalled during the RAVLT 20-minute delay vs no improve in BAT.
  3. JUSTIFICATION: The menopause transition (MT) negatively impacts cognitive function and the brain. The majority of perimenopausal females experiences cognitive difficulties and have subjective cognitive complaints (SCCs). Verbal episodic memory and processing speed are most negatively impacted by the MT. Cognitive and brain changes during the MT can significantly impact career and financial wellbeing. The MT is thus a critical window to intervene for female brain health. Exercise can reduce dementia risk factors and promote cognitive health. No published randomized controlled trials have examined the effect of exercise on cognitive outcomes in perimenopausal females.
  4. OBJECTIVE: To determine if 26 weeks of 2x/week progressive resistance training (PRT) can improve verbal episodic memory performance on the Rey Auditory Verbal Learning Test (RAVLT) compared with balance, flexibility, and tone exercises (BAT) for physically inactive perimenopausal females aged 40-55. Optional Qualitative Component: To assess knowledge and experiences of perimenopause (pre- and post-intervention), expectations of exercise intervention (pre-intervention), and perceived benefits of exercise intervention (post-intervention).
  5. RESEARCH DESIGN:

A 26-week, assessor-blinded, two-arm, proof-of-concept trial with 50 physically inactive perimenopausal females, aged 40 to 55 years, with subjective cognitive complaints. Participants will be randomized 1:1 to PRT or BAT and measured at baseline, 13 weeks, and 26 weeks.

Being tested
Progressive Resistance Training, Balance, Flexibility, and Tone Exercises
Keywords
progressive resistance training, perimenopause

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive Resistance TrainingBehavioural

    Also called PRT

    The sessions will occur in the Exercise Prescription Suite of the Centre for Aging SMART at VCH; this suite is a fully-equipped gym that includes treadmills, bikes, pneumatic resistance training equipment, and free weights. The training stimulus will initially be at 3 sets of 10-15 repetitions with proper form. At week 4, training intensity will progress from 60-82% of predicted 1 repetition maximum (RM) using the 8RM method. Every 4 weeks the 8RM test will be repeated.

  • Balance, Flexibility, and Tone ExercisesBehavioural

    Also called BAT

    Each BAT session will be 1-hr in duration and consist of Pilates mat exercises, Yoga-based poses and breathing, Kegel exercises, stretches, and relaxation techniques (e.g., visualization).

Study groups in NCT07272174
Study groupRoleWhat they receive
Progressive Resistance Training (PRT)ExperimentalEach PRT session will be 1-hr in duration and consists of a warm-up (10 mins), PRT (45 mins), and cool-down (5 mins). 2x/week and group-based.
Receives: Behavioral: Progressive Resistance Training
Balance, Flexibility, and Tone Exercises (BAT)Active comparatorEach BAT session will be 1-hr in duration. 2x/week and group-based.
Receives: Behavioral: Balance, Flexibility, and Tone Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rey Auditory Verbal Learning Test (RAVLT)

    The RAVLT is a valid, reliable, and widely-used instrument of verbal episodic memory and learning, with normative values.

    Measured: Baseline, 13 weeks, 26 weeks

Secondary outcomes (36)

  1. NIH TB Cognitive Battery - Flanker Test

    A measure of executive functions

    Measured: Baseline, 13 weeks, 26 weeks

  2. NIH TB Cognitive Battery - Dimensional Change Card Sort Test

    A measure of executive functions

    Measured: Baseline, 13 weeks, 26 weeks

  3. NIH TB Cognitive Battery - Picture Sequence Memory Test

    A measure of visual episodic memory

    Measured: Baseline, 13 weeks, 26 weeks

  4. NIH TB Cognitive Battery - List Sorting Test

    A measure of working memory

    Measured: Baseline, 13 weeks, 26 weeks

  5. NIH TB Cognitive Battery - Pattern Comparison Processing Speed Test

    A measure of processing speed

    Measured: Baseline, 13 weeks, 26 weeks

  6. Everyday Memory Questionnaire

    A subjective measure of memory failure in everyday life

    Measured: Baseline, 13 weeks, 26 weeks

  7. Muscle strength of quads

    Muscle strength measure by isokinetic dynamometer

    Measured: Baseline, 13 weeks, 26 weeks

  8. Peripheral QCT of the tibia

    A measure of bone and muscle health

    Measured: Baseline, 13 weeks, 26 weeks

  9. Blood pressure

    Blood pressure - systolic and diastolic

    Measured: Baseline, 13 weeks, 26 weeks

  10. Lipid panel

    Lipid levels

    Measured: Baseline, 26 weeks

  11. Hemoglobin A1-C

    Average blood sugar levels

    Measured: Baseline, 26 weeks

  12. C-reactive protein

    Measure of inflammation

    Measured: Baseline, 26 weeks

  13. Health resource utilization

    Cost of health resource used

    Measured: Baseline, 13 weeks, 26 weeks

  14. Carotid-femoral pulse wave velocity

    Arterial stiffness

    Measured: Baseline, 13 weeks, 26 weeks

  15. Pittsburgh Sleep Quality Index

    Subjective sleep quality

    Measured: Baseline, 13 weeks, 26 weeks

  16. Actigraph

    Using actigraphy data, quantify sleep quality (e.g., duration, efficiency, fragmentation).

    Measured: Baseline, 13 weeks, 26 weeks

  17. Actigraph

    Using actigraphy data, quantify physical activity (e.g., intensity and minutes)

    Measured: Baseline, 13 weeks, 26 weeks

  18. Actigraph

    Using actigraphy data, quantify sedentary behaviour (minutes)

    Measured: Baseline, 13 weeks, 26 weeks

  19. Fatigue Severity Scale

    Subjective fatigue

    Measured: Baseline, 13 weeks, 26 weeks

  20. PHQ-9

    Depression severity

    Measured: Baseline, 13 weeks, 26 weeks

  21. GAD-7

    Generalized anxiety disorder

    Measured: Baseline, 13 weeks, 26 weeks

  22. Menopause Rating Scale

    Menopause symptoms

    Measured: Baseline, 13 weeks, 26 weeks

  23. EuroQol-5 Domain-5 Level

    Quality of life

    Measured: Baseline, 13 weeks, 26 weeks

  24. International Physical Activity Questionnaire

    Physical activity

    Measured: Every 30 days over 26 weeks

  25. DEXA

    Lean mass

    Measured: Baseline, 13 weeks, 26 weeks

  26. DEXA

    Body fat

    Measured: Baseline, 13 weeks, 26 weeks

  27. DEXA

    Appendicular Skeletal Muscle Mass Index (ASMI); a measure of sarcopenia

    Measured: Baseline, 13 weeks, 26 weeks

  28. Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) Diet score

    Diet

    Measured: Baseline, 13 weeks, 26 weeks

  29. Processing Speed by smartphone

    Processing Speed

    Measured: Baseline, 13 weeks, 26 weeks

  30. Memory by smartphone

    Memory

    Measured: Baseline, 13 weeks, 26 weeks

  31. Productivity Questionnaire

    Measure of work productivity

    Measured: Baseline, 13 weeks, 26 weeks

  32. Brain-Derived Neurotrophic Factor

    Neurotrophic Factor

    Measured: Baseline, 26 weeks

  33. IGF-1

    Neurotrophic Factor

    Measured: Baseline, 26 weeks

  34. Optional Qualitative Interviews

    The interviews will involve questions about participants' experiences and impact of perimenopause in their daily lives, their expectations of an exercise intervention, and perceived benefits of group-based exercise training

    Measured: Baseline, 26 weeks

  35. Optional Measure: Muscle Health

    Myosteatosis measured by Upright Open Magnetic Resonance Imaging (UO-MRI) of the mid-thigh and lower leg (dominant)

    Measured: Baseline, 26 weeks

  36. Optional Measure: Cerebral Oxygenation

    Measured by the functional near-infrared spectroscopy (fNIRS)

    Measured: Baseline, 13 weeks, 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start30 Mar 2026
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion30 Jan 2027 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07272174
Sponsor's protocol ID
H25-01552
Acronym
EPIC
Status last verified
Oct 2026
First submitted
19 Nov 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Progressive Resistance Training and Balance, Flexibility, and Tone Exercises in people with Perimenopause and Subjective Cognitive Complaints, run by University of British Columbia 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 11 inclusion and 12 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 20 Oct 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 Teresa Liu-Ambrose, PhD (6046178047, teresa.ambrose@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rey Auditory Verbal Learning Test (RAVLT) (time frame: Baseline, 13 weeks, 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07272174.

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 20 Oct 2026.

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