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.
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
- Conditions the study is for
- Perimenopause, Subjective Cognitive Complaints
- What is being tested?
- Progressive Resistance Training and Balance, Flexibility, and Tone Exercises
- Type of treatment
- Lifestyle or therapy programme
- 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
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
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- 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
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- 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.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
Teresa Liu-Ambrose, MHK, 604-875-4111 ext. 69059, teresa.ambrose@ubc.ca
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
- 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.
- 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.
- 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.
- 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).
- 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.
- Conditions
- Perimenopause, Subjective Cognitive Complaints
- 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 group | Role | What they receive |
|---|---|---|
| Progressive Resistance Training (PRT) | Experimental | Each 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 comparator | Each 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.
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)
NIH TB Cognitive Battery - Flanker Test
A measure of executive functions
Measured: Baseline, 13 weeks, 26 weeks
NIH TB Cognitive Battery - Dimensional Change Card Sort Test
A measure of executive functions
Measured: Baseline, 13 weeks, 26 weeks
NIH TB Cognitive Battery - Picture Sequence Memory Test
A measure of visual episodic memory
Measured: Baseline, 13 weeks, 26 weeks
NIH TB Cognitive Battery - List Sorting Test
A measure of working memory
Measured: Baseline, 13 weeks, 26 weeks
NIH TB Cognitive Battery - Pattern Comparison Processing Speed Test
A measure of processing speed
Measured: Baseline, 13 weeks, 26 weeks
Everyday Memory Questionnaire
A subjective measure of memory failure in everyday life
Measured: Baseline, 13 weeks, 26 weeks
Muscle strength of quads
Muscle strength measure by isokinetic dynamometer
Measured: Baseline, 13 weeks, 26 weeks
Peripheral QCT of the tibia
A measure of bone and muscle health
Measured: Baseline, 13 weeks, 26 weeks
Blood pressure
Blood pressure - systolic and diastolic
Measured: Baseline, 13 weeks, 26 weeks
Lipid panel
Lipid levels
Measured: Baseline, 26 weeks
Hemoglobin A1-C
Average blood sugar levels
Measured: Baseline, 26 weeks
C-reactive protein
Measure of inflammation
Measured: Baseline, 26 weeks
Health resource utilization
Cost of health resource used
Measured: Baseline, 13 weeks, 26 weeks
Carotid-femoral pulse wave velocity
Arterial stiffness
Measured: Baseline, 13 weeks, 26 weeks
Pittsburgh Sleep Quality Index
Subjective sleep quality
Measured: Baseline, 13 weeks, 26 weeks
Actigraph
Using actigraphy data, quantify sleep quality (e.g., duration, efficiency, fragmentation).
Measured: Baseline, 13 weeks, 26 weeks
Actigraph
Using actigraphy data, quantify physical activity (e.g., intensity and minutes)
Measured: Baseline, 13 weeks, 26 weeks
Actigraph
Using actigraphy data, quantify sedentary behaviour (minutes)
Measured: Baseline, 13 weeks, 26 weeks
Fatigue Severity Scale
Subjective fatigue
Measured: Baseline, 13 weeks, 26 weeks
PHQ-9
Depression severity
Measured: Baseline, 13 weeks, 26 weeks
GAD-7
Generalized anxiety disorder
Measured: Baseline, 13 weeks, 26 weeks
Menopause Rating Scale
Menopause symptoms
Measured: Baseline, 13 weeks, 26 weeks
EuroQol-5 Domain-5 Level
Quality of life
Measured: Baseline, 13 weeks, 26 weeks
International Physical Activity Questionnaire
Physical activity
Measured: Every 30 days over 26 weeks
DEXA
Lean mass
Measured: Baseline, 13 weeks, 26 weeks
DEXA
Body fat
Measured: Baseline, 13 weeks, 26 weeks
DEXA
Appendicular Skeletal Muscle Mass Index (ASMI); a measure of sarcopenia
Measured: Baseline, 13 weeks, 26 weeks
Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) Diet score
Diet
Measured: Baseline, 13 weeks, 26 weeks
Processing Speed by smartphone
Processing Speed
Measured: Baseline, 13 weeks, 26 weeks
Memory by smartphone
Memory
Measured: Baseline, 13 weeks, 26 weeks
Productivity Questionnaire
Measure of work productivity
Measured: Baseline, 13 weeks, 26 weeks
Brain-Derived Neurotrophic Factor
Neurotrophic Factor
Measured: Baseline, 26 weeks
IGF-1
Neurotrophic Factor
Measured: Baseline, 26 weeks
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
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
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.
- First posted9 Dec 2025
- Study start30 Mar 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health Research Institute
- Responsible party
- Principal investigator, Teresa Liu-Ambrose, University of British Columbia
- Investigators
- Teresa Liu-Ambrose, PhD, Principal investigator, University of British Columbia
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