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Bewegen in de perimenopauze om de cognitieve gezondheid te verbeteren (EPIC)

16 oktober 2026 bijgewerkt door: Teresa Liu-Ambrose, University of British Columbia

Weerstandstraining en Cognitieve Gezondheid in de Perimenopauze

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  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.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Werving
        • University of British Columbia
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 55 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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
  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Progressive Resistance Training (PRT)

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.
Gedragsmatig: Progressive Resistance Training

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.

Andere namen:
  • PRT
Actieve vergelijker: Balance, Flexibility, and Tone Exercises (BAT)

Each BAT session will be 1-hr in duration. 2x/week and group-based.
Gedragsmatig: Balance, Flexibility, and Tone Exercises

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).

Andere namen:
  • KNUPPEL

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rey Auditory Verbal Learning Test (RAVLT)
Tijdsspanne: Baseline, 13 weeks, 26 weeks

The RAVLT is a valid, reliable, and widely-used instrument of verbal episodic memory and learning, with normative values.
Baseline, 13 weeks, 26 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
NIH TB Cognitive Battery - Flanker Test
Tijdsspanne: Baseline, 13 weeks, 26 weeks

A measure of executive functions
Baseline, 13 weeks, 26 weeks
NIH TB Cognitive Battery - Dimensional Change Card Sort Test
Tijdsspanne: Baseline, 13 weeks, 26 weeks

A measure of executive functions
Baseline, 13 weeks, 26 weeks
NIH TB Cognitive Battery - Picture Sequence Memory Test
Tijdsspanne: Baseline, 13 weeks, 26 weeks

A measure of visual episodic memory
Baseline, 13 weeks, 26 weeks
NIH TB Cognitive Battery - List Sorting Test
Tijdsspanne: Baseline, 13 weeks, 26 weeks

A measure of working memory
Baseline, 13 weeks, 26 weeks
NIH TB Cognitive Battery - Pattern Comparison Processing Speed Test
Tijdsspanne: Baseline, 13 weeks, 26 weeks

A measure of processing speed
Baseline, 13 weeks, 26 weeks
Everyday Memory Questionnaire
Tijdsspanne: Baseline, 13 weeks, 26 weeks

A subjective measure of memory failure in everyday life
Baseline, 13 weeks, 26 weeks
Muscle strength of quads
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Muscle strength measure by isokinetic dynamometer
Baseline, 13 weeks, 26 weeks
Peripheral QCT of the tibia
Tijdsspanne: Baseline, 13 weeks, 26 weeks

A measure of bone and muscle health
Baseline, 13 weeks, 26 weeks
Blood pressure
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Blood pressure - systolic and diastolic
Baseline, 13 weeks, 26 weeks
Lipid panel
Tijdsspanne: Baseline, 26 weeks

Lipid levels
Baseline, 26 weeks
Hemoglobin A1-C
Tijdsspanne: Baseline, 26 weeks

Average blood sugar levels
Baseline, 26 weeks
C-reactive protein
Tijdsspanne: Baseline, 26 weeks

Measure of inflammation
Baseline, 26 weeks
Health resource utilization
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Cost of health resource used
Baseline, 13 weeks, 26 weeks
Carotid-femoral pulse wave velocity
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Arterial stiffness
Baseline, 13 weeks, 26 weeks
Pittsburgh Sleep Quality Index
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Subjective sleep quality
Baseline, 13 weeks, 26 weeks
Actigraph
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Using actigraphy data, quantify sleep quality (e.g., duration, efficiency, fragmentation).
Baseline, 13 weeks, 26 weeks
Actigraph
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Using actigraphy data, quantify physical activity (e.g., intensity and minutes)
Baseline, 13 weeks, 26 weeks
Actigraph
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Using actigraphy data, quantify sedentary behaviour (minutes)
Baseline, 13 weeks, 26 weeks
Fatigue Severity Scale
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Subjective fatigue
Baseline, 13 weeks, 26 weeks
PHQ-9
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Depression severity
Baseline, 13 weeks, 26 weeks
GAD-7
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Generalized anxiety disorder
Baseline, 13 weeks, 26 weeks
Menopause Rating Scale
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Menopause symptoms
Baseline, 13 weeks, 26 weeks
EuroQol-5 Domain-5 Level
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Quality of life
Baseline, 13 weeks, 26 weeks
International Physical Activity Questionnaire
Tijdsspanne: Every 30 days over 26 weeks

Physical activity
Every 30 days over 26 weeks
DEXA
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Lean mass
Baseline, 13 weeks, 26 weeks
DEXA
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Body fat
Baseline, 13 weeks, 26 weeks
DEXA
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Appendicular Skeletal Muscle Mass Index (ASMI); a measure of sarcopenia
Baseline, 13 weeks, 26 weeks
Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) Diet score
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Diet
Baseline, 13 weeks, 26 weeks
Processing Speed by smartphone
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Processing Speed
Baseline, 13 weeks, 26 weeks
Memory by smartphone
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Memory
Baseline, 13 weeks, 26 weeks
Productivity Questionnaire
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Measure of work productivity
Baseline, 13 weeks, 26 weeks
Brain-Derived Neurotrophic Factor
Tijdsspanne: Baseline, 26 weeks

Neurotrophic Factor
Baseline, 26 weeks
IGF-1
Tijdsspanne: Baseline, 26 weeks

Neurotrophic Factor
Baseline, 26 weeks
Optional Qualitative Interviews
Tijdsspanne: Baseline, 26 weeks

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
Baseline, 26 weeks
Optional Measure: Muscle Health
Tijdsspanne: Baseline, 26 weeks

Myosteatosis measured by Upright Open Magnetic Resonance Imaging (UO-MRI) of the mid-thigh and lower leg (dominant)
Baseline, 26 weeks
Optional Measure: Cerebral Oxygenation
Tijdsspanne: Baseline, 13 weeks, 26 weeks

Measured by the functional near-infrared spectroscopy (fNIRS)
Baseline, 13 weeks, 26 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of British Columbia

Medewerkers

Vancouver Coastal Health Research Institute

Onderzoekers

  • Hoofdonderzoeker: Teresa Liu-Ambrose, PhD, University of British Columbia

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 maart 2026

Primaire voltooiing (Geschat)

15 december 2026

Studie voltooiing (Geschat)

30 januari 2027

Studieregistratiedata

Eerst ingediend

19 november 2025

Eerst ingediend dat voldeed aan de QC-criteria

26 november 2025

Eerst geplaatst (Werkelijk)

9 december 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

16 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • H25-01552

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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