Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Trening i perimenopause for å forbedre kognitiv helse (EPIC)

16. oktober 2026 oppdatert av: Teresa Liu-Ambrose, University of British Columbia

Motstandstrening og kognitiv helse i 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

  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

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Rekruttering
        • University of British Columbia
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 55 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.

Andre navn:
  • PRT
Aktiv komparator: Balance, Flexibility, and Tone Exercises (BAT)

Each BAT session will be 1-hr in duration. 2x/week and group-based.
Atferdsmessig: 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).

Andre navn:
  • FLAGGERMUS

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rey Auditory Verbal Learning Test (RAVLT)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
NIH TB Cognitive Battery - Flanker Test
Tidsramme: Baseline, 13 weeks, 26 weeks

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Neurotrophic Factor
Baseline, 26 weeks
Optional Qualitative Interviews
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, 13 weeks, 26 weeks

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of British Columbia

Samarbeidspartnere

Vancouver Coastal Health Research Institute

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. mars 2026

Primær fullføring (Antatt)

15. desember 2026

Studiet fullført (Antatt)

30. januar 2027

Datoer for studieregistrering

Først innsendt

19. november 2025

Først innsendt som oppfylte QC-kriteriene

26. november 2025

Først lagt ut (Faktiske)

9. desember 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H25-01552

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere