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Motion i perimenopausen for at forbedre kognitiv sundhed (EPIC)

16. oktober 2026 opdateret af: Teresa Liu-Ambrose, University of British Columbia

Modstandstræning og kognitiv sundhed i perimenopausen

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Rekruttering
        • University of British Columbia
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

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

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

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 navne:
  • FLAGERMUS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. marts 2026

Primær færdiggørelse (Anslået)

15. december 2026

Studieafslutning (Anslået)

30. januar 2027

Datoer for studieregistrering

Først indsendt

19. november 2025

Først indsendt, der opfyldte QC-kriterier

26. november 2025

Først opslået (Faktiske)

9. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H25-01552

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