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Bewegung in der Perimenopause zur Verbesserung der kognitiven Gesundheit (EPIC)

16. Oktober 2026 aktualisiert von: Teresa Liu-Ambrose, University of British Columbia

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

  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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V5Z 1M9
        • Rekrutierung
        • University of British Columbia
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre bis 55 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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
Aktiver Komparator: Balance, Flexibility, and Tone Exercises (BAT)

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Rey Auditory Verbal Learning Test (RAVLT)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
NIH TB Cognitive Battery - Flanker Test
Zeitfenster: Baseline, 13 weeks, 26 weeks

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of British Columbia

Mitarbeiter

Vancouver Coastal Health Research Institute

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. März 2026

Primärer Abschluss (Geschätzt)

15. Dezember 2026

Studienabschluss (Geschätzt)

30. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

19. November 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. November 2025

Zuerst gepostet (Tatsächlich)

9. Dezember 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H25-01552

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