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Exercice pendant la périménopause pour améliorer la santé cognitive (EPIC)

16 octobre 2026 mis à jour par: Teresa Liu-Ambrose, University of British Columbia

Entraînement en résistance et santé cognitive pendant la périménopause

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

  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.

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans à 55 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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.

Autres noms:
  • PRT
Comparateur actif: Balance, Flexibility, and Tone Exercises (BAT)

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

Autres noms:
  • CHAUVE SOURIS

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Rey Auditory Verbal Learning Test (RAVLT)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
NIH TB Cognitive Battery - Flanker Test
Délai: Baseline, 13 weeks, 26 weeks

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of British Columbia

Collaborateurs

Vancouver Coastal Health Research Institute

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 mars 2026

Achèvement primaire (Estimé)

15 décembre 2026

Achèvement de l'étude (Estimé)

30 janvier 2027

Dates d'inscription aux études

Première soumission

19 novembre 2025

Première soumission répondant aux critères de contrôle qualité

26 novembre 2025

Première publication (Réel)

9 décembre 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • H25-01552

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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