Ejercicio en la Perimenopausia para Mejorar la Salud Cognitiva (EPIC)
Entrenamiento de Resistencia y Salud Cognitiva en la Perimenopausia
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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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.
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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.
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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.
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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).
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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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Teresa Liu-Ambrose, PhD
- Número de teléfono: 6046178047
- Correo electrónico: teresa.ambrose@ubc.ca
Ubicaciones de estudio
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Reclutamiento
- University of British Columbia
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Contacto:
- Teresa Liu-Ambrose, MHK
- Número de teléfono: 69059 604-875-4111
- Correo electrónico: teresa.ambrose@ubc.ca
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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. |
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.
Otros nombres:
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Comparador activo: 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).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rey Auditory Verbal Learning Test (RAVLT)
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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The RAVLT is a valid, reliable, and widely-used instrument of verbal episodic memory and learning, with normative values. |
Baseline, 13 weeks, 26 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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NIH TB Cognitive Battery - Flanker Test
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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A measure of executive functions |
Baseline, 13 weeks, 26 weeks
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NIH TB Cognitive Battery - Dimensional Change Card Sort Test
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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A measure of executive functions |
Baseline, 13 weeks, 26 weeks
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NIH TB Cognitive Battery - Picture Sequence Memory Test
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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A measure of visual episodic memory |
Baseline, 13 weeks, 26 weeks
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NIH TB Cognitive Battery - List Sorting Test
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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A measure of working memory |
Baseline, 13 weeks, 26 weeks
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NIH TB Cognitive Battery - Pattern Comparison Processing Speed Test
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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A measure of processing speed |
Baseline, 13 weeks, 26 weeks
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Everyday Memory Questionnaire
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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A subjective measure of memory failure in everyday life |
Baseline, 13 weeks, 26 weeks
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Muscle strength of quads
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Muscle strength measure by isokinetic dynamometer |
Baseline, 13 weeks, 26 weeks
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Peripheral QCT of the tibia
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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A measure of bone and muscle health |
Baseline, 13 weeks, 26 weeks
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Blood pressure
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Blood pressure - systolic and diastolic |
Baseline, 13 weeks, 26 weeks
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Lipid panel
Periodo de tiempo: Baseline, 26 weeks
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Lipid levels |
Baseline, 26 weeks
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Hemoglobin A1-C
Periodo de tiempo: Baseline, 26 weeks
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Average blood sugar levels |
Baseline, 26 weeks
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C-reactive protein
Periodo de tiempo: Baseline, 26 weeks
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Measure of inflammation |
Baseline, 26 weeks
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Health resource utilization
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Cost of health resource used |
Baseline, 13 weeks, 26 weeks
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Carotid-femoral pulse wave velocity
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Arterial stiffness |
Baseline, 13 weeks, 26 weeks
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Pittsburgh Sleep Quality Index
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Subjective sleep quality |
Baseline, 13 weeks, 26 weeks
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Actigraph
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Using actigraphy data, quantify sleep quality (e.g., duration, efficiency, fragmentation). |
Baseline, 13 weeks, 26 weeks
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Actigraph
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Using actigraphy data, quantify physical activity (e.g., intensity and minutes) |
Baseline, 13 weeks, 26 weeks
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Actigraph
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Using actigraphy data, quantify sedentary behaviour (minutes) |
Baseline, 13 weeks, 26 weeks
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Fatigue Severity Scale
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Subjective fatigue |
Baseline, 13 weeks, 26 weeks
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PHQ-9
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Depression severity |
Baseline, 13 weeks, 26 weeks
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GAD-7
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Generalized anxiety disorder |
Baseline, 13 weeks, 26 weeks
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Menopause Rating Scale
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Menopause symptoms |
Baseline, 13 weeks, 26 weeks
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EuroQol-5 Domain-5 Level
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Quality of life |
Baseline, 13 weeks, 26 weeks
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International Physical Activity Questionnaire
Periodo de tiempo: Every 30 days over 26 weeks
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Physical activity |
Every 30 days over 26 weeks
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DEXA
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Lean mass |
Baseline, 13 weeks, 26 weeks
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DEXA
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Body fat |
Baseline, 13 weeks, 26 weeks
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DEXA
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Appendicular Skeletal Muscle Mass Index (ASMI); a measure of sarcopenia |
Baseline, 13 weeks, 26 weeks
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Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) Diet score
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Diet |
Baseline, 13 weeks, 26 weeks
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Processing Speed by smartphone
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Processing Speed |
Baseline, 13 weeks, 26 weeks
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Memory by smartphone
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Memory |
Baseline, 13 weeks, 26 weeks
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Productivity Questionnaire
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Measure of work productivity |
Baseline, 13 weeks, 26 weeks
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Brain-Derived Neurotrophic Factor
Periodo de tiempo: Baseline, 26 weeks
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Neurotrophic Factor |
Baseline, 26 weeks
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IGF-1
Periodo de tiempo: Baseline, 26 weeks
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Neurotrophic Factor |
Baseline, 26 weeks
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Optional Qualitative Interviews
Periodo de tiempo: Baseline, 26 weeks
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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
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Optional Measure: Muscle Health
Periodo de tiempo: Baseline, 26 weeks
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Myosteatosis measured by Upright Open Magnetic Resonance Imaging (UO-MRI) of the mid-thigh and lower leg (dominant) |
Baseline, 26 weeks
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Optional Measure: Cerebral Oxygenation
Periodo de tiempo: Baseline, 13 weeks, 26 weeks
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Measured by the functional near-infrared spectroscopy (fNIRS) |
Baseline, 13 weeks, 26 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Teresa Liu-Ambrose, PhD, University of British Columbia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H25-01552
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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