University of British Columbia
Vancouver, British Columbia, V5Z 1M9, Canada
Location status: Recruiting
NCT Number: NCT07272174
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.
Interested in participating?
Request Info40 year–55 year
Female
Interventional
Not applicable
Vancouver, British Columbia, V5Z 1M9, Canada
Location status: Recruiting
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.
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.
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.
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.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: PRT
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).
Other names: BAT
Time frame: Baseline, 13 weeks, 26 weeks
The RAVLT is a valid, reliable, and widely-used instrument of verbal episodic memory and learning, with normative values.
Time frame: Baseline, 13 weeks, 26 weeks
A measure of executive functions
Time frame: Baseline, 13 weeks, 26 weeks
A measure of executive functions
Time frame: Baseline, 13 weeks, 26 weeks
A measure of visual episodic memory
Time frame: Baseline, 13 weeks, 26 weeks
A measure of working memory
Time frame: Baseline, 13 weeks, 26 weeks
A measure of processing speed
Time frame: Baseline, 13 weeks, 26 weeks
A subjective measure of memory failure in everyday life
Time frame: Baseline, 13 weeks, 26 weeks
Muscle strength measure by isokinetic dynamometer
Time frame: Baseline, 13 weeks, 26 weeks
A measure of bone and muscle health
Time frame: Baseline, 13 weeks, 26 weeks
Blood pressure - systolic and diastolic
Time frame: Baseline, 26 weeks
Lipid levels
Time frame: Baseline, 26 weeks
Average blood sugar levels
Time frame: Baseline, 26 weeks
Measure of inflammation
Time frame: Baseline, 13 weeks, 26 weeks
Cost of health resource used
Time frame: Baseline, 13 weeks, 26 weeks
Arterial stiffness
Time frame: Baseline, 13 weeks, 26 weeks
Subjective sleep quality
Time frame: Baseline, 13 weeks, 26 weeks
Using actigraphy data, quantify sleep quality (e.g., duration, efficiency, fragmentation).
Time frame: Baseline, 13 weeks, 26 weeks
Using actigraphy data, quantify physical activity (e.g., intensity and minutes)
Time frame: Baseline, 13 weeks, 26 weeks
Using actigraphy data, quantify sedentary behaviour (minutes)
Time frame: Baseline, 13 weeks, 26 weeks
Subjective fatigue
Time frame: Baseline, 13 weeks, 26 weeks
Depression severity
Time frame: Baseline, 13 weeks, 26 weeks
Generalized anxiety disorder
Time frame: Baseline, 13 weeks, 26 weeks
Menopause symptoms
Time frame: Baseline, 13 weeks, 26 weeks
Quality of life
Time frame: Every 30 days over 26 weeks
Physical activity
Time frame: Baseline, 13 weeks, 26 weeks
Lean mass
Time frame: Baseline, 13 weeks, 26 weeks
Body fat
Time frame: Baseline, 13 weeks, 26 weeks
Appendicular Skeletal Muscle Mass Index (ASMI); a measure of sarcopenia
Time frame: Baseline, 13 weeks, 26 weeks
Diet
Time frame: Baseline, 13 weeks, 26 weeks
Processing Speed
Time frame: Baseline, 13 weeks, 26 weeks
Memory
Time frame: Baseline, 13 weeks, 26 weeks
Measure of work productivity
Time frame: Baseline, 26 weeks
Neurotrophic Factor
Time frame: Baseline, 26 weeks
Neurotrophic Factor
Contact information is provided by the study sponsor or research team.
University of British Columbia
Other
Resistance Training and Cognitive Health in Perimenopause
Acronym: EPIC
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