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| Name | Class |
|---|---|
| Vancouver Coastal Health Research Institute | OTHER |
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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.
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.
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.
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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progressive Resistance Training (PRT) | Experimental | 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. |
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| Balance, Flexibility, and Tone Exercises (BAT) | Active Comparator | Each BAT session will be 1-hr in duration. 2x/week and group-based. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive Resistance Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rey Auditory Verbal Learning Test (RAVLT) | The RAVLT is a valid, reliable, and widely-used instrument of verbal episodic memory and learning, with normative values. | Baseline, 13 weeks, 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| NIH TB Cognitive Battery - Flanker Test | A measure of executive functions | Baseline, 13 weeks, 26 weeks |
| NIH TB Cognitive Battery - Dimensional Change Card Sort Test | A measure of executive functions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresa Liu-Ambrose, PhD | Contact | 6046178047 | teresa.ambrose@ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Teresa Liu-Ambrose, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| ID | Term |
|---|---|
| D018583 | Pliability |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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| Balance, Flexibility, and Tone Exercises | Behavioral | 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). |
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| Baseline, 13 weeks, 26 weeks |
| NIH TB Cognitive Battery - Picture Sequence Memory Test | A measure of visual episodic memory | Baseline, 13 weeks, 26 weeks |
| NIH TB Cognitive Battery - List Sorting Test | A measure of working memory | Baseline, 13 weeks, 26 weeks |
| NIH TB Cognitive Battery - Pattern Comparison Processing Speed Test | A measure of processing speed | Baseline, 13 weeks, 26 weeks |
| Everyday Memory Questionnaire | A subjective measure of memory failure in everyday life | Baseline, 13 weeks, 26 weeks |
| Muscle strength of quads | Muscle strength measure by isokinetic dynamometer | Baseline, 13 weeks, 26 weeks |
| Peripheral QCT of the tibia | A measure of bone and muscle health | Baseline, 13 weeks, 26 weeks |
| Blood pressure | Blood pressure - systolic and diastolic | Baseline, 13 weeks, 26 weeks |
| Lipid panel | Lipid levels | Baseline, 26 weeks |
| Hemoglobin A1-C | Average blood sugar levels | Baseline, 26 weeks |
| C-reactive protein | Measure of inflammation | Baseline, 26 weeks |
| Health resource utilization | Cost of health resource used | Baseline, 13 weeks, 26 weeks |
| Carotid-femoral pulse wave velocity | Arterial stiffness | Baseline, 13 weeks, 26 weeks |
| Pittsburgh Sleep Quality Index | Subjective sleep quality | Baseline, 13 weeks, 26 weeks |
| Actigraph | Using actigraphy data, quantify sleep quality (e.g., duration, efficiency, fragmentation). | Baseline, 13 weeks, 26 weeks |
| Actigraph | Using actigraphy data, quantify physical activity (e.g., intensity and minutes) | Baseline, 13 weeks, 26 weeks |
| Actigraph | Using actigraphy data, quantify sedentary behaviour (minutes) | Baseline, 13 weeks, 26 weeks |
| Fatigue Severity Scale | Subjective fatigue | Baseline, 13 weeks, 26 weeks |
| PHQ-9 | Depression severity | Baseline, 13 weeks, 26 weeks |
| GAD-7 | Generalized anxiety disorder | Baseline, 13 weeks, 26 weeks |
| Menopause Rating Scale | Menopause symptoms | Baseline, 13 weeks, 26 weeks |
| EuroQol-5 Domain-5 Level | Quality of life | Baseline, 13 weeks, 26 weeks |
| International Physical Activity Questionnaire | Physical activity | Every 30 days over 26 weeks |
| DEXA | Lean mass | Baseline, 13 weeks, 26 weeks |
| DEXA | Body fat | Baseline, 13 weeks, 26 weeks |
| DEXA | 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 | Diet | Baseline, 13 weeks, 26 weeks |
| Processing Speed by smartphone | Processing Speed | Baseline, 13 weeks, 26 weeks |
| Memory by smartphone | Memory | Baseline, 13 weeks, 26 weeks |
| Productivity Questionnaire | Measure of work productivity | Baseline, 13 weeks, 26 weeks |
| Brain-Derived Neurotrophic Factor | Neurotrophic Factor | Baseline, 26 weeks |
| IGF-1 | Neurotrophic Factor | Baseline, 26 weeks |