Exercise in Perimenopause to Improve Cognitive Health

N/ANot Yet RecruitingNCT07272174

University of British Columbia50 enrolled

Overview

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.

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. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Interventions

Progressive Resistance TrainingBEHAVIORAL

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.

Balance, Flexibility, and Tone ExercisesBEHAVIORAL

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).

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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, 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 * Had premature ovarian failure; or * Are already enrolled in a drug or exercise trial

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 13 weeks, 26 weeks

Secondary Outcomes

NIH TB Cognitive Battery - Flanker Test

A measure of executive functions

Time frame: Baseline, 13 weeks, 26 weeks

NIH TB Cognitive Battery - Dimensional Change Card Sort Test

A measure of executive functions

Time frame: Baseline, 13 weeks, 26 weeks

NIH TB Cognitive Battery - Picture Sequence Memory Test

A measure of visual episodic memory

Time frame: Baseline, 13 weeks, 26 weeks

NIH TB Cognitive Battery - List Sorting Test

A measure of working memory

Time frame: Baseline, 13 weeks, 26 weeks

NIH TB Cognitive Battery - Pattern Comparison Processing Speed Test

A measure of processing speed

Time frame: Baseline, 13 weeks, 26 weeks

Everyday Memory Questionnaire

A subjective measure of memory failure in everyday life

Time frame: Baseline, 13 weeks, 26 weeks

Muscle strength of quads

Muscle strength measure by isokinetic dynamometer

Time frame: Baseline, 13 weeks, 26 weeks

Peripheral QCT of the tibia

A measure of bone and muscle health

Time frame: Baseline, 13 weeks, 26 weeks

Blood pressure

Blood pressure - systolic and diastolic

Time frame: Baseline, 13 weeks, 26 weeks

Lipid panel

Lipid levels

Time frame: Baseline, 26 weeks

Hemoglobin A1-C

Average blood sugar levels

Time frame: Baseline, 26 weeks

C-reactive protein

Measure of inflammation

Time frame: Baseline, 26 weeks

Health resource utilization

Cost of health resource used

Time frame: Baseline, 13 weeks, 26 weeks

Carotid-femoral pulse wave velocity

Arterial stiffness

Time frame: Baseline, 13 weeks, 26 weeks

Pittsburgh Sleep Quality Index

Subjective sleep quality

Time frame: Baseline, 13 weeks, 26 weeks

Sensewear Band

Using actigraphy data, quantify sleep quality (e.g., duration, efficiency, fragmentation).

Time frame: Baseline, 13 weeks, 26 weeks

Sensewear Band

Using actigraphy data, quantify physical activity (e.g., intensity and minutes)

Time frame: Baseline, 13 weeks, 26 weeks

Sensewear Band

Using actigraphy data, quantify sedentary behaviour (minutes)

Time frame: Baseline, 13 weeks, 26 weeks

Fatigue Severity Scale

Subjective fatigue

Time frame: Baseline, 13 weeks, 26 weeks

PHQ-9

Depression severity

Time frame: Baseline, 13 weeks, 26 weeks

GAD-7

Generalized anxiety disorder

Time frame: Baseline, 13 weeks, 26 weeks

Menopause Rating Scale

Menopause symptoms

Time frame: Baseline, 13 weeks, 26 weeks

EuroQol-5 Domain-5 Level

Quality of life

Time frame: Baseline, 13 weeks, 26 weeks

International Physical Activity Questionnaire

Physical activity

Time frame: Every 30 days over 26 weeks

DEXA

Lean mass

Time frame: Baseline, 13 weeks, 26 weeks

DEXA

Body fat

Time frame: Baseline, 13 weeks, 26 weeks

DEXA

Appendicular Skeletal Muscle Mass Index (ASMI); a measure of sarcopenia

Time frame: Baseline, 13 weeks, 26 weeks

Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) Diet score

Diet

Time frame: Baseline, 13 weeks, 26 weeks

Processing Speed by smartphone

Processing Speed

Time frame: Baseline, 13 weeks, 26 weeks

Memory by smartphone

Memory

Time frame: Baseline, 13 weeks, 26 weeks

Productivity Questionnaire

Measure of work productivity

Time frame: Baseline, 13 weeks, 26 weeks

Brain-Derived Neurotrophic Factor

Neurotrophic Factor

Time frame: Baseline, 26 weeks

IGF-1

Neurotrophic Factor

Time frame: Baseline, 26 weeks

Central Contacts

Teresa Liu-Ambrose, PhD

CONTACT

6046178047 teresa.ambrose@ubc.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Exercise in Perimenopause to Improve Cognitive Health

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts