Exercise in Perimenopause to Improve Cognitive Health (EPIC)

University of British Columbia

Status: Begins enrollment this month

Conditions: Subjective Cognitive Complaints; Perimenopause

Treatments: Behavioral: Balance, Flexibility, and Tone Exercises; Behavioral: Progressive Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07272174

H25-01552

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Progressive Resistance Training (PRT)

Experimental group

Description:

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.

Treatment:

Behavioral: Progressive Resistance Training

Balance, Flexibility, and Tone Exercises (BAT)

Active Comparator group

Description:

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

Treatment:

Behavioral: Balance, Flexibility, and Tone Exercises