Exercise in Perimenopause to Improve Cognitive Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-55
SponsorUniversity of British Columbia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Progressive Resistance Training
BehavioralThe 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 Exercises
BehavioralEach 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).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Progressive Resistance Training (PRT)Experimental treatment 1 intervention
Group B: Balance, Flexibility, and Tone Exercises (BAT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
NIH TB Cognitive Battery - Flanker Test
A measure of executive functions
Time frame
Baseline, 13 weeks, 26 weeks2
NIH TB Cognitive Battery - Dimensional Change Card Sort Test
A measure of executive functions
Time frame
Baseline, 13 weeks, 26 weeks3
NIH TB Cognitive Battery - Picture Sequence Memory Test
A measure of visual episodic memory
Time frame
Baseline, 13 weeks, 26 weeks4
NIH TB Cognitive Battery - List Sorting Test
A measure of working memory
Time frame
Baseline, 13 weeks, 26 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
Vancouver Coastal Health Research Institute
Collaborator
Source ClinicalTrials.gov