Clinical trial NCT04962061: A Combined Multidomain Intervention to Prevent Cognitive Decline Associated With Cardiovascular Risk Factors.
Official title: Impacts of Aerobic, Resistance and Cognitive Training Interventions on Neurocognitive Functions in Older Adults With Cardiovascular Risk Factors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Cardiovascular Risk Factor
Keywords: Aging
Cardiovascular Risk factor
Cognition
Combined Intervention
Cognitive Training
Physical Exercise
Brain Functions
Biomarkers
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: The Montreal Health Innovations Coordinating Center (MHICC)
First posted: 2021-07-14
Enrollment: 159
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The ACTIONcardioRisk trial is designed to investigate the effect of aerobic and progressive resistance training exercises combined with cognitive training, on neurocognitive functioning of sedentary older adults with and without cardiovascular risk factors.

Detailed description: The proportion of older adults is on the rise in Canada, with the fastest growth recorded among those seventy years of age or older. The prevalence of cardiovascular risk factors (CVRF) such as diabetes, hypertension, and high cholesterol increases drastically with age. Individuals with CVRF often show impaired cognition, such as attention and memory deficits. In healthy older adults, exercise training and cognitive stimulation can help enhance cognitive performances. More precisely, combined intervention, including physical and cognitive training, has shown beneficial effects on cognition in older adults without cognitive impairment and with mild cognitive impairment. However, the effect of such programs on cognition in individuals with CVRF is not well documented. This project compares the effect of a physical exercise program, including aerobic and resistance training, alone or combined with cognitive training on cognitive performances and brain imaging outcomes in individuals with CVRF and healthy controls.

Eligibility criteria: Inclusion Criteria:

* Adult aged 60 and older,
* Normal or corrected vision and normal hearing for their age range,
* No cognitive impairment (Mini-Mental State Examination - MMSE ≥ 25),
* Inactive (\< 150 min of physical activity per week).

Exclusion Criteria:

* MMSE ≤ 24 or diagnosis of dementia,
* Uncontrolled psychological / psychiatric condition within the past 6 months,
* Neurological disease,
* Severe exercise intolerance,
* Respiratory disease (e.g., asthma, COPD),
* Excessive alcohol consumption (\> 15 drinks/week),
* Documented cerebral, peripheral or coronary atherosclerotic disease,
* Chronic systolic or diastolic heart failure,
* Symptomatic aortic stenosis,
* Atrial fibrillation,
* Automatic implantable defibrillator or permanent pacemaker,
* Malignant exertional arrhythmias,
* Non-cardiopulmonary limitation to exercise (e.g., arthritis).

Primary outcomes:
measure: Change in general cognitive functioning
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in processing speed
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in executive functions
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in episodic memory
timeFrame: Baseline and post-intervention at 12 months.
Secondary outcomes:
measure: Change in cerebral autoregulation - frontal cortical region
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in cerebral autoregulation - middle cerebral arteries
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in cerebral vasoreactivity - whole brain
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in cerebral vasoreactivity - prefrontal cortex
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in cerebral vasoreactivity - middle cerebral arteries
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in cerebral pulsatility - cortical frontal region
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in cerebral pulsatility - middle cerebral arteries
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in cerebral activity
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in brain structure
timeFrame: Baseline and post-intervention at 12 months.
Other outcomes:
measure: Change in cardiorespiratory fitness
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in peripheral endothelial function
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in central artery stiffness
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in walking speed
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in functional mobility
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in Balance performance
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in lower limb muscles strength
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in upper limb muscle strength
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in total cholesterol
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in cholesterol-HDL
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in cholesterol-LDL calculated
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in cholesterol non-HDL
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in triglycerides
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in glucose
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in glycated hemoglobin (HbA1c)
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in insulin
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in creatinine
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in sodium
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in chloride
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in potassium
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in high-sensitive C-reactive protein (hsCRP)
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in apolipoprotein B (ApoB)
timeFrame: Baseline and post-intervention at 12 months.
measure: Change of neurotrophic biomarkers
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in transcriptomics
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in gut microbiome
timeFrame: Baseline and post-intervention at 12 months
measure: Change in chronic stress levels
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in perceived stress
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in anxiety
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in depressive symptoms
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in health related quality-of-life
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in sleep quality
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in Dietary patterns
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in social and community activities involvement
timeFrame: Baseline and post-intervention at 12 months.
measure: Change in self-reported physical activity
timeFrame: Baseline
measure: Self-reported masculinity and femininity trait
timeFrame: Baseline
measure: Genetic biomarkers
timeFrame: Baseline
measure: Cognitive Reserve
timeFrame: Baseline
measure: Baseline level of physical activity
timeFrame: Baseline
Locations:
city: Montreal
country: Canada
facility: Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Louis Bherer, PhD
role: PRINCIPAL_INVESTIGATOR
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