A Combined Multidomain Intervention to Prevent Cognitive Decline Associated with Cardiovascular Risk Factors.
- Conditions
- AgingCardiovascular Risk Factor
- Interventions
- Other: Cognitive TrainingOther: Aerobic and resistance exercisesOther: Stretching and Toning
- Registration Number
- NCT04962061
- Lead Sponsor
- Louis Bherer
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 159
- 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).
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multidomain intervention Cognitive Training The multidomain intervention will combine a cognitive training with aerobic and resistance exercises training, three sessions per week for 46 weeks. Participants will be allowed to perform cognitive and exercise training sessions either home-based or centre-based. Physical exercise intervention Aerobic and resistance exercises The physical exercises intervention will include aerobic and resistance exercises training, three sessions per week for 46 weeks. Participants will be allowed to perform cognitive and exercise training sessions either home-based or centre-based. Multidomain intervention Aerobic and resistance exercises The multidomain intervention will combine a cognitive training with aerobic and resistance exercises training, three sessions per week for 46 weeks. Participants will be allowed to perform cognitive and exercise training sessions either home-based or centre-based. Active control intervention Stretching and Toning The active control intervention will include stretching and toning exercises, three sessions per week for 46 weeks. Participants will be allowed to perform cognitive and exercise training sessions either home-based or centre-based.
- Primary Outcome Measures
Name Time Method Change in processing speed Baseline and post-intervention at 12 months. Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in executive functions Baseline and post-intervention at 12 months. Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Change in general cognitive functioning Baseline and post-intervention at 12 months. Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).
Change in episodic memory Baseline and post-intervention at 12 months. Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
- Secondary Outcome Measures
Name Time Method Change in cerebral vasoreactivity - whole brain Baseline and post-intervention at 12 months. Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured by Arterial Spin Labeling MRI in two third of the study participants who do not present contra-indication for imaging studies.
Change in cerebral autoregulation - frontal cortical region Baseline and post-intervention at 12 months. Variations of prefrontal cortical oxygen saturation (rSO2, \[HbO\]/(\[HbO\]+\[HbR\])) will be measured by Near Infrared Spectroscopy (NIRS), as a surrogate of cortical blood flow. Variations of continuous peripheral blood pressure (mm Hg) will be simultaneously measured by plethysmography at the finger. Autoregulation indices (unitless) will be derived from the correlation between variations of oxygen saturation measures and variations of peripheral blood pressure.
Change in cerebral autoregulation - middle cerebral arteries Baseline and post-intervention at 12 months. Variations of cerebral blood flow velocity (cm/s) at the level of the middle cerebral artery will be measured by Transcranial Doppler (TCD). Variations of continuous peripheral blood pressure (mm Hg) will be simultaneously measured by plethysmography at the finger. Autoregulation indices (unitless) will be derived from the correlation between variations of cerebral blood flow measures and variations of peripheral blood pressure.
Change in cerebral vasoreactivity - prefrontal cortex Baseline and post-intervention at 12 months. Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using NIRS in the prefrontal region.
Change in cerebral vasoreactivity - middle cerebral arteries Baseline and post-intervention at 12 months. Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using TCD in the middle cerebral arteries
Change in cerebral pulsatility - cortical frontal region Baseline and post-intervention at 12 months. Pulsatility will be measured as the normalized difference of relative near-infrared light intensity changes between systole and diastole, using NIRS in the prefrontal cortical region.
Change in cerebral pulsatility - middle cerebral arteries Baseline and post-intervention at 12 months. Pulsatility will be measured as the normalized difference of relative blood flow velocities between systole and diastole, using TCD in the middle cerebral arteries.
Change in cerebral activity Baseline and post-intervention at 12 months. Significant changes in brain activity evoked by a Stroop task relative to baseline will be assessed by t-statistics maps, computed from variations of \[HbO\] and \[HbR\] measured by NIRS at the prefrontal cortex.
Change in brain structure Baseline and post-intervention at 12 months. Multimodal structural MRI will be performed in two third of the study participants who do not present contra-indication for imaging studies, to measure regional cerebral volumes, as well as volume of angiopathic markers (eg lacunes, microbleeds, white matter hyperintensities), in cm3.
Trial Locations
- Locations (1)
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada