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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| The Montreal Health Innovations Coordinating Center (MHICC) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidomain intervention | Experimental | 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. |
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| Physical exercise intervention | Experimental | 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. |
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| Active control intervention | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Training | Other | Participants will be encouraged to perform sessions of cognitive training 3 times per week (30 minutes/session). Two of these sessions will involve computer- or tablet-based attentional control training targeting dual-tasking, updating and working memory, as well as inhibition and switching. Difficulty of cognitive training will be tailored to participants' performances. The remaining session will consist of memory training. Participants will be instructed mnemotechnic, as well as be taught about memory in aging in general. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in general cognitive functioning | Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning). | Baseline and post-intervention at 12 months. |
| Change in processing speed | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). | Baseline and post-intervention at 12 months. |
| Change in executive functions | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). | Baseline and post-intervention at 12 months. |
| Change in episodic memory | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). | Baseline and post-intervention at 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cerebral autoregulation - frontal cortical region | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiorespiratory fitness | Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)). | Baseline and post-intervention at 12 months. |
| Change in peripheral endothelial function | Fow-mediated dilation of the brachial artery (%). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louis Bherer, PhD | Contact | 514-374-1480 | 4355 | louis.bherer@umontreal.ca |
| Anil Nigam, MD | Contact | 514-376-3330 | 4033 | anil.nigam@icm-mhi.org |
| Name | Affiliation | Role |
|---|---|---|
| Louis Bherer, PhD | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute | Recruiting | Montreal | Quebec | H1T1N6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21143340 | Background | Arntzen KA, Schirmer H, Wilsgaard T, Mathiesen EB. Impact of cardiovascular risk factors on cognitive function: the Tromso study. Eur J Neurol. 2011 May;18(5):737-43. doi: 10.1111/j.1468-1331.2010.03263.x. Epub 2010 Dec 8. | |
| 20847403 | Background | Baker LD, Frank LL, Foster-Schubert K, Green PS, Wilkinson CW, McTiernan A, Cholerton BA, Plymate SR, Fishel MA, Watson GS, Duncan GE, Mehta PD, Craft S. Aerobic exercise improves cognition for older adults with glucose intolerance, a risk factor for Alzheimer's disease. J Alzheimers Dis. 2010;22(2):569-79. doi: 10.3233/JAD-2010-100768. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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This clinical trial is a double-blinded study. Research personnel performing the outcome assessments will be blinded to group allocation. Participants will be aware of the type of training they receive, but they will be blinded to the "active" intervention and study hypotheses.
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| Aerobic and resistance exercises | Other | Participants will follow a periodized exercise training program with thrice-weekly 60 minutes trainings. The sessions will start with a 5-10mins warm-up, followed by aerobic and resistance trainings, and ends with a 5-10mins cool-down and stretching period. Intensity of aerobic sessions will be monitored with heart rate chest strap and should match with the moderate to vigorous intensity zone as defined by the ACSM (65% of Heart Rate maximum or more and a Perceived Exertion higher than 12 on the 6 to 20 Borg scale). Exercise intensity and duration will be gradually increased during the program. After aerobic training, a 15-20mins resistance training will be performed with a gradual progression of higher intensities and/or numbers of sets. The one maximal repetition (1RM) will be assessed for each RT movements at baseline, during (each 3 months) and at the end of the program. RT intensities will go from 40 to 70% of 1RM, with 8 to 10 forms of exercise involving majors muscle groups. |
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| Stretching and Toning | Other | Participants in the active control condition will take part in three 60 minutes stretching and toning sessions per week. Each session will start with a five-minutes warm-up, followed by fifteen min of body stretching exercises mainly in a seated position and finish with a five-minutes cool down. Participants will engage in four muscle-toning exercises (light intensity) using dumbbells or resistance bands, two exercises designed to improve balance, one yoga sequence, and one exercise of their choice. Intensity of stretching and toning sessions will be monitored with heart rate chest strap and should not exceed the light intensity zone as defined by the ACSM (64% of Heart Rate maximum or less and a Perceived Exertion lower than 11 on the 6 to 20 Borg scale). |
|
| Baseline and post-intervention at 12 months. |
| Change in cerebral autoregulation - middle cerebral arteries | 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. | Baseline and post-intervention at 12 months. |
| Change in cerebral vasoreactivity - whole brain | 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. | Baseline and post-intervention at 12 months. |
| Change in cerebral vasoreactivity - prefrontal cortex | Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using NIRS in the prefrontal region. | Baseline and post-intervention at 12 months. |
| Change in cerebral vasoreactivity - middle cerebral arteries | Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using TCD in the middle cerebral arteries | Baseline and post-intervention at 12 months. |
| Change in cerebral pulsatility - cortical frontal region | 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. | Baseline and post-intervention at 12 months. |
| Change in cerebral pulsatility - middle cerebral arteries | Pulsatility will be measured as the normalized difference of relative blood flow velocities between systole and diastole, using TCD in the middle cerebral arteries. | Baseline and post-intervention at 12 months. |
| Change in cerebral activity | 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. | Baseline and post-intervention at 12 months. |
| Change in brain structure | 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. | Baseline and post-intervention at 12 months. |
| Baseline and post-intervention at 12 months. |
| Change in central artery stiffness | Carotid femoral pulse-wave velocity (m/s). | Baseline and post-intervention at 12 months. |
| Change in walking speed | Timed 10-meter walking test (cm/s). | Baseline and post-intervention at 12 months. |
| Change in functional mobility | Timed Time up and Go test (s). | Baseline and post-intervention at 12 months. |
| Change in Balance performance | Timed one-leg standing test (s). | Baseline and post-intervention at 12 months. |
| Change in lower limb muscles strength | Timed Sit-to-Stand test (s) | Baseline and post-intervention at 12 months. |
| Change in upper limb muscle strength | Grip strength test score (kg). | Baseline and post-intervention at 12 months. |
| Change in total cholesterol | Total cholesterol levels (mmol/L) | Baseline and post-intervention at 12 months. |
| Change in cholesterol-HDL | Cholesterol-HDL levels (mmol/L) | Baseline and post-intervention at 12 months. |
| Change in cholesterol-LDL calculated | Cholesterol-LDL calculated levels (mmol/L) | Baseline and post-intervention at 12 months. |
| Change in cholesterol non-HDL | Cholesterol non-HDL levels (mmol/L) | Baseline and post-intervention at 12 months. |
| Change in triglycerides | Triglycerides levels (mmol/L) | Baseline and post-intervention at 12 months. |
| Change in glucose | Glucose levels (mmol/L) | Baseline and post-intervention at 12 months. |
| Change in glycated hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c) (%) | Baseline and post-intervention at 12 months. |
| Change in insulin | Insulin levels (pmol/L) | Baseline and post-intervention at 12 months. |
| Change in creatinine | Creatinine levels (mg/dL) | Baseline and post-intervention at 12 months. |
| Change in sodium | Sodium levels (mmol/L) | Baseline and post-intervention at 12 months. |
| Change in chloride | Chloride levels (mmol/L) | Baseline and post-intervention at 12 months. |
| Change in potassium | Potassium levels (mmol/L) | Baseline and post-intervention at 12 months. |
| Change in high-sensitive C-reactive protein (hsCRP) | High-sensitive C-reactive protein (hsCRP) levels (mg/L) | Baseline and post-intervention at 12 months. |
| Change in apolipoprotein B (ApoB) | Apolipoprotein B (ApoB) levels (g/L) | Baseline and post-intervention at 12 months. |
| Change of neurotrophic biomarkers | Brain-derived neurotrophic factor (BDNF) plasma concentration (pg/mL). | Baseline and post-intervention at 12 months. |
| Change in transcriptomics | Transcriptome analysis to assess the impact of the intervention on any changes in the activity of different cellular processes. | Baseline and post-intervention at 12 months. |
| Change in gut microbiome | DNA extraction from fecal samples. The fecal samples will be collected from the participants who are also performing MRI. | Baseline and post-intervention at 12 months |
| Change in chronic stress levels | Cortisol levels from saliva samples (nmol/L). The saliva samples will be collected from the participants who are also performing MRI. | Baseline and post-intervention at 12 months. |
| Change in perceived stress | Perceived Stress Scale questionnaire (Score ranges from 0-4, with 0 no stress,1 mild stress, 3 moderate stress and 4 severe). | Baseline and post-intervention at 12 months. |
| Change in anxiety | State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety). | Baseline and post-intervention at 12 months. |
| Change in depressive symptoms | Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology). | Baseline and post-intervention at 12 months. |
| Change in health related quality-of-life | 12-Item Short Form Health Survey (a completer). | Baseline and post-intervention at 12 months. |
| Change in sleep quality | Pittsburg Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality). | Baseline and post-intervention at 12 months. |
| Change in Dietary patterns | Short Diet Questionnaire (Score ranges from 15-45 points, with a score between 15-29 categorised as unhealthy, 30-37 as somewhat unhealthy, and 38 or more as a healthy diet). | Baseline and post-intervention at 12 months. |
| Change in social and community activities involvement | Social and community involvement questionnaire (Score ranges from 0-200, with a higher score indicating more social and community involvement). | Baseline and post-intervention at 12 months. |
| Change in self-reported physical activity | Physical Activity Scale for the Elderly questionnaire (Score ranges from 0-400, with a higher score indicating better level of physical activity). | Baseline |
| Self-reported masculinity and femininity trait | Short Form Bem Sex-Role Inventory questionnaire (30 items questionnaire with 10 items assessing the femininity traits, 10 items assessing the masculinity traits, and 10 items neutral, not scored. Two scores are calculated for femininity and masculinity, respectively, and range from 10-70, whit a higher score indicating a higher femininity or masculinity trait). | Baseline |
| Genetic biomarkers | Genotyping array to generate high quality genome-wide genotyping data that include the APOE and BDNF genes. | Baseline |
| Cognitive Reserve | Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve). | Baseline |
| Baseline level of physical activity | Quantification of physical activity using an accelerometry recording of 7 days (minutes of moderate to vigorous activity). | Baseline |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |