A Combined Multidomain Intervention to Prevent Cognitive Decline Associated with Cardiovascular Risk Factors. (ACTIONcR)

February 4, 2025 updated by: Louis Bherer

Impacts of Aerobic, Resistance and Cognitive Training Interventions on Neurocognitive Functions in Older Adults with Cardiovascular Risk Factors.

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H1T1N6
        • Recruiting
        • Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
        • Contact:
        • Contact:
          • Louis Bherer, PhD
        • Contact:
          • Anil Nigam, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multidomain intervention
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.
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.
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.
Experimental: Physical exercise intervention
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.
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.
Active Comparator: Active control intervention
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in general cognitive functioning
Time Frame: Baseline and post-intervention at 12 months.
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
Time Frame: Baseline and post-intervention at 12 months.
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Baseline and post-intervention at 12 months.
Change in executive functions
Time Frame: Baseline and post-intervention at 12 months.
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Baseline and post-intervention at 12 months.
Change in episodic memory
Time Frame: Baseline and post-intervention at 12 months.
Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).
Baseline and post-intervention at 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cerebral autoregulation - frontal cortical region
Time Frame: 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.
Baseline and post-intervention at 12 months.
Change in cerebral autoregulation - middle cerebral arteries
Time Frame: 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.
Baseline and post-intervention at 12 months.
Change in cerebral vasoreactivity - whole brain
Time Frame: 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.
Baseline and post-intervention at 12 months.
Change in cerebral vasoreactivity - prefrontal cortex
Time Frame: 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.
Baseline and post-intervention at 12 months.
Change in cerebral vasoreactivity - middle cerebral arteries
Time Frame: 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
Baseline and post-intervention at 12 months.
Change in cerebral pulsatility - cortical frontal region
Time Frame: 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.
Baseline and post-intervention at 12 months.
Change in cerebral pulsatility - middle cerebral arteries
Time Frame: 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.
Baseline and post-intervention at 12 months.
Change in cerebral activity
Time Frame: 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.
Baseline and post-intervention at 12 months.
Change in brain structure
Time Frame: 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.
Baseline and post-intervention at 12 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Reserve
Time Frame: Baseline
Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve).
Baseline
Change in cardiorespiratory fitness
Time Frame: Baseline and post-intervention at 12 months.
Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)).
Baseline and post-intervention at 12 months.
Change in peripheral endothelial function
Time Frame: Baseline and post-intervention at 12 months.
Fow-mediated dilation of the brachial artery (%).
Baseline and post-intervention at 12 months.
Change in central artery stiffness
Time Frame: Baseline and post-intervention at 12 months.
Carotid femoral pulse-wave velocity (m/s).
Baseline and post-intervention at 12 months.
Change in walking speed
Time Frame: Baseline and post-intervention at 12 months.
Timed 10-meter walking test (cm/s).
Baseline and post-intervention at 12 months.
Change in functional mobility
Time Frame: Baseline and post-intervention at 12 months.
Timed Time up and Go test (s).
Baseline and post-intervention at 12 months.
Change in Balance performance
Time Frame: Baseline and post-intervention at 12 months.
Timed one-leg standing test (s).
Baseline and post-intervention at 12 months.
Change in lower limb muscles strength
Time Frame: Baseline and post-intervention at 12 months.
Timed Sit-to-Stand test (s)
Baseline and post-intervention at 12 months.
Change in upper limb muscle strength
Time Frame: Baseline and post-intervention at 12 months.
Grip strength test score (kg).
Baseline and post-intervention at 12 months.
Change in total cholesterol
Time Frame: Baseline and post-intervention at 12 months.
Total cholesterol levels (mmol/L)
Baseline and post-intervention at 12 months.
Change in cholesterol-HDL
Time Frame: Baseline and post-intervention at 12 months.
Cholesterol-HDL levels (mmol/L)
Baseline and post-intervention at 12 months.
Change in cholesterol-LDL calculated
Time Frame: Baseline and post-intervention at 12 months.
Cholesterol-LDL calculated levels (mmol/L)
Baseline and post-intervention at 12 months.
Change in cholesterol non-HDL
Time Frame: Baseline and post-intervention at 12 months.
Cholesterol non-HDL levels (mmol/L)
Baseline and post-intervention at 12 months.
Change in triglycerides
Time Frame: Baseline and post-intervention at 12 months.
Triglycerides levels (mmol/L)
Baseline and post-intervention at 12 months.
Change in glucose
Time Frame: Baseline and post-intervention at 12 months.
Glucose levels (mmol/L)
Baseline and post-intervention at 12 months.
Change in glycated hemoglobin (HbA1c)
Time Frame: Baseline and post-intervention at 12 months.
Glycated hemoglobin (HbA1c) (%)
Baseline and post-intervention at 12 months.
Change in insulin
Time Frame: Baseline and post-intervention at 12 months.
Insulin levels (pmol/L)
Baseline and post-intervention at 12 months.
Change in creatinine
Time Frame: Baseline and post-intervention at 12 months.
Creatinine levels (mg/dL)
Baseline and post-intervention at 12 months.
Change in sodium
Time Frame: Baseline and post-intervention at 12 months.
Sodium levels (mmol/L)
Baseline and post-intervention at 12 months.
Change in chloride
Time Frame: Baseline and post-intervention at 12 months.
Chloride levels (mmol/L)
Baseline and post-intervention at 12 months.
Change in potassium
Time Frame: Baseline and post-intervention at 12 months.
Potassium levels (mmol/L)
Baseline and post-intervention at 12 months.
Change in high-sensitive C-reactive protein (hsCRP)
Time Frame: Baseline and post-intervention at 12 months.
High-sensitive C-reactive protein (hsCRP) levels (mg/L)
Baseline and post-intervention at 12 months.
Change in apolipoprotein B (ApoB)
Time Frame: Baseline and post-intervention at 12 months.
Apolipoprotein B (ApoB) levels (g/L)
Baseline and post-intervention at 12 months.
Change of neurotrophic biomarkers
Time Frame: Baseline and post-intervention at 12 months.
Brain-derived neurotrophic factor (BDNF) plasma concentration (pg/mL).
Baseline and post-intervention at 12 months.
Change in transcriptomics
Time Frame: Baseline and post-intervention at 12 months.
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
Time Frame: Baseline and post-intervention at 12 months
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
Time Frame: Baseline and post-intervention at 12 months.
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
Time Frame: Baseline and post-intervention at 12 months.
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
Time Frame: Baseline and post-intervention at 12 months.
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
Time Frame: Baseline and post-intervention at 12 months.
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
Time Frame: Baseline and post-intervention at 12 months.
12-Item Short Form Health Survey (a completer).
Baseline and post-intervention at 12 months.
Change in sleep quality
Time Frame: Baseline and post-intervention at 12 months.
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
Time Frame: Baseline and post-intervention at 12 months.
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
Time Frame: Baseline and post-intervention at 12 months.
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
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline
Genotyping array to generate high quality genome-wide genotyping data that include the APOE and BDNF genes.
Baseline
Baseline level of physical activity
Time Frame: Baseline
Quantification of physical activity using an accelerometry recording of 7 days (minutes of moderate to vigorous activity).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Louis Bherer, PhD, Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aging

Clinical Trials on Cognitive Training

Subscribe