A Combined Multidomain Intervention to Prevent Cognitive Decline Associated With Cardiovascular Risk Factors.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorLouis Bherer

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

MMSE ≤ 24 or diagnosis of dementia,

Uncontrolled psychological / psychiatric condition within the past 6 months,

Neurological disease,

Severe exercise intolerance,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive Training

    Other intervention

    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.

  • Aerobic and resistance exercises

    Other intervention

    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.

  • Stretching and Toning

    Other intervention

    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).

Treatment groups

159 Participants
are divided into 3 treatment groups
Group A: Multidomain interventionExperimental treatment 2 interventions
Group B: Physical exercise interventionExperimental treatment 1 intervention
Group C: Active control interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in general cognitive functioning

Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).

Time frame
Baseline and post-intervention at 12 months.
2

Change in processing speed

Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).

Time frame
Baseline and post-intervention at 12 months.
3

Change in executive functions

Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).

Time frame
Baseline and post-intervention at 12 months.
4

Change in episodic memory

Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).

Time frame
Baseline and post-intervention at 12 months.

Secondary outcomes

1

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.

Time frame
Baseline and post-intervention at 12 months.
2

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.

Time frame
Baseline and post-intervention at 12 months.
3

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.

Time frame
Baseline and post-intervention at 12 months.
4

Change in cerebral vasoreactivity - prefrontal cortex

Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using NIRS in the prefrontal region.

Time frame
Baseline and post-intervention at 12 months.

Other outcomes

1

Change in cardiorespiratory fitness

Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)).

Time frame
Baseline and post-intervention at 12 months.
2

Change in peripheral endothelial function

Fow-mediated dilation of the brachial artery (%).

Time frame
Baseline and post-intervention at 12 months.
3

Change in central artery stiffness

Carotid femoral pulse-wave velocity (m/s).

Time frame
Baseline and post-intervention at 12 months.
4

Change in walking speed

Timed 10-meter walking test (cm/s).

Time frame
Baseline and post-intervention at 12 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Louis Bherer

Lead sponsor

Montreal Heart Institute

Sponsor institution

Canadian Institutes of Health Research (CIHR)

Collaborator

The Montreal Health Innovations Coordinating Center (MHICC)

Collaborator