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

NCT04962061 | Recruiting DMC

• 1 other identifier: 2019-2545
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Cardiovascular Risk Factor

Keywords

Aging; Cardiovascular Risk factor; Cognition; Combined Intervention; Cognitive Training; Physical Exercise; Brain Functions; Biomarkers

Outcome Measures

Primary Outcomes (4)

• 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.

Secondary Outcomes (9)

• Change in cerebral autoregulation - frontal cortical region

  Baseline and post-intervention at 12 months.

• Change in cerebral autoregulation - middle cerebral arteries

  Baseline and post-intervention at 12 months.

• Change in cerebral vasoreactivity - whole brain

  Baseline and post-intervention at 12 months.

• Change in cerebral vasoreactivity - prefrontal cortex

  Baseline and post-intervention at 12 months.

• Change in cerebral vasoreactivity - middle cerebral arteries

  Baseline and post-intervention at 12 months.

Other Outcomes (38)

• Change in cardiorespiratory fitness

  Baseline and post-intervention at 12 months.

• Change in peripheral endothelial function

  Baseline and post-intervention at 12 months.

• Change in central artery stiffness

  Baseline and post-intervention at 12 months.

Study Arms (3)

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.

Other: Cognitive Training; Other: Aerobic and resistance exercises

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.

Other: Aerobic and resistance exercises

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.

Other: Stretching and Toning

Interventions

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.

Multidomain intervention

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.

Multidomain intervention; Physical exercise intervention

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).

Active control intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Louis Bherer: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• The Montreal Health Innovations Coordinating Center (MHICC): collaborator

Study Sites (1)

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

RECRUITING

Related Publications (24)

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  PMID: 40625372 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Louis Bherer, PhD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis Bherer, PhD

CONTACT

514-374-1480; louis.bherer@umontreal.ca

Anil Nigam, MD

CONTACT

514-376-3330; anil.nigam@icm-mhi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the EPIC Center and Scientist, Montreal Heart Institute

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 14, 2021
• Study Start: September 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)