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

Louis Bherer

Status: Enrolling

Conditions: Aging; Cardiovascular Risk Factor

Treatments: Other: Cognitive Training; Other: Stretching and Toning; Other: Aerobic and resistance exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT04962061

2019-2545

Details and patient eligibility

About

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.

Full 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.

Enrollment: 159 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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159 participants in 3 patient groups

Multidomain intervention

Experimental group

Description:

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.

Treatment:

Other: Aerobic and resistance exercises

Other: Cognitive Training

Physical exercise intervention

Experimental group

Description:

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.

Treatment:

Other: Aerobic and resistance exercises

Active control intervention

Active Comparator group

Description:

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.

Treatment:

Other: Stretching and Toning