Multidomain Exercise & Cognitive Training for Aging-related Cognitive Decline

(ACTIONcR Trial)

Overseen By Louis Bherer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Louis Bherer

Disqualifiers: Dementia, Neurological disease, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 46 weeks

159 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining physical exercises, such as aerobic and resistance training, with cognitive training can improve brain function in older adults. Researchers will divide participants into groups to test different exercise plans, like aerobic workouts or stretching routines, for nearly a year. The trial seeks individuals aged 60 and older who exercise less than 150 minutes a week and have no major cognitive or physical health issues. The goal is to discover if these activities can aid thinking and memory, particularly for those with heart health concerns. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance cognitive health strategies for older adults.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both aerobic and resistance exercises safely and effectively boost brain function. Studies indicate that moderate to high-intensity exercise is generally well-tolerated. Reports of negative side effects are rare, making these exercises a safe choice for most people.

Cognitive training is also proven safe. Previous studies suggest that computer-based cognitive training safely helps older adults maintain or improve mental sharpness. This training can be done at home and has successfully addressed age-related declines in thinking skills.

In summary, both exercise and cognitive training are safe ways to enhance cognitive health in older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for aging-related cognitive decline because they combine physical and cognitive training in a unique way. Unlike standard treatments that might focus solely on cognitive exercises or medications, this approach integrates aerobic and resistance exercises with cognitive training, offering a holistic method to boost brain health. This multidomain intervention not only targets the brain but also supports overall physical health, potentially leading to more comprehensive benefits for aging individuals. Additionally, the flexibility of performing these interventions either at home or in a center makes them accessible to a wider audience, which could improve adherence and outcomes.

What evidence suggests that this trial's treatments could be effective for aging-related cognitive decline?

Research has shown that aerobic and resistance exercises, which participants in this trial may receive as part of the physical exercise intervention, can improve thinking and memory in older adults. Studies indicate that these exercises boost brain health, even for those with existing memory problems. Additionally, evidence suggests that mental exercises, similar to the cognitive training in this trial, enhance memory and reasoning skills in older people. The multidomain intervention in this trial, combining physical and mental exercises, improves decision-making and memory more effectively than a single type of exercise. This combined method has shown promising results in past studies, particularly for older adults experiencing memory decline. ^{1 3 6 7 8}

Who Is on the Research Team?

Louis Bherer, PhD

Principal Investigator

Montreal Heart Institute

Are You a Good Fit for This Trial?

This trial is for sedentary adults aged 60 and older who are generally healthy, with no cognitive impairment (scoring at least 25 on the MMSE), and have normal vision and hearing for their age. It's not suitable for those with severe cardiovascular or respiratory diseases, excessive alcohol consumption, certain heart conditions, uncontrolled mental health issues within the past six months, neurological diseases or dementia.

Inclusion Criteria

My vision and hearing are normal or corrected to normal for my age.

I am 60 years old or older.

No cognitive impairment (Mini-Mental State Examination - MMSE ≥ 25)

Exclusion Criteria

I cannot tolerate heavy physical activity.

I have symptoms from a narrowed heart valve.

I have long-term heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo aerobic and resistance training, with or without cognitive training, three sessions per week for 46 weeks

46 weeks

3 sessions per week (home-based or centre-based)

Follow-up

Participants are monitored for changes in cognitive functioning and other health metrics post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic and resistance exercises
• Cognitive Training
• Stretching and Toning

Trial Overview

The ACTIONcardioRisk trial examines if a combination of aerobic exercises, resistance training, and brain exercises can help prevent memory loss in older adults who don't exercise much but may have heart health risks. Participants will be guided through specific physical and cognitive activities.

How Is the Trial Designed?

Group I: Physical exercise intervention Experimental Treatment 1 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.

Group II: Multidomain intervention Experimental Treatment 2 Interventions

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.

Group III: Active control intervention Active Control 1 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.

Aerobic and resistance exercises is already approved in Canada for the following indications:

Approved in Canada as Aerobic-resistance exercises for:

• Prevention of cognitive decline in older adults with mild cognitive impairment

Who Is Running the Clinical Trial?

Louis Bherer

Lead Sponsor

Trials

6

Recruited

430+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

The Montreal Health Innovations Coordinating Center (MHICC)

Collaborator

Trials

14

Recruited

10,900+

Published Research Related to This Trial

Combined training of physical exercise and cognitive training in older adults shows a small advantage in improving executive functions compared to cognitive training alone, based on a meta-analysis of 50 studies involving 6,164 participants.

Engaging in both cognitive and physical exercises simultaneously, especially in social settings, leads to the largest improvements in executive functions, speed, and overall cognition, while also enhancing physical balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Combined Cognitive-Physical Interventions on Cognitive Functioning in Healthy Older Adults: A Systematic Review and Multilevel Meta-Analysis. Rieker, JA., Reales, JM., Muiños, M., et al.[2022]

The SMART trial will investigate the effects of cognitive training (CT) and progressive resistance training (PRT) on cognitive function and independence in 132 older adults at risk for cognitive decline, using a double-blind, randomized design over 6 months.

This study aims to identify not only the cognitive benefits of these interventions but also their impact on brain health, physical fitness, and overall well-being, potentially revealing mechanisms that contribute to slowing cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of Mental Activity and Regular Training (SMART) in at risk individuals: a randomised double blind, sham controlled, longitudinal trial. Gates, NJ., Valenzuela, M., Sachdev, PS., et al.[2022]

Multicomponent interventions (MCTs) combining physical exercises and cognitive training were found to be more effective than either approach alone in improving physical capacity and cognitive function in elderly individuals, with a total of 1758 participants across 17 studies.

Despite the improvements in physical and cognitive abilities, none of the MCTs were able to enhance instrumental activities of daily living (IADL), indicating a need for further research to understand how these interventions can be designed to translate cognitive and physical gains into everyday functional improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective multicomponent interventions in comparison to active control and no interventions on physical capacity, cognitive function and instrumental activities of daily living in elderly people with and without mild impaired cognition - A systematic review and network meta-analysis. Bruderer-Hofstetter, M., Rausch-Osthoff, AK., Meichtry, A., et al.[2019]

A 6-month randomized controlled trial will assess the effects of aerobic training (AT), resistance training (RT), and their combination on cognitive function in 216 older adults (ages 65-85) with mild cognitive impairment (MCI).

The study aims to determine how different types of exercise can help prevent cognitive decline and potentially delay the onset of dementia, highlighting the importance of exercise as a therapeutic intervention for cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reshaping the path of mild cognitive impairment by refining exercise prescription: a study protocol of a randomized controlled trial to understand the "what," "for whom," and "how" of exercise to promote cognitive function. Barha, CK., Falck, RS., Best, JR., et al.[2022]

The neuromotor multicomponent training program (MCTP) significantly improved executive function and functional fitness in 56 older women over a 30-week period, showing better results than both control groups in tests like the Stroop test and Timed Up and Go test.

MCTP also positively impacted body composition and health-related quality of life (HRQOL), while both exercise groups (MCTP and CONTROL-EXE) experienced reductions in blood pressure, indicating its overall health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

120 min/week of neuromotor multicomponent training are enough to improve executive function and functional fitness in older women. Martinez-Navarro, I., Cordellat, A., Roldán, A., et al.[2021]

A sequential combination of aerobic exercise and cognitive training significantly improved cognitive function in stroke survivors, as evidenced by better scores on the Montreal Cognitive Assessment and Wechsler Memory Scale compared to a control group.

While the combination training enhanced cognitive function and showed some improvement in physical endurance, it did not significantly impact social participation or quality of life, indicating that while effective for cognitive gains, further strategies may be needed to address broader health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Active Ingredient of Cognitive Restoration: A Multicenter Randomized Controlled Trial of Sequential Combination of Aerobic Exercise and Computer-Based Cognitive Training in Stroke Survivors With Cognitive Decline. Yeh, TT., Chang, KC., Wu, CY.[2020]

Cognitive training and physical exercise can enhance cognitive performance and physical functioning in older adults, with exercise showing significant improvements in physical capacity and some cognitive domains, regardless of frailty status.

While cognitive training may have limited transfer effects to untrained tasks, computerized dual-task training has been effective in improving balance and postural control, indicating that certain training methods can lead to broader benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive plasticity in older adults: effects of cognitive training and physical exercise. Bherer, L.[2022]

A systematic review of 14 studies involving 988 seniors found that both interval aerobic training (IAT) and continuous aerobic training (CAT) can increase levels of brain-derived neurotrophic factor (BDNF), which is important for brain health.

The effectiveness of aerobic training on BDNF levels is influenced more by factors like training intensity, frequency, and duration rather than the type of training, suggesting that a variety of aerobic exercises can be beneficial for seniors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Interval and Continuous Aerobic Training on Basal Serum and Plasma Brain-Derived Neurotrophic Factor Values in Seniors: A Systematic Review of Intervention Studies. Enette, L., Vogel, T., Fanon, JL., et al.[2018]

Regular aerobic exercise and possibly resistance training can significantly enhance cognitive performance and help counteract age-related declines in brain function.

Different types of exercise, including aerobic and resistance training, activate various physiological mechanisms that contribute to cognitive improvements, but more research is needed to determine the optimal amount and type of exercise for maximum benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Strategies to Counteract Brain Aging Effects. Szalewska, D., Radkowski, M., Demkow, U., et al.[2019]

A 3-month community-based aerobic exercise training program showed a trend toward improved cardiorespiratory fitness (CRF) in individuals with traumatic brain injury (TBI), with an 8% increase in VO2peak compared to a 4% decrease in a stretching and toning group, indicating potential efficacy of aerobic exercise for this population.

The study demonstrated that while it is feasible to conduct exercise training in community settings for TBI patients, only 50% of participants adhered to the program, highlighting the need for strategies to improve adherence in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. Ding, K., Tarumi, T., Tomoto, T., et al.[2021]

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