Multidomain Exercise & Cognitive Training for Aging-related Cognitive Decline
(ACTIONcR Trial)
Recruiting in Palo Alto (17 mi)
Overseen byLouis Bherer, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Louis Bherer
Disqualifiers: Dementia, Neurological disease, Heart failure, others
No Placebo Group
Trial Summary
What is the purpose of 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.
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.
What data supports the effectiveness of this treatment for aging-related cognitive decline?
Research shows that combining physical exercise and cognitive training can help maintain and improve cognitive functions in older adults. Studies indicate that this combined approach can enhance executive functions, balance, and overall cognitive health, making it a promising non-drug option for addressing cognitive decline in aging individuals.
12345Is the multidomain exercise and cognitive training generally safe for humans?
Research indicates that aerobic and resistance exercises, as well as cognitive training, are generally safe for older adults, including those with mild cognitive impairment and traumatic brain injury, with no reported adverse events in studies.
16789How does the Multidomain Exercise & Cognitive Training treatment differ from other treatments for aging-related cognitive decline?
This treatment is unique because it combines aerobic and resistance exercises with cognitive training, which may provide additive benefits for cognitive function and physical balance compared to single interventions. It targets both physical and cognitive aspects simultaneously, potentially offering broader improvements in executive functions and overall cognition.
456710Eligibility Criteria
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)
+1 more
Exclusion Criteria
I cannot tolerate heavy physical activity.
I have symptoms from a narrowed heart valve.
I have long-term heart failure.
+10 more
Trial Timeline
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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Physical exercise interventionExperimental Treatment1 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 interventionExperimental Treatment2 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 interventionActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart InstituteMontreal, Canada
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Who Is Running the Clinical Trial?
Louis BhererLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
The Montreal Health Innovations Coordinating Center (MHICC)Collaborator
References
120 min/week of neuromotor multicomponent training are enough to improve executive function and functional fitness in older women. [2021]The study aimed at comparing the effects of a neuromotor multicomponent training program (MCTP) on executive function, functional fitness, blood pressure, body composition and health-related quality of life (HRQOL), compared with a concurrent strength and endurance exercise training program (CONTROL-EXE) and a cognitive training program (CONTROL-COG).
Study of Mental Activity and Regular Training (SMART) in at risk individuals: a randomised double blind, sham controlled, longitudinal trial. [2022]The extent to which mental and physical exercise may slow cognitive decline in adults with early signs of cognitive impairment is unknown. This article provides the rationale and methodology of the first trial to investigate the isolated and combined effects of cognitive training (CT) and progressive resistance training (PRT) on general cognitive function and functional independence in older adults with early cognitive impairment: Study of Mental and Regular Training (SMART). Our secondary aim is to quantify the differential adaptations to these interventions in terms of brain morphology and function, cardiovascular and metabolic function, exercise capacity, psychological state and body composition, to identify the potential mechanisms of benefit and broader health status effects.
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. [2020]To investigate the efficacy of a sequential combination of aerobic exercise and cognitive training on cognitive function and other health-related outcomes in stroke survivors with cognitive decline.
The Effects of Combined Cognitive-Physical Interventions on Cognitive Functioning in Healthy Older Adults: A Systematic Review and Multilevel Meta-Analysis. [2022]Research has shown that both physical exercise and cognitive training help to maintain cognition in older adults. The question is whether combined training might produce additive effects when the group comparisons are equated in terms of exercise intensity and modality. We conducted a systematic electronic search in MEDLINE, PsycInfo, and Cochrane Central Register of Controlled Trials (CENTRAL) databases to identify relevant studies published up to February 2021. Seven hundred and eighty-three effect sizes were obtained from 50 published intervention studies, involving 6,164 healthy older adults, and submitted to a three-level meta-analysis. Results showed that combined training produced a small advantage in comparison to single cognitive training on executive functions, whereas both types of training achieved similar effects on attention, memory, language, processing speed, and global cognition. Combined training achieved higher training gains in balance than single physical training, indicating a transfer from cognitive training to balance. Performing cognitive and physical exercise simultaneously, and interactive training (e.g., exergames, square stepping) produced the largest gains in executive functions, speed, and global cognition, as well as the largest improvements in physical functions. Aerobic training was associated with higher effects in attention and fitness, whereas non-aerobic training produced larger effects in global cognition and balance. For all cognitive and physical outcomes, training resulted more advantageous when performed in a social context, even though individual training obtained similar results in balance as group training. Systematic Review Registration: www.crd.york.ac.uk/prospero/, identifier: CRD42020175632.
Cognitive plasticity in older adults: effects of cognitive training and physical exercise. [2022]Cognitive training, physical activity, and exercise have often been reported to improve cognitive performance in older adults. This paper reviews some seminal and recent studies using these approaches to improve cognition and physical functioning in healthy older adults and in patients suffering from non-neurological chronic medical conditions. Results from cognitive training studies suggest that despite performance improvement in trained tasks, transfer effects appeared very limited. Surprisingly though, computerized dual-task training has been shown to improve balance and postural control in tests of physical functioning, suggesting that broad transfer can sometimes be observed. Physical exercise intervention studies generally found significant and large improvements in physical capacity, in some cognitive domains, and in quality of life. The benefits seem to be equivalent between frail and nonfrail participants. Overall, results reviewed here support the notion that cognitive plasticity for attentional control, as induced by cognitive training or physical activity and exercise, is preserved in late adulthood. Moreover, results of studies with patients at risk of cognitive decline also suggest that cognitive training and exercise interventions are promising nonpharmaceutical tools to help improve cognition in older at-risk individuals.
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. [2022]Targeted exercise training is a promising strategy for promoting cognitive function and preventing dementia in older age. Despite the utility of exercise as an intervention, variation still exists in exercise-induced cognitive gains and questions remain regarding the type of training (i.e., what), as well as moderators (i.e., for whom) and mechanisms (i.e., how) of benefit. Both aerobic training (AT) and resistance training (RT) enhance cognitive function in older adults without cognitive impairment; however, the vast majority of trials have focused exclusively on AT. Thus, more research is needed on RT, as well as on the combination of AT and RT, in older adults with mild cognitive impairment (MCI), a prodromal stage of dementia. Therefore, we aim to conduct a 6-month, 2 × 2 factorial randomized controlled trial in older adults with MCI to assess the individual effects of AT and RT, and the combined effect of AT and RT on cognitive function and to determine the possible underlying biological mechanisms.
Exercise Strategies to Counteract Brain Aging Effects. [2019]Stimulating structural and functional adaptation that improves cognitive performance in specific tasks is the major objective of therapeutic exercise training. In this review we briefly summarize central physiological mechanisms activated by exercise. We further discuss the influence of different kinds of exercise on cognitive improvement. In particular, the effects on cognitive function of aerobic endurance, resistance and respiratory exercise, and combinations thereof are presented. The accumulating evidence reinforces the position that regular aerobic, and possibly also resistance training, offers a powerful tool to cope with biologic aging of central nervous system functions. Nevertheless, the potential magnitude of cognition improvement or restrain of age-related cognition deterioration and the quantity of physical activity required to induce meaningful responses remain to be clarified.
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. [2018]The purpose of this systematic review was to provide a comprehensive analysis of the available clinical trials analyzing, in seniors, the effect of interval aerobic training (IAT) and continuous aerobic training (CAT) on peripheral brain-derived neurotrophic factor (BDNF) concentration. We identified 14 randomized or not-randomized intervention studies published up to January 2017 through a computer-assisted search (PUBMED, Pedro, and Science direct data bases). The five trials considering IAT and the nine considering CAT totalized 988 individuals (age range: 58.1-77 years). The parameters of aerobic training (AT) protocol in terms of frequency and intensity are the primary determinants of the BDNF response to AT. The interpretation of the relationship between AT and BDNF signaling pathway was very challenging when specific health conditions were taken into consideration. This was more particularly true with mild cognitive impairment or depressive symptoms. These findings argue in favor of a generalization of the practice of AT and show that the type of training is not the main determining factor of the increase in BDNF level, which results more from the combination of several factors such as intensity and frequency of sessions, duration of programs, and also some genetic determinant coding for BDNF protein. All these factors have to be carefully addressed in future researches in that field. Thus, further researches are still necessary to better the signaling pathway by which AT contributes to better health outcomes.
A proof-of-concept trial of a community-based aerobic exercise program for individuals with traumatic brain injury. [2021]Objective: To assess the feasibility of conducting an aerobic exercise training study in a community setting for individuals with traumatic brain injury (TBI)Methods: This is a prospective, randomized, and controlled study. Nine participants (three moderate-to-severe and six mild TBI) were randomized to a community-based 3-month individualized aerobic exercise training program (AET). Seven participants (four moderate-to-severe, three mild TBI) were randomized to a stretching and toning program (SAT). Cardiorespiratory fitness (CRF) level was assessed with peak oxygen uptake (VO2peak) testing.Results: After 3 months of training, the AET trended toward improved VO2peak when compared with the SAT group (8% vs - 4%, p = .059) with a large effect size of 1.27. Only 50% of participants in the AET group completed more than 70% of the assigned exercise sessions. No adverse events were reported. Both the AET and SAT groups reported small improvements in self-reported mood symptoms, including depression, anxiety, and anger.Conclusions: It is feasible to conduct an exercise training study and improve CRF for persons with TBI in community settings with structured exercise protocols. However, exploring methods to enhance adherence is crucial for future exercise clinical trials to improve brain health in this population.
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. [2019]Multicomponent interventions (MCT) combine physical exercises and cognitive training and seem to be most effective in improving cognition in elderly people. However, literature is inconclusive if MCTs are superior to active comparison interventions, if delivery modes matter, and if people can transfer achieved effects to instrumental activities of daily living (IADL). This network meta-analysis aimed to a) identify MCTs that were effective on physical capacity and/or cognitive function and able to transfer these effects into IADL in elderly people with normal cognition (NC) and mild cognitive impairment (MCI); b) provide a rating on the best interventions per outcome; c) evaluate MCTs' mode of delivery. Eligible studies were randomized controlled trials comparing MCTs to active comparison or no treatments. Six studies in participants with MCI (n = 1088) and eleven studies in participants with NC (n = 670) were included. Five effective MCTs that were superior to physical exercises or cognitive training alone in improving physical capacity and/or cognitive function were detected, however none of these MCTs improved IADL. In people with NC MCTs performed separately or simultaneously were effective. However, in people with MCI MCTs performed separately were more effective. A framework needs to be developed to better understand the mediating effects of physical capacity and cognitive function on IADL and to design MCTs that effectively improve IADL.