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AgingACTIONcRNCT04962061

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

A study testing Cognitive Training, Aerobic and resistance exercises and Stretching and Toning in people with Aging and Cardiovascular Risk Factor, run by Louis Bherer at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Aging, Cardiovascular Risk Factor
What is being tested?
Cognitive Training, Aerobic and resistance exercises and Stretching and Toning
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
1 siteCanada
Study dates
1 Sep 2021to 3 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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),
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country.

Canada1 site

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

    Montreal, Quebec, H1T1N6

Other trials in Canada

About this study

Official title: Impacts of Aerobic, Resistance and Cognitive Training Interventions on Neurocognitive Functions in Older Adults With Cardiovascular Risk Factors.

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.

Read the detailed 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.

Being tested
Cognitive Training, Aerobic and resistance exercises, Stretching and Toning
Keywords
Aging, Cardiovascular Risk factor, Cognition, Combined Intervention, Cognitive Training, Physical Exercise, Brain Functions, Biomarkers
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive TrainingOther

    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 exercisesOther

    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 ToningOther

    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).

Study groups in NCT04962061
Study groupRoleWhat they receive
Multidomain interventionExperimentalThe 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.
Receives: Other: Cognitive Training; Other: Aerobic and resistance exercises
Physical exercise interventionExperimentalThe 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.
Receives: Other: Aerobic and resistance exercises
Active control interventionActive comparatorThe 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.
Receives: Other: Stretching and Toning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in general cognitive functioning

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

    Measured: Baseline and post-intervention at 12 months.

  2. Change in processing speed

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

    Measured: Baseline and post-intervention at 12 months.

  3. Change in executive functions

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

    Measured: Baseline and post-intervention at 12 months.

  4. Change in episodic memory

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

    Measured: Baseline and post-intervention at 12 months.

Secondary outcomes (9)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and post-intervention at 12 months.

  5. Change in cerebral vasoreactivity - middle cerebral arteries

    Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using TCD in the middle cerebral arteries

    Measured: Baseline and post-intervention at 12 months.

  6. Change in cerebral pulsatility - cortical frontal region

    Pulsatility will be measured as the normalized difference of relative near-infrared light intensity changes between systole and diastole, using NIRS in the prefrontal cortical region.

    Measured: Baseline and post-intervention at 12 months.

  7. Change in cerebral pulsatility - middle cerebral arteries

    Pulsatility will be measured as the normalized difference of relative blood flow velocities between systole and diastole, using TCD in the middle cerebral arteries.

    Measured: Baseline and post-intervention at 12 months.

  8. Change in cerebral activity

    Significant changes in brain activity evoked by a Stroop task relative to baseline will be assessed by t-statistics maps, computed from variations of [HbO] and [HbR] measured by NIRS at the prefrontal cortex.

    Measured: Baseline and post-intervention at 12 months.

  9. Change in brain structure

    Multimodal structural MRI will be performed in two third of the study participants who do not present contra-indication for imaging studies, to measure regional cerebral volumes, as well as volume of angiopathic markers (eg lacunes, microbleeds, white matter hyperintensities), in cm3.

    Measured: Baseline and post-intervention at 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2021
  2. Study start1 Sep 2021
  3. Primary completion6 Feb 2026
  4. Study completion3 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04962061
Sponsor's protocol ID
2019-2545
Acronym
ACTIONcR
Status last verified
Aug 2026
First submitted
16 Jun 2021
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arntzen KA, Schirmer H, Wilsgaard T, Mathiesen EB. Impact of cardiovascular risk factors on cognitive function: the Tromso study. Eur J Neurol. 2011 May;18(5):737-43. doi: 10.1111/j.1468-1331.2010.03263.x. Epub 2010 Dec 8.

    PubMed 21143340

  • Baker LD, Frank LL, Foster-Schubert K, Green PS, Wilkinson CW, McTiernan A, Cholerton BA, Plymate SR, Fishel MA, Watson GS, Duncan GE, Mehta PD, Craft S. Aerobic exercise improves cognition for older adults with glucose intolerance, a risk factor for Alzheimer's disease. J Alzheimers Dis. 2010;22(2):569-79. doi: 10.3233/JAD-2010-100768.

    PubMed 20847403

  • Bherer L, Kramer AF, Peterson MS, Colcombe S, Erickson K, Becic E. Training effects on dual-task performance: are there age-related differences in plasticity of attentional control? Psychol Aging. 2005 Dec;20(4):695-709. doi: 10.1037/0882-7974.20.4.695.

    PubMed 16420143

  • Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.

    PubMed 12661673

  • DeRight J, Jorgensen RS, Cabral MJ. Composite cardiovascular risk scores and neuropsychological functioning: a meta-analytic review. Ann Behav Med. 2015 Jun;49(3):344-57. doi: 10.1007/s12160-014-9681-0.

    PubMed 25616781

  • Dregan A, Stewart R, Gulliford MC. Cardiovascular risk factors and cognitive decline in adults aged 50 and over: a population-based cohort study. Age Ageing. 2013 May;42(3):338-45. doi: 10.1093/ageing/afs166. Epub 2012 Nov 25.

    PubMed 23179255

  • Erickson KI, Colcombe SJ, Wadhwa R, Bherer L, Peterson MS, Scalf PE, Kim JS, Alvarado M, Kramer AF. Training-induced functional activation changes in dual-task processing: an FMRI study. Cereb Cortex. 2007 Jan;17(1):192-204. doi: 10.1093/cercor/bhj137. Epub 2006 Feb 8.

    PubMed 16467562

  • Eskelinen MH, Ngandu T, Helkala EL, Tuomilehto J, Nissinen A, Soininen H, Kivipelto M. Fat intake at midlife and cognitive impairment later in life: a population-based CAIDE study. Int J Geriatr Psychiatry. 2008 Jul;23(7):741-7. doi: 10.1002/gps.1969.

    PubMed 18188871

  • Friedman JI, Tang CY, de Haas HJ, Changchien L, Goliasch G, Dabas P, Wang V, Fayad ZA, Fuster V, Narula J. Brain imaging changes associated with risk factors for cardiovascular and cerebrovascular disease in asymptomatic patients. JACC Cardiovasc Imaging. 2014 Oct;7(10):1039-53. doi: 10.1016/j.jcmg.2014.06.014.

    PubMed 25323165

  • Hodyl NA, Schneider L, Vallence AM, Clow A, Ridding MC, Pitcher JB. The cortisol awakening response is associated with performance of a serial sequence reaction time task. Int J Psychophysiol. 2016 Feb;100:12-8. doi: 10.1016/j.ijpsycho.2015.12.007. Epub 2015 Dec 22.

    PubMed 26721740

  • Jennings JR, Muldoon MF, Ryan C, Price JC, Greer P, Sutton-Tyrrell K, van der Veen FM, Meltzer CC. Reduced cerebral blood flow response and compensation among patients with untreated hypertension. Neurology. 2005 Apr 26;64(8):1358-65. doi: 10.1212/01.WNL.0000158283.28251.3C.

    PubMed 15851723

  • Karssemeijer EGA, Aaronson JA, Bossers WJ, Smits T, Olde Rikkert MGM, Kessels RPC. Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Ageing Res Rev. 2017 Nov;40:75-83. doi: 10.1016/j.arr.2017.09.003. Epub 2017 Sep 12.

    PubMed 28912076

  • Kobe T, Witte AV, Schnelle A, Lesemann A, Fabian S, Tesky VA, Pantel J, Floel A. Combined omega-3 fatty acids, aerobic exercise and cognitive stimulation prevents decline in gray matter volume of the frontal, parietal and cingulate cortex in patients with mild cognitive impairment. Neuroimage. 2016 May 1;131:226-38. doi: 10.1016/j.neuroimage.2015.09.050. Epub 2015 Oct 1.

    PubMed 26433119

  • Launer LJ, Lewis CE, Schreiner PJ, Sidney S, Battapady H, Jacobs DR, Lim KO, D'Esposito M, Zhang Q, Reis J, Davatzikos C, Bryan RN. Vascular factors and multiple measures of early brain health: CARDIA brain MRI study. PLoS One. 2015 Mar 26;10(3):e0122138. doi: 10.1371/journal.pone.0122138. eCollection 2015.

    PubMed 25812012

  • Lupien SJ, Maheu F, Tu M, Fiocco A, Schramek TE. The effects of stress and stress hormones on human cognition: Implications for the field of brain and cognition. Brain Cogn. 2007 Dec;65(3):209-37. doi: 10.1016/j.bandc.2007.02.007. Epub 2007 Apr 26.

    PubMed 17466428

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Training, Aerobic and resistance exercises and Stretching and Toning in people with Aging and Cardiovascular Risk Factor, run by Louis Bherer at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in general cognitive functioning (time frame: Baseline and post-intervention at 12 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04962061, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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