The Cognitive and spOrt Virtual EPIC Training Study

NCT04635462 | Completed DMC

• 1 other identifier: 2020-2785
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed COVEPIC trial is designed to document the effects of remote monitoring of physical exercise and home-based cognitive training on cognitive and physical functions in older adults.

Conditions

Aging

Keywords

Aging; Remote monitoring; Home-based training; Cognitive Training; Physical Exercise; Cognition

Outcome Measures

Primary Outcomes (4)

• Change in general cognitive functioning

  Validated remote version of Montreal Cognitive Assessment (0-28 score, with a higher score indicating a better cognitive functioning).

  Baseline and post-intervention at 6 months.

• Change in executive functions

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

  Baseline and post-intervention at 6 months.

• Change in processing speed

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

  Baseline and post-intervention at 6 months.

• Change in episodic memory

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

  Baseline and post-intervention at 6 months.

Secondary Outcomes (5)

• Change in Walking speed

  Baseline and post-intervention at 6 months.

• Change in Functional mobility

  Baseline and post-intervention at 6 months.

• Change in Balance performance

  Baseline and post-intervention at 6 months.

• Change in Lower limb muscles strength

  Baseline and post-intervention at 6 months.

• Change in Cardiorespiratory fitness

  Baseline and post-intervention at 6 months.

Other Outcomes (17)

• Change in Quality-of-life

  Baseline and post-intervention at 6 months.

• Change in Depressive symptomatology

  Baseline and post-intervention at 6 months.

• Change in Anxiety

  Baseline and post-intervention at 6 months.

Study Arms (2)

Multidomain intervention

EXPERIMENTAL

The multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month.

Other: Physical exercise training; Other: Cognitive training

Physical exercise intervention

EXPERIMENTAL

The physical exercises intervention will include the remote monitoring of physical exercise training for 6-month.

Other: Physical exercise training

Interventions

Physical exercise training OTHER

Participants will be encouraged to complete exercise training programs in the form of video capsules available via Facebook or Youtube, created by kinesiologists of the Montreal Heart Institut EPIC prevention center. The videos last about 15 minutes and include a warm-up of 3 to 5 minutes, followed a 10-minute training and finally a 2-minute cool-down period. The exercises on video do not require any equipment and integrate, depending on the video, aerobic, muscular strengthening, flexibility and/or balance exercises. Several intensities are described according to the participants' level. Participants will be invited to perform exercise sessions at least 5 times a week, and will be monitored weekly by phone by a member of the research team. The exercise sessions can be performed at home using the video training program, as well as in sports centre or outdoors. For each session, participants have to report its duration, intensity, and the nature of the activity via a follow-up agenda.

Multidomain intervention; Physical exercise intervention

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 different mnemotechnic, as well as be taught about memory in aging in general. The memory training will be provided by videos capsules. To track adherence to cognitive training, participants will be asked to complete a journal and mark days and times where they took part in the various cognitive training sessions.

Multidomain intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged 50 and older
• Have access to internet
• Have access to a tablet (i.e. iPad or Android) or a computer

You may not qualify if:

• Non-cardiopulmonary limitation to exercise (e.g., arthritis)
• Severe exercise intolerance
• Respiratory disease (e.g., asthma, COPD, COVID-19)
• Mini Mental Scale Examination (MMSE) telephone version lower than 19/23
• Diagnostic of cardiovascular disease (e.g., chronic systolic and diastolic heart failure, somatic aortic stenosis, atrial fibrillation, malignant arrhythmias, documented atherosclerotic disease).

Sponsors & Collaborators

• Louis Bherer: lead

Study Sites (1)

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

Montreal, Quebec, H1T1N6, Canada

Location

Related Publications (23)

• Brooks SK, Webster RK, Smith LE, Woodland L, Wessely S, Greenberg N, Rubin GJ. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020 Mar 14;395(10227):912-920. doi: 10.1016/S0140-6736(20)30460-8. Epub 2020 Feb 26.

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• Jimenez-Pavon D, Carbonell-Baeza A, Lavie CJ. Physical exercise as therapy to fight against the mental and physical consequences of COVID-19 quarantine: Special focus in older people. Prog Cardiovasc Dis. 2020 May-Jun;63(3):386-388. doi: 10.1016/j.pcad.2020.03.009. Epub 2020 Mar 24. No abstract available.

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• Chen P, Mao L, Nassis GP, Harmer P, Ainsworth BE, Li F. Coronavirus disease (COVID-19): The need to maintain regular physical activity while taking precautions. J Sport Health Sci. 2020 Mar;9(2):103-104. doi: 10.1016/j.jshs.2020.02.001. Epub 2020 Feb 4. No abstract available.

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• Bherer L, Erickson KI, Liu-Ambrose T. A review of the effects of physical activity and exercise on cognitive and brain functions in older adults. J Aging Res. 2013;2013:657508. doi: 10.1155/2013/657508. Epub 2013 Sep 11.

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• 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.

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• Bherer L. Cognitive plasticity in older adults: effects of cognitive training and physical exercise. Ann N Y Acad Sci. 2015 Mar;1337:1-6. doi: 10.1111/nyas.12682.

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• Dupuy O, Gauthier CJ, Fraser SA, Desjardins-Crepeau L, Desjardins M, Mekary S, Lesage F, Hoge RD, Pouliot P, Bherer L. Higher levels of cardiovascular fitness are associated with better executive function and prefrontal oxygenation in younger and older women. Front Hum Neurosci. 2015 Feb 18;9:66. doi: 10.3389/fnhum.2015.00066. eCollection 2015.

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• Renaud M, Bherer L, Maquestiaux F. A high level of physical fitness is associated with more efficient response preparation in older adults. J Gerontol B Psychol Sci Soc Sci. 2010 May;65B(3):317-22. doi: 10.1093/geronb/gbq004. Epub 2010 Feb 5.

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• Predovan D, Fraser SA, Renaud M, Bherer L. The effect of three months of aerobic training on stroop performance in older adults. J Aging Res. 2012;2012:269815. doi: 10.1155/2012/269815. Epub 2012 Dec 11.

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• Renaud M, Maquestiaux F, Joncas S, Kergoat MJ, Bherer L. The effect of three months of aerobic training on response preparation in older adults. Front Aging Neurosci. 2010 Nov 11;2:148. doi: 10.3389/fnagi.2010.00148. eCollection 2010.

  PMID: 21151355 BACKGROUND

• Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.

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• Gross AL, Parisi JM, Spira AP, Kueider AM, Ko JY, Saczynski JS, Samus QM, Rebok GW. Memory training interventions for older adults: a meta-analysis. Aging Ment Health. 2012;16(6):722-34. doi: 10.1080/13607863.2012.667783.

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  PMID: 12425704 BACKGROUND

• 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.

  PMID: 16420143 BACKGROUND

• Lussier M, Gagnon C, Bherer L. An investigation of response and stimulus modality transfer effects after dual-task training in younger and older. Front Hum Neurosci. 2012 May 18;6:129. doi: 10.3389/fnhum.2012.00129. eCollection 2012.

  PMID: 22629239 BACKGROUND

• Payne BR, Stine-Morrow EAL. The Effects of Home-Based Cognitive Training on Verbal Working Memory and Language Comprehension in Older Adulthood. Front Aging Neurosci. 2017 Aug 8;9:256. doi: 10.3389/fnagi.2017.00256. eCollection 2017.

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• Zhu X, Yin S, Lang M, He R, Li J. The more the better? A meta-analysis on effects of combined cognitive and physical intervention on cognition in healthy older adults. Ageing Res Rev. 2016 Nov;31:67-79. doi: 10.1016/j.arr.2016.07.003. Epub 2016 Jul 14.

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• Roccaforte WH, Burke WJ, Bayer BL, Wengel SP. Validation of a telephone version of the mini-mental state examination. J Am Geriatr Soc. 1992 Jul;40(7):697-702. doi: 10.1111/j.1532-5415.1992.tb01962.x.

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• Pendlebury ST, Welch SJ, Cuthbertson FC, Mariz J, Mehta Z, Rothwell PM. Telephone assessment of cognition after transient ischemic attack and stroke: modified telephone interview of cognitive status and telephone Montreal Cognitive Assessment versus face-to-face Montreal Cognitive Assessment and neuropsychological battery. Stroke. 2013 Jan;44(1):227-9. doi: 10.1161/STROKEAHA.112.673384. Epub 2012 Nov 8.

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• Matthews CE, Heil DP, Freedson PS, Pastides H. Classification of cardiorespiratory fitness without exercise testing. Med Sci Sports Exerc. 1999 Mar;31(3):486-93. doi: 10.1097/00005768-199903000-00019.

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• Belleville S, Hudon C, Bier N, Brodeur C, Gilbert B, Grenier S, Ouellet MC, Viscogliosi C, Gauthier S. MEMO+: Efficacy, Durability and Effect of Cognitive Training and Psychosocial Intervention in Individuals with Mild Cognitive Impairment. J Am Geriatr Soc. 2018 Apr;66(4):655-663. doi: 10.1111/jgs.15192. Epub 2018 Jan 4.

  PMID: 29313875 BACKGROUND

• Dupuy EG, Besnier F, Gagnon C, Vincent T, Vrinceanu T, Blanchette CA, Gervais J, Breton J, Saillant K, Iglesies-Grau J, Belleville S, Juneau M, Vitali P, Nigam A, Gayda M, Bherer L. Effects of home-based exercise alone or combined with cognitive training on cognition in community-dwelling older adults: A randomized clinical trial. Exp Gerontol. 2024 Dec;198:112628. doi: 10.1016/j.exger.2024.112628. Epub 2024 Nov 9.

  PMID: 39505286 DERIVED

• Dupuy EG, Besnier F, Gagnon C, Vincent T, Gregoire CA, Blanchette CA, Saillant K, Bouabdallaoui N, Iglesies-Grau J, Payer M, Marin MF, Belleville S, Juneau M, Vitali P, Gayda M, Nigam A, Bherer L. COVEPIC (Cognitive and spOrt Virtual EPIC training) investigating the effects of home-based physical exercise and cognitive training on cognitive and physical functions in community-dwelling older adults: study protocol of a randomized single-blinded clinical trial. Trials. 2021 Jul 29;22(1):505. doi: 10.1186/s13063-021-05476-2.

  PMID: 34325710 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Cognitive Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This clinical trial is a single-blinded study. Research personnel performing the outcome assessments at baseline, three, six and twelve months will be blinded to group allocation. Participants will be aware of the type of training they receive.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate scientific director, Direction of prevention, Montreal Heart Institute

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 19, 2020
• Study Start: May 18, 2020
• Primary Completion: October 15, 2021
• Study Completion: May 18, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)