The Cognitive and spOrt Virtual EPIC Training Study (COVEPIC)

The Cognitive and spOrt Virtual EPIC Training Study: INVESTIGATING THE EFFECTS OF HOME-BASED EXERCISE AND COGNITIVE TRAINING

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.

Study Overview

• Status: Recruiting
• Conditions: Aging
• Intervention / Treatment: Other: Physical exercise training; Other: Cognitive training

Detailed Description

Due to the actual pandemic of COVID-19 around the world, social distancing is recommended, which causes a reduction of social interaction and physical activity. Therefore, this health crisis may have collateral effects on cognitive, physical, and psychological health, especially in elderly people who are more likely to be isolated, and for whom social distancing is of paramount importance. Physical exercise practice has been demonstrated to improve cognitive functioning, along with mobility and physical capacity, and to promote psychological well-being. This is the reason why governmental health authorities, as well as the scientific community recommend to stay physically active, especially in this pandemic period. However, in the current context full-time physical training in sport centres cannot be largely promoted. Effective solutions to help older adults in maintaining regular and efficient physical exercise while maintaining social distancing, are thus needed. Consequently, the current project proposes first to investigate the potential of a remote monitoring of physical activity to promote cognitive, physical and psychological health of older adults. Also, considering the added benefits of combining cognitive training to physical exercise to further enhance health and cognition in seniors, this project also addresses the added benefits of a multidomain intervention combining a physical exercise intervention with a home-based cognitive training.

• Study Type: Interventional
• Enrollment (Anticipated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma G Dupuy, PhD; Phone Number: 4345 514-374-1480; Email: emma.dupuy@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T1N6
      • Recruiting
      • Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
      • Contact: Emma G Dupuy, PhD; Phone Number: 4345 514-374-1480; Email: emma.dupuy@umontreal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Multidomain intervention; The multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month.	Other: Physical exercise training; 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.; Other: Cognitive training; 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.
EXPERIMENTAL: Physical exercise intervention; The physical exercises intervention will include the remote monitoring of physical exercise training for 6-month.	Other: Physical exercise training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Walking speed	4-meter walking test (m/s).	Baseline and post-intervention at 6 months.
Change in Functional mobility	Timed up and Go test (s).	Baseline and post-intervention at 6 months.
Change in Balance performance	Timed one-leg standing test (s).	Baseline and post-intervention at 6 months.
Change in Lower limb muscles strength	Timed Sit-to-Stand test (s).	Baseline and post-intervention at 6 months.
Change in Cardiorespiratory fitness	Matthews cardiorespiratory fitness questionnaire (the score is an estimation of individual VO2 max (ml.kg.min) and range from 15-50, with a higher score indicating a higher VO2max).	Baseline and post-intervention at 6 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality-of-life	36-Item Short Form Health Survey (Scale ranges from 0-100, with a higher score indicating a better health status).	Baseline and post-intervention at 6 months.
Change in Depressive symptomatology	Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology).	Baseline and post-intervention at 6 months.
Change in Anxiety	State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety).	Baseline and post-intervention at 6 months.
Change in Perceived stress	Perceived Stress Scale questionnaire (Score ranges from 0-4, with 0 no stress,1 mild stress, 3 moderate stress and 4 severe).	Baseline and post-intervention at 6 months.
Change in Repetitive negative thinking	Perseverative thinking questionnaire (Score ranges from 0-60, with a higher score indicating more repetitive negative thinking).	Baseline and post-intervention at 6 months.
Change in Self-perceived resilience	Connor-Davidson Resilience Scale 10 questionnaire (Score ranges from 0-40, with a higher indicating better the resilience).	Baseline and post-intervention at 6 months.
Change in Perceived social support	Lubben Social Network Scale questionnaire (Score ranges from 0-30, with a higher score indicating more social engagement).	Baseline and post-intervention at 6 months.
Change in Social and community activities involvement	Social and community involvement questionnaire (Score ranges from 0-200, with a higher score indicating more social and community involvement).	Baseline and post-intervention at 6 months.
Change in Self-reported physical activity	Physical Activity Scale for the Elderly questionnaire (Score ranges from 0-400, with a higher score indicating better level of physical activity).	Baseline and post-intervention at 6 months.
Change in Sleep quality	Pittsburg Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality).	Baseline and post-intervention at 6 months.
Change in Risk of sleep apnea	Berlin Questionnaire (Participants are classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories.High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive).	Baseline and post-intervention at 6 months.
Dietary patterns	Short Diet Questionnaire (Score ranges from 15-45 points, with a score between 15-29 categorised as unhealthy, 30-37 as somewhat unhealthy, and 38 or more as a healthy diet).	Baseline.
Intolerance of Uncertainty	Intolerance of Uncertainty scale questionnaire (Score ranges from 27-135, with a higher score indicating higher intolerance of uncertainty).	Baseline.
Anxiety Sensitivity	Anxiety Sensitivity Index questionnaire (Score ranges from 0-64, with a higher score indicating a higher sensitivity to anxiety).	Baseline.
Perceived vulnerability to disease	Perceived vulnerability to disease questionnaire (Score ranges from 15-95, with a higher score indicating a higher perceived vulnerability to disease).	Baseline.
Cognitive Reserve	Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve).	Baseline.
Self-reported masculinity and femininity traits	Short Form Bem Sex-Role Inventory questionnaire (30 items questionnaire with 10 items assessing the femininity traits, 10 items assessing the masculinity traits, and 10 items neutral, not scored. Two scores are calculated for femininity and masculinity, respectively, and range from 10-70, whit a higher score indicating a higher femininity or masculinity trait).	Baseline.

Collaborators and Investigators

• Sponsor: Louis Bherer

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 18, 2020
• Primary Completion (ANTICIPATED): October 15, 2021
• Study Completion (ANTICIPATED): May 18, 2022

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (ACTUAL): November 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Aging; Cognition; Cognitive Training; Remote monitoring; Physical Exercise; Home-based training
• Other Study ID Numbers: 2020-2785

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No