Study protocol: Improving cognition in people with progressive multiple sclerosis: A multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx)

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Study protocol : Improving cognition in people with progressive multiple sclerosis: A multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx). / Feinstein, Anthony; Amato, Maria Pia; Brichetto, Giampaolo; Chataway, Jeremy; Chiaravalloti, Nancy; Dalgas, Ulrik; Deluca, John; Feys, Peter; Filippi, Massimo; Freeman, Jennifer; Meza, Cecilia; Inglese, Matilde; Motl, Robert W.; Rocca, Maria Assunta; Sandroff, Brian M.; Salter, Amber; Cutter, Gary; CogEx Research Team.

I: BMC Neurology, Bind 20, Nr. 1, 204, 2020.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

Harvard

Feinstein, A, Amato, MP, Brichetto, G, Chataway, J, Chiaravalloti, N, Dalgas, U, Deluca, J, Feys, P, Filippi, M, Freeman, J, Meza, C, Inglese, M, Motl, RW, Rocca, MA, Sandroff, BM, Salter, A, Cutter, G & CogEx Research Team 2020, 'Study protocol: Improving cognition in people with progressive multiple sclerosis: A multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx)', BMC Neurology, bind 20, nr. 1, 204. https://doi.org/10.1186/s12883-020-01772-7

APA

Feinstein, A., Amato, M. P., Brichetto, G., Chataway, J., Chiaravalloti, N., Dalgas, U., Deluca, J., Feys, P., Filippi, M., Freeman, J., Meza, C., Inglese, M., Motl, R. W., Rocca, M. A., Sandroff, B. M., Salter, A., Cutter, G., & CogEx Research Team (2020). Study protocol: Improving cognition in people with progressive multiple sclerosis: A multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx). BMC Neurology, 20(1), [204]. https://doi.org/10.1186/s12883-020-01772-7

CBE

Feinstein A, Amato MP, Brichetto G, Chataway J, Chiaravalloti N, Dalgas U, Deluca J, Feys P, Filippi M, Freeman J, Meza C, Inglese M, Motl RW, Rocca MA, Sandroff BM, Salter A, Cutter G, CogEx Research Team. 2020. Study protocol: Improving cognition in people with progressive multiple sclerosis: A multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx). BMC Neurology. 20(1):Article 204. https://doi.org/10.1186/s12883-020-01772-7

MLA

Vancouver

Author

Feinstein, Anthony ; Amato, Maria Pia ; Brichetto, Giampaolo ; Chataway, Jeremy ; Chiaravalloti, Nancy ; Dalgas, Ulrik ; Deluca, John ; Feys, Peter ; Filippi, Massimo ; Freeman, Jennifer ; Meza, Cecilia ; Inglese, Matilde ; Motl, Robert W. ; Rocca, Maria Assunta ; Sandroff, Brian M. ; Salter, Amber ; Cutter, Gary ; CogEx Research Team. / Study protocol : Improving cognition in people with progressive multiple sclerosis: A multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx). I: BMC Neurology. 2020 ; Bind 20, Nr. 1.

Bibtex

@article{1f5ccd8e2e874b33a396851600faafa2,
title = "Study protocol: Improving cognition in people with progressive multiple sclerosis: A multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx)",
abstract = "Background: Cognitive dysfunction affects up to 70% of people with progressive MS (PMS). It can exert a deleterious effect on activities of daily living, employment and relationships. Preliminary evidence suggests that performance can improve with cognitive rehabilitation (CR) and aerobic exercise (EX), but existing data are predominantly from people with relapsing-remitting MS without cognitive impairment. There is therefore a need to investigate whether this is also the case in people with progressive forms of the disease who have objectively identified cognitive impairment. It is hypothesized that CR and EX are effective treatments for people with PMS who have cognitive impairment, in particular processing speed (PS) deficits, and that a combination of these two treatments is more effective than each individual treatment given alone. We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques. Methods: This study is a multisite, randomized, double-blinded, sham controlled clinical trial of CR and aerobic exercise. Three hundred and sixty subjects from 11 sites will be randomly assigned into one of four groups: CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise. Subjects will participate in the assigned treatments for 12 weeks, twice a week. All subjects will have a cognitive and physical assessment at baseline, 12 weeks and 24 weeks. In an embedded sub-study, approximately 30% of subjects will undergo structural and functional MRI to investigate the neural mechanisms underlying the behavioral response. The primary outcome is the Symbol Digit Modalities Test (SDMT) measuring PS. Secondary outcome measures include: indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI. Discussion: The study is being undertaken in 6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages. The rationale for this approach is to obtain a robustly powered sample size and to demonstrate that these two interventions can be given effectively in multiple countries and in different languages. Trial registration: The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated.",
keywords = "Aerobic exercise, Cognitive training, Progressive multiple sclerosis",
author = "Anthony Feinstein and Amato, {Maria Pia} and Giampaolo Brichetto and Jeremy Chataway and Nancy Chiaravalloti and Ulrik Dalgas and John Deluca and Peter Feys and Massimo Filippi and Jennifer Freeman and Cecilia Meza and Matilde Inglese and Motl, {Robert W.} and Rocca, {Maria Assunta} and Sandroff, {Brian M.} and Amber Salter and Gary Cutter and {CogEx Research Team}",
year = "2020",
doi = "10.1186/s12883-020-01772-7",
language = "English",
volume = "20",
journal = "B M C Neurology",
issn = "1471-2377",
publisher = "BioMed Central Ltd.",
number = "1",

}

RIS

TY - JOUR

T1 - Study protocol

T2 - Improving cognition in people with progressive multiple sclerosis: A multi-arm, randomized, blinded, sham-controlled trial of cognitive rehabilitation and aerobic exercise (COGEx)

AU - Feinstein, Anthony

AU - Amato, Maria Pia

AU - Brichetto, Giampaolo

AU - Chataway, Jeremy

AU - Chiaravalloti, Nancy

AU - Dalgas, Ulrik

AU - Deluca, John

AU - Feys, Peter

AU - Filippi, Massimo

AU - Freeman, Jennifer

AU - Meza, Cecilia

AU - Inglese, Matilde

AU - Motl, Robert W.

AU - Rocca, Maria Assunta

AU - Sandroff, Brian M.

AU - Salter, Amber

AU - Cutter, Gary

AU - CogEx Research Team

PY - 2020

Y1 - 2020

N2 - Background: Cognitive dysfunction affects up to 70% of people with progressive MS (PMS). It can exert a deleterious effect on activities of daily living, employment and relationships. Preliminary evidence suggests that performance can improve with cognitive rehabilitation (CR) and aerobic exercise (EX), but existing data are predominantly from people with relapsing-remitting MS without cognitive impairment. There is therefore a need to investigate whether this is also the case in people with progressive forms of the disease who have objectively identified cognitive impairment. It is hypothesized that CR and EX are effective treatments for people with PMS who have cognitive impairment, in particular processing speed (PS) deficits, and that a combination of these two treatments is more effective than each individual treatment given alone. We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques. Methods: This study is a multisite, randomized, double-blinded, sham controlled clinical trial of CR and aerobic exercise. Three hundred and sixty subjects from 11 sites will be randomly assigned into one of four groups: CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise. Subjects will participate in the assigned treatments for 12 weeks, twice a week. All subjects will have a cognitive and physical assessment at baseline, 12 weeks and 24 weeks. In an embedded sub-study, approximately 30% of subjects will undergo structural and functional MRI to investigate the neural mechanisms underlying the behavioral response. The primary outcome is the Symbol Digit Modalities Test (SDMT) measuring PS. Secondary outcome measures include: indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI. Discussion: The study is being undertaken in 6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages. The rationale for this approach is to obtain a robustly powered sample size and to demonstrate that these two interventions can be given effectively in multiple countries and in different languages. Trial registration: The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated.

AB - Background: Cognitive dysfunction affects up to 70% of people with progressive MS (PMS). It can exert a deleterious effect on activities of daily living, employment and relationships. Preliminary evidence suggests that performance can improve with cognitive rehabilitation (CR) and aerobic exercise (EX), but existing data are predominantly from people with relapsing-remitting MS without cognitive impairment. There is therefore a need to investigate whether this is also the case in people with progressive forms of the disease who have objectively identified cognitive impairment. It is hypothesized that CR and EX are effective treatments for people with PMS who have cognitive impairment, in particular processing speed (PS) deficits, and that a combination of these two treatments is more effective than each individual treatment given alone. We further hypothesize that improvements in PS will be associated with modifications of functional and/or structural plasticity within specific brain networks/regions involved in PS measured with advanced MRI techniques. Methods: This study is a multisite, randomized, double-blinded, sham controlled clinical trial of CR and aerobic exercise. Three hundred and sixty subjects from 11 sites will be randomly assigned into one of four groups: CR plus aerobic exercise; CR plus sham exercise; CR sham plus aerobic exercise and CR sham plus sham exercise. Subjects will participate in the assigned treatments for 12 weeks, twice a week. All subjects will have a cognitive and physical assessment at baseline, 12 weeks and 24 weeks. In an embedded sub-study, approximately 30% of subjects will undergo structural and functional MRI to investigate the neural mechanisms underlying the behavioral response. The primary outcome is the Symbol Digit Modalities Test (SDMT) measuring PS. Secondary outcome measures include: indices of verbal and non-verbal memory, depression, walking speed and a dual cognitive-motor task and MRI. Discussion: The study is being undertaken in 6 countries (11 centres) in multiple languages (English, Italian, Danish, Dutch); with testing material validated and standardized in these languages. The rationale for this approach is to obtain a robustly powered sample size and to demonstrate that these two interventions can be given effectively in multiple countries and in different languages. Trial registration: The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated.

KW - Aerobic exercise

KW - Cognitive training

KW - Progressive multiple sclerosis

UR - http://www.scopus.com/inward/record.url?scp=85085264690&partnerID=8YFLogxK

U2 - 10.1186/s12883-020-01772-7

DO - 10.1186/s12883-020-01772-7

M3 - Journal article

C2 - 32443981

AN - SCOPUS:85085264690

VL - 20

JO - B M C Neurology

JF - B M C Neurology

SN - 1471-2377

IS - 1

M1 - 204

ER -