The impact of the COVID-19 pandemic on an international rehabilitation study in MS: the CogEx experience.
COVID-19
Cognition
Exercise
International
Multiple sclerosis
Multisite
Neurorehabilitation
Journal
Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161
Informations de publication
Date de publication:
Apr 2022
Apr 2022
Historique:
received:
22
09
2021
accepted:
28
10
2021
revised:
27
10
2021
pubmed:
7
11
2021
medline:
25
3
2022
entrez:
6
11
2021
Statut:
ppublish
Résumé
Pandemic restrictions have led to changes in therapy plans and disrupted rehabilitation services for people with multiple sclerosis. CogEx is an international, multicentre MS dual-intervention (cognitive rehabilitation, aerobic exercise) randomized, controlled rehabilitation trial confined to people with progressive disease. The primary outcome is cognition (processing speed).There are 11 treatment sites in six countries with participants required to make 27 site visits over 12 weeks. Collectively, the large, in-person demands of the trial, and the varying international policies for the containment of COVID-19, might disproportionately impact the administration of CogEx. During the first lockdown, all centres closed on average for 82.9 (SD = 24.3) days. One site was required to lockdown on two further occasions. One site remained closed for 16 months. Ten staff (19.2%) were required to quarantine and eight staff (15.4%) tested positive for COVID. 10 of 264 (3.8%) participants acquired COVID-19. All survived. The mean duration of enrollment delay has been [236.7 (SD = 214.5) days]. Restarting participants whose interventions were interrupted by the pandemic meant recalculating the intervention prescriptions for these individuals. While the impact of the pandemic on CogEx has been considerable, all study sites are again open. Participants and staff have shown considerable flexibility and resilience in keeping a complex, international endeavour running. The future in general remains uncertain in the midst of a pandemic, but there is cautious optimism the study will be completed with sufficient sample size to robustly evaluate our hypothesis and provide meaningful results to the MS community on the impact of these interventions on people with progressive MS.Trial registration: The trial was registered on September 20th 2018 at www.clinicaltrials.gov having identifier NCT03679468. Registration was performed before recruitment was initiated.
Identifiants
pubmed: 34741240
doi: 10.1007/s00415-021-10881-3
pii: 10.1007/s00415-021-10881-3
pmc: PMC8570234
doi:
Banques de données
ClinicalTrials.gov
['NCT03679468']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1758-1763Subventions
Organisme : Multiple Sclerosis Scientific Research Foundation
ID : EGID3185
Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.
Références
J Neurol. 2020 Dec;267(12):3467-3475
pubmed: 32638107
Nat Rev Neurol. 2020 Jun;16(6):319-332
pubmed: 32372033
Ther Innov Regul Sci. 2020 Jul;54(4):723-724
pubmed: 32557317
Mult Scler. 2022 Jan;28(1):132-138
pubmed: 33764197
BMC Neurol. 2020 May 22;20(1):204
pubmed: 32443981
Lancet Neurol. 2015 Feb;14(2):194-207
pubmed: 25772898
Neurol Neuroimmunol Neuroinflamm. 2021 Sep 8;8(6):
pubmed: 34497100
Trials. 2021 Apr 16;22(1):286
pubmed: 33863342
Mult Scler. 2021 Jun;27(7):989-1001
pubmed: 33720795
Mult Scler. 2020 Sep;26(10):1163-1171
pubmed: 32772807
Mult Scler J Exp Transl Clin. 2021 Aug 26;7(3):20552173211038030
pubmed: 34471543
Mult Scler. 2012 Nov;18(11):1534-40
pubmed: 22917690