High-intensity interval training and energy management education, compared with moderate continuous training and progressive muscle relaxation, for improving health-related quality of life in persons with multiple sclerosis: study protocol of a randomized controlled superiority trial with six months' follow-up.
Energy management education
Exercise
Fatigue
High-intensity interval training
Inflammation
Multidisciplinary rehabilitation
Multiple sclerosis
Occupational therapy
Quality of life
Journal
BMC neurology
ISSN: 1471-2377
Titre abrégé: BMC Neurol
Pays: England
ID NLM: 100968555
Informations de publication
Date de publication:
11 Feb 2021
11 Feb 2021
Historique:
received:
06
01
2021
accepted:
28
01
2021
entrez:
12
2
2021
pubmed:
13
2
2021
medline:
28
4
2021
Statut:
epublish
Résumé
Persons with multiple sclerosis (PwMS) often have reduced aerobic capacity and report fatigue as the most disabling symptom impacting their health-related quality of life (HRQoL). A multidisciplinary rehabilitation approach is recommended for successful management of symptoms, although there is little supporting evidence. The aim of this study is to evaluate the effect of a multimodal therapy approach, including endurance training and patient education, during a three-week inpatient rehabilitation stay, on HRQoL in PwMS at six months follow-up. Inpatient energy management education (IEME) + high-intensity interval training (HIIT) will be compared with progressive muscle relaxation (PMR) + moderate continuous training (MCT). This study has a two-armed single-blind randomized controlled superiority trial design. One hundred six PwMS-related fatigue (relapsing-remitting or chronic progressive phenotypes; Expanded Disability Status Scale (EDSS) ≤ 6.5) will be recruited at the Valens clinic, Switzerland, and randomized into either an experimental (EG) or a control group (CG). EG: participants will perform IEME twice and HIIT three times per week during the three-week rehabilitation stay. IEME is a group-based intervention, lasting for 6.5 h over three weeks. HIIT contains of five 1.5-min high-intensive exercise bouts on a cycle ergometer at 95-100% of peak heart rate (HR This study will provide detailed information on a multimodal therapy approach to further improve rehabilitation for PwMS. This trial was prospectively registered at ClinicalTrials.gov ( NCT04356248 ; 22 April 2020).
Sections du résumé
BACKGROUND
BACKGROUND
Persons with multiple sclerosis (PwMS) often have reduced aerobic capacity and report fatigue as the most disabling symptom impacting their health-related quality of life (HRQoL). A multidisciplinary rehabilitation approach is recommended for successful management of symptoms, although there is little supporting evidence. The aim of this study is to evaluate the effect of a multimodal therapy approach, including endurance training and patient education, during a three-week inpatient rehabilitation stay, on HRQoL in PwMS at six months follow-up. Inpatient energy management education (IEME) + high-intensity interval training (HIIT) will be compared with progressive muscle relaxation (PMR) + moderate continuous training (MCT).
METHODS
METHODS
This study has a two-armed single-blind randomized controlled superiority trial design. One hundred six PwMS-related fatigue (relapsing-remitting or chronic progressive phenotypes; Expanded Disability Status Scale (EDSS) ≤ 6.5) will be recruited at the Valens clinic, Switzerland, and randomized into either an experimental (EG) or a control group (CG). EG: participants will perform IEME twice and HIIT three times per week during the three-week rehabilitation stay. IEME is a group-based intervention, lasting for 6.5 h over three weeks. HIIT contains of five 1.5-min high-intensive exercise bouts on a cycle ergometer at 95-100% of peak heart rate (HR
DISCUSSION
CONCLUSIONS
This study will provide detailed information on a multimodal therapy approach to further improve rehabilitation for PwMS.
TRIAL REGISTRATION
BACKGROUND
This trial was prospectively registered at ClinicalTrials.gov ( NCT04356248 ; 22 April 2020).
Identifiants
pubmed: 33573608
doi: 10.1186/s12883-021-02084-0
pii: 10.1186/s12883-021-02084-0
pmc: PMC7877079
doi:
Banques de données
ClinicalTrials.gov
['NCT04356248']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
65Références
J Clin Epidemiol. 2007 Dec;60(12):1234-8
pubmed: 17998077
Clin Rehabil. 2005 Aug;19(5):538-43
pubmed: 16119410
Am J Occup Ther. 2007 Jan-Feb;61(1):62-9
pubmed: 17302106
Arch Phys Med Rehabil. 2017 Feb;98(2):353-367
pubmed: 27216225
Mult Scler Relat Disord. 2018 Aug;24:55-63
pubmed: 29936326
Disabil Rehabil. 2013 Mar;35(5):353-61
pubmed: 23347461
Fam Community Health. 2007 Apr-Jun;30(2):144-50
pubmed: 19241650
Neurology. 1983 Nov;33(11):1444-52
pubmed: 6685237
Acta Psychiatr Scand. 1983 Jun;67(6):361-70
pubmed: 6880820
Mult Scler. 2020 Sep 3;:1352458520951382
pubmed: 32880214
Lancet Neurol. 2005 Sep;4(9):556-66
pubmed: 16109362
Mult Scler. 2008 Jan;14(1):140-2
pubmed: 18089672
Behav Res Methods. 2007 May;39(2):175-91
pubmed: 17695343
Soz Praventivmed. 2005;50(5):292-300
pubmed: 16300173
Mult Scler. 2009 Dec;15(12):1509-17
pubmed: 19995840
EPMA J. 2016 Nov 24;7:25
pubmed: 27904656
Mult Scler. 2018 Oct;24(12):1635-1644
pubmed: 28825348
Fam Community Health. 2004 Jan-Mar;27(1):75-85
pubmed: 14724504
Arch Neurol. 1988 Apr;45(4):435-7
pubmed: 3355400
Can J Appl Sport Sci. 1985 Sep;10(3):141-6
pubmed: 4053261
Lancet Neurol. 2018 Feb;17(2):162-173
pubmed: 29275977
Occup Ther Int. 2005;12(4):234-49
pubmed: 16485510
Lancet. 2008 Oct 25;372(9648):1502-17
pubmed: 18970977
Sports Med. 2015 Jun;45(6):905-23
pubmed: 25739555
Health Policy. 1996 Jul;37(1):53-72
pubmed: 10158943
Mult Scler. 2013 Oct;19(12):1647-54
pubmed: 23652213
PLoS One. 2015 Feb 18;10(2):e0115541
pubmed: 25692993
Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3
pubmed: 23669008
Mult Scler Int. 2014;2014:798285
pubmed: 24963407
Int J MS Care. 2019 Nov-Dec;21(6):265-274
pubmed: 31889931
J Neurol Sci. 2017 Oct 15;381:41-54
pubmed: 28991714
Curr Neurol Neurosci Rep. 2019 Nov 13;19(11):88
pubmed: 31720862
Mult Scler. 2006 Aug;12(4):367-8
pubmed: 16900749
Med Care. 1992 Jun;30(6):473-83
pubmed: 1593914
Int J MS Care. 2015 Sep-Oct;17(5):245-52
pubmed: 26472946
Control Clin Trials. 2002 Dec;23(6):662-74
pubmed: 12505244
Int J MS Care. 2016 May-Jun;18(3):129-37
pubmed: 27252600
J Clin Nurs. 2009 Aug;18(15):2171-9
pubmed: 19583649
Mult Scler Relat Disord. 2019 Oct;35:26-33
pubmed: 31280074
Exerc Immunol Rev. 2020;26:24-42
pubmed: 32139353
Lancet Neurol. 2005 Oct;4(10):643-52
pubmed: 16168933
J Geriatr Psychiatry Neurol. 2004 Jun;17(2):81-7
pubmed: 15157348