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.

Affiliation

Patt N(1), Kool J(2), Hersche R(3), Oberste M(4), Walzik D(5), Joisten N(5), Caminada D(6), Ferrara F(6), Gonzenbach R(2), Nigg CR(7), Kamm CP(8)(9), Zimmer P(5), Bansi J(2).
Author information:
(1)Department of Neurology, Kliniken-Valens, Rehabilitationsklinik-Valens, Taminaplatz 1, 7317, Valens, Switzerland. [Email]
(2)Department of Neurology, Kliniken-Valens, Rehabilitationsklinik-Valens, Taminaplatz 1, 7317, Valens, Switzerland.
(3)Rehabilitation Research Laboratory 2rLab, Department of Business Economics, Health and Social Care, University of Applied Sciences and Arts of Southern Switzerland, Via Violino 11, 6928, Manno, Switzerland.
(4)Department of Molecular and Cellular Sports Medicine, Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.
(5)Department of Performance and Health
(Sports Medicine), Institute for Sport and Sport Science, Technical University Dortmund, Otto-Hahn-Straße 3, 44227, Dortmund, Germany.
(6)Labormedizinisches Zentrum Dr Risch, Lagerstrasse 30, 9470, Buchs, Switzerland.
(7)Health Science Department, Institute of Sport Science, University of Bern, Bremgartenstrasse 145, 3012, Bern, Switzerland.
(8)Neurocentre, Luzerner Kantonsspital, Spitalstrasse, 6000, Luzern, Switzerland.
(9)Department of Neurology, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.

Abstract

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: 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 (HRpeak), followed by active breaks of unloaded pedalling for 2 min to achieve 60% of HRpeak. CG: participants will perform PMR twice and MCT three times per week during the three-week rehabilitation stay, representing local usual care. PMR consists of six 1-h relaxation group sessions. MCT consists of 24-min continuous cycling at 65% of HRpeak. The primary outcome is HRQoL (Physical and Mental Component Summaries of the Medical Outcome Study 36-item Short Form Health Survey; SF-36), measured at entry to the clinic (baseline, T0), three weeks after T0 (T1) and at four (T2) and six (T3) months after T0. Secondary outcomes comprise cardiorespiratory fitness, inflammatory markers (measured at T0 and T1), fatigue, mood, self-efficacy, occupational performance, physical activity (measured at T0, T1, T2 and T3) and behaviour changes in energy management (measured at T2 and T3). DISCUSSION: This study will provide detailed information on a multimodal therapy approach to further improve rehabilitation for PwMS. TRIAL REGISTRATION: This trial was prospectively registered at ClinicalTrials.gov ( NCT04356248 ; 22 April 2020).