Dataset Information

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.

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 (HR_peak), followed by active breaks of unloaded pedalling for 2?min to achieve 60% of HR_peak. 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 HR_peak. 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).

SUBMITTER: Patt N

PROVIDER: S-EPMC7877079 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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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.

Patt Nadine N Kool Jan J Hersche Ruth R Oberste Max M Walzik David D Joisten Niklas N Caminada Daniel D Ferrara Francesca F Gonzenbach Roman R Nigg Claudio Renato CR Kamm Christian Philipp CP Zimmer Philipp P Bansi Jens J

BMC neurology 20210211 1

<h4>Background</h4>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 inp ...[more]

PMID: 33573608

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