Training and Energy Management Education to Improve Quality of Life in
High Intensity Training and Energy Management Education vs. Standard Training and Muscle Relaxation, to Improve Quality of Life in Persons With Multiple Sclerosis, a Randomized Controlled Superiority Trial With Six Months' Follow-up
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Endurance Training
- Education
What it measured
Main measures
Short-form 36 (SF-36)
6 months (day 0 - day 183) with time points set after three weeks (day 21) and 4 months (day 122).
Quality of life (reported by participants)
Other measures (6)
Indicators of inflammatory activity
Three weeks (day 0 - day 21).
Physical functionImmune responseCardiorespiratory Fitness
Three weeks (day 0 - day 21).
Physical functionSelf-efficacy in performing energy conservation strategies (SEPECSA)
Six months (day 0 - day 183) with time points set after three weeks (day 21) and after 4 months (day 122).
Self-perceived competence in activities of daily living (OSA)
Six months (day 0 - day 21) with time points set after three weeks (day 21) and four months (day 122).
Fatigue Scale of motor and cognitive function (FSMC)
Six months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122).
Thinking and memoryFatigueHospital Anxiety and Depression Scale (HADS)
6 months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122).
Mood and sleep
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Definite MS diagnosis (revised McDonald criteria, 2018). * Age >18y * Expanded Disability Status Scale (EDSS) score ≤ 6.5 * Fatigue Scale of Motor and Cognitive function (FSMC) total score > 43 * Literacy and understanding German * Informed Consent
Exclusion criteria
* Women who are pregnant or breastfeeding / have the intention to become pregnant during the course of the study * Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) * Known or suspected non-compliance, drug or alcohol abuse * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Enrolment of the investigator, his/her family members, employees and other dependent persons * Cognitive impairment Mini-Mental State Examination (MMSE) \< 21 * Major Depression or Hospital Anxiety and Depression Scale (HADS) >11 at baseline * Stem cell treatment in the last 6 months * Participation in a previous high-intensity interval training (HIIT) or inpatient energy management education (IEME) study
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Persons with Multiple Sclerosis (PwMS) often suffer from impaired mobility and reduced aerobic capacity. Moreover, 65% of PwMS recognize fatigue as their most disabling symptom that quickly impacts patients' health-related quality of life (QoL). Systematic reviews that evaluate therapeutic options for MS-neurorehabilitation show good evidence for exercise and energy management/conservation programs to improve fatigue or its impact on daily life. Guidelines recommend a multidisciplinary approach but to date only unimodal interventions are investigated. This study aims to investigate the influence of the combination of two different therapeutic concepts: inpatient energy management education (IEME) + High-intensity interval training (HIIT). This intervention is compared with a control group that undergoes progressive muscle relaxation (PMR) + low-intensity training (ST). IEME or PMR is performed on two days (tue-thur) and HIIT or ST on three days (mo-wed-fr) / week. The primary outcome is the effect on the quality of life after three weeks rehabilitation and after returning home (at 4 and 6 months follow-up) in PwMS.
Papers
Results
Vitamin B<sub>6</sub> status is related to disease severity and modulated by endurance exercise in individuals with multiple sclerosis: a secondary analysis of a randomized controlled trial.Am J Clin Nutr · 2025
Results
Predictors of six-month change in health-related quality of life in people with multiple sclerosis: A secondary data analysis of a randomized controlled trial.Mult Scler Relat Disord · 2024
Results
The serum kynurenine pathway metabolic profile is associated with overweight and obesity in multiple sclerosis.Mult Scler Relat Disord · 2023
Results
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 monthsBMC Neurol · 2021
Results
Kupjetz M, Langeskov-Christensen M, Riemenschneider M, Inerle S, Ligges U, Gaemelke T, Patt N, Bansi J, Gonzenbach RR, Reuter M, Rosenberger F, Meyer T, McCann A, Ueland PM, Eskildsen SF, Nygaard MKE, Joisten N, Hvid L, Dalgas U, Zimmer P. Persons With Multiple Sclerosis Reveal Distinct Kynurenine Pathway Metabolite Patterns: A Multinational Cross-Sectional Study. Neurol Neuroimmunol Neuroinflamm.Results
Kupjetz M, Patt N, Joisten N, Ueland PM, McCann A, Gonzenbach R, Bansi J, Zimmer P. Baseline Inflammation but not Exercise Modality Impacts Exercise-induced Kynurenine Pathway Modulation in Persons With Multiple Sclerosis: Secondary Results From a Randomized Controlled Trial. Int J Tryptophan Res. 2024 Nov 11;17:11786469241284423. doi: 10.1177/11786469241284423. eCollection 2024.
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History
Started
Jul 2020
Main results due
May 2022
Finished
May 2022