NCT04356248

Training and Energy Management Education to Improve Quality of Life in Persons With Multiple Sclerosis

Completed NA Last updated 10 June 2022

What this trial tests

NA trial testing Endurance Training in Multiple Sclerosis in 106 participants. Completed in 11 May 2022.

Timeline

13 July 2020

Primary endpoint
11 May 2022

11 May 2022

Quick facts

Lead sponsor	Klinik Valens
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	106
Start date	13 July 2020
Primary completion	11 May 2022
Estimated completion	11 May 2022
Sites	1 location across Switzerland

Drugs / interventions tested

• Endurance Training
• Education

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Klinik Valens

Who can join

18 and older, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The serum kynurenine pathway metabolic profile is associated with overweight and obesity in multiple sclerosis.
   Kupjetz M, Patt N, Joisten N, Ueland PM, et al · · 2023 · cited 8× · PMID 36881945 · DOI 10.1016/j.msard.2023.104592
2. 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 t
   Patt N, Kool J, Hersche R, Oberste M, et al · · 2021 · cited 7× · PMID 33573608 · DOI 10.1186/s12883-021-02084-0
3. Baseline Inflammation but not Exercise Modality Impacts Exercise-induced Kynurenine Pathway Modulation in Persons With Multiple Sclerosis: Secondary Results From a Randomized Controlled Trial.
   Kupjetz M, Patt N, Joisten N, Ueland PM, et al · · 2024 · cited 5× · PMID 39534856 · DOI 10.1177/11786469241284423
4. Persons With Multiple Sclerosis Reveal Distinct Kynurenine Pathway Metabolite Patterns: A Multinational Cross-Sectional Study.
   Kupjetz M, Langeskov-Christensen M, Riemenschneider M, Inerle S, et al · · 2025 · cited 2× · PMID 40966534 · DOI 10.1212/nxi.0000000000200461
5. 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.
   Belen S, Patt N, Kupjetz M, Ueland PM, et al · · 2025 · cited 1× · PMID 40252731 · DOI 10.1016/j.ajcnut.2025.04.014
6. 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.
   Patt N, Kupjetz M, Schlagheck ML, Hersche R, et al · · 2024 · PMID 39191095 · DOI 10.1016/j.msard.2024.105826