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| Name | Class |
|---|---|
| German Sport University, Cologne | OTHER |
| University of Applied Sciences and Arts of Southern Switzerland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-intensity interval training + energy management education | Experimental |
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| Low-intensity training + progressive muscle relaxation | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endurance Training | Behavioral | Treatment in both arms consists of specific endurance exercise modalities (HIIT or ST). Treatments differ in the applied training intensities. Participants in both arms will exercise 3 times per week over a period of 3 weeks on a bicycle ergometer. Exercise sessions will be supervised by a trained physical therapist. Exercise intensity will be heart rate monitored based on the maximum heart rate (HRmax) assessed during the initial cardiopulmonary exercise test. Exercise sessions in both arms will include a warm-up and a cool-down period at low intensity (50% HRmax) for 3 min each. |
| Measure | Description | Time Frame |
|---|---|---|
| Short-form 36 (SF-36) | Changes of health-related quality of life will be assessed with the SF-36. The SF-36 questionnaire comprises 36 items. Scores range from 0 to 100 with higher values indicating better QoL. | 6 months (day 0 - day 183) with time points set after three weeks (day 21) and 4 months (day 122). |
| Measure | Description | Time Frame |
|---|---|---|
| Indicators of inflammatory activity | Soluble factors that are known to be produced or secreted in response to exercise and are suspected to modify immune homeostasis and blood brain barrier function through their inflammatory and anti-inflammatory properties. Changes of Matrix-metalloproteinases-2 (MMP-2), Tryptophan, Kynurenine, Kynurenine acid, Interferon-gamma (IFN-Gamma) and Interleukin-6 (IL-6) will be assessed. Higher values indicate higher levels of Inflammation. |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Bansi, PhD | Klinik Valens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniken-Valens | Valens | Canton of St. Gallen | 7317 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40966534 | Derived | 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. 2025 Nov;12(6):e200461. doi: 10.1212/NXI.0000000000200461. Epub 2025 Sep 18. | |
| 40252731 |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000076663 | Endurance Training |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Education | Behavioral | Treatment in both arms consists of specific energy management education interventions (IEME or PMR). Treatments differ in the applied education approaches. Participants in both arms will exercise 2 times per week over a period of 3 weeks. |
|
| Three weeks (day 0 - day 21). |
| Cardiorespiratory Fitness | Changes of cardiorespiratory fitness will be measured by peak oxygen consumption achieved in the cardiopulmonary exercise test. Higher values indicate better cardiorespiratory fitness. | Three weeks (day 0 - day 21). |
| Self-efficacy in performing energy conservation strategies (SEPECSA) | Changes of self-efficacy in performing energy conservation strategies will be assessed with a self-reported questionnaire. The questionnaire consists of 14 items. The participants are asked to rank how confident they are that they can perform each item on a scale from 1 (= not at all confident/sure) to 10 (= completely confident/sure). The final score is found by adding the total items' score and dividing it by 14, with higher scores indicating greater confidence in self-efficacy. | 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) | Changes of self-perceived competence are assessed with a self reported questionnaire. The questionnaire consists of 21 items that represent participation in habits and roles, performance of skills, and volition for participation. Participants rate each item with two 4-point likert scales to indicate their self-perception of occupational competence (I have a lot of problems doing this - I have some difficulty doing this - I do this well - I do this extremely well) and value for importance (This is not so important to me - This is important to me - This is more important to me - This is most important to me). Following these two steps, clients review their ratings and choose areas of occupational performance and participation that they would like to change. Higher scores indicate better competences. | 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) | Changes of motor and cognitive fatigue are assessed on a 5-point likert-scale. Max 50 Points for subscales, 100 Points for the Total score. Cut-off for fatigue is set for the total score at 43 and for the motoric and cognitive subscores at 22 with higher values participants being more fatigued. | Six months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122). |
| Hospital Anxiety and Depression Scale (HADS) | Changes of anxiety and depression over three weeks training on a 4-point likert scale scored 0-3. Max 21 Points for each subscale, cut off for anxiety and Depression are set at 7 Points higher values represent more anxiety and Depression. | 6 months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122). |
| Derived |
| Belen S, Patt N, Kupjetz M, Ueland PM, McCann A, Gonzenbach R, Bansi J, Zimmer P. Vitamin B6 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 Jun;121(6):1403-1414. doi: 10.1016/j.ajcnut.2025.04.014. Epub 2025 Apr 17. |
| 39534856 | Derived | 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. |
| 36881945 | Derived | Kupjetz M, Patt N, Joisten N, Ueland PM, McCann A, Gonzenbach R, Bansi J, Zimmer P. The serum kynurenine pathway metabolic profile is associated with overweight and obesity in multiple sclerosis. Mult Scler Relat Disord. 2023 Apr;72:104592. doi: 10.1016/j.msard.2023.104592. Epub 2023 Mar 1. |
| 33573608 | Derived | Patt N, Kool J, Hersche R, Oberste M, Walzik D, Joisten N, Caminada D, Ferrara F, Gonzenbach R, Nigg CR, Kamm CP, Zimmer P, Bansi J. 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. BMC Neurol. 2021 Feb 11;21(1):65. doi: 10.1186/s12883-021-02084-0. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |