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

NCT04356248 | Completed

• 1 other identifier: 2020-000769
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (6)

• Indicators of inflammatory activity

  Three weeks (day 0 - day 21).

• Cardiorespiratory Fitness

  Three weeks (day 0 - day 21).

• Self-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).

Study Arms (2)

High-intensity interval training + energy management education

EXPERIMENTAL

* High-intensity interval training (HIIT): physiologically defined heart rate-controlled cycling with 80-100 rounds per minute (rpm) at 95-100% of maximum heart rate (HRmax). Participants will perform 5 × 1.5-min high-intensive exercise bouts at 95-100% of their HRmax followed by active breaks of unloaded pedalling over 2 min with the aim to achieve 60% of HRmax. * Energy management education (IEME): face-to-face education sessions of 6.5 h in duration over a 3-week period, all conducted by a trained occupational therapist. Participants acquire knowledge and understanding about factors that influence energy and the consequences of fatigue on their habits and lifestyle. Six weeks after returning home, the participants will receive a reinforcement letter in the form of information material to remember the content of the IEME and to reinforce the implementation of the behaviour change in managing energy.

Behavioral: Endurance Training; Behavioral: Education

Low-intensity training + progressive muscle relaxation

ACTIVE COMPARATOR

* Low-intensity training (ST): participants will exercise for 24 min continuously at 65% of participants' HRmax (60-70 rpm). * Progressive muscle relaxation (PMR): The aim of PMR is to achieve enhanced mental relaxation by reducing muscle tension. Participants will attend six 1-h group sessions over the 3-week intervention period, instructed by a trained physical therapist. Six weeks after returning home, the participants will receive a reinforcement letter with information material for remembering the content of the PMR techniques and to reinforce the implementation of the exercises at home.

Behavioral: Endurance Training; Behavioral: Education

Interventions

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.

High-intensity interval training + energy management education; Low-intensity training + progressive muscle relaxation

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.

High-intensity interval training + energy management education; Low-intensity training + progressive muscle relaxation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinik Valens: lead
• German Sport University, Cologne: collaborator
• University of Applied Sciences and Arts of Southern Switzerland: collaborator

Study Sites (1)

Kliniken-Valens

Valens, Canton of St. Gallen, 7317, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 40966534 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.

  PMID: 40252731 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.

  PMID: 39534856 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.

  PMID: 36881945 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.

  PMID: 33573608 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Endurance Training; Educational Status

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Jens Bansi, PhD

  Klinik Valens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Research and Deveopment and Sport Scientist

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 22, 2020
• Study Start: July 13, 2020
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

CH (1)