Clinical trial NCT04356248: Training and Energy Management Education to Improve Quality of Life in Persons With Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Klinik Valens
Sponsor class: OTHER
Collaborators: name: German Sport University, Cologne
name: University of Applied Sciences and Arts of Southern Switzerland
First posted: 2020-04-22
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Short-form 36 (SF-36)
timeFrame: 6 months (day 0 - day 183) with time points set after three weeks (day 21) and 4 months (day 122).
Secondary outcomes:
measure: Indicators of inflammatory activity
timeFrame: Three weeks (day 0 - day 21).
measure: Cardiorespiratory Fitness
timeFrame: Three weeks (day 0 - day 21).
measure: Self-efficacy in performing energy conservation strategies (SEPECSA)
timeFrame: Six months (day 0 - day 183) with time points set after three weeks (day 21) and after 4 months (day 122).
measure: Self-perceived competence in activities of daily living (OSA)
timeFrame: Six months (day 0 - day 21) with time points set after three weeks (day 21) and four months (day 122).
measure: Fatigue Scale of motor and cognitive function (FSMC)
timeFrame: Six months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122).
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122).
Other outcomes:
Locations:
city: Valens
country: Switzerland
facility: Kliniken-Valens
state: Sankt Gallen
Study officials:
affiliation: Klinik Valens
name: Jens Bansi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.