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

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT04356248
• Lead Sponsor: Klinik Valens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-22
• Study Start: 2020-07-13
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).	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.

Secondary Outcome Measures

Name	Time	Method
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).	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.
Hospital 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).	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.
Indicators of inflammatory activity	Three weeks (day 0 - day 21).	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.
Cardiorespiratory Fitness	Three weeks (day 0 - day 21).	Changes of cardiorespiratory fitness will be measured by peak oxygen consumption achieved in the cardiopulmonary exercise test. Higher values indicate better cardiorespiratory fitness.
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).	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.
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).	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.

Trial Locations

Locations (1)

Kliniken-Valens; 🇨🇭 Valens, Sankt Gallen, Switzerland