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

• ClinicalTrials.gov Identifier: NCT04356248
• Recruitment Status: Completed
• First Posted: April 22, 2020
• Last Update Posted: June 10, 2022
• Sponsor: Klinik Valens
• Collaborators: German Sport University, Cologne; University of Applied Sciences and Arts of Southern Switzerland
• Information provided by (Responsible Party): Jens Bansi, Klinik Valens

Tracking Information

• First Submitted Date: April 14, 2020
• First Posted Date: April 22, 2020
• Last Update Posted Date: June 10, 2022
• Actual Study Start Date: July 13, 2020
• Actual Primary Completion Date: May 11, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 17, 2020)

Short-form 36 (SF-36) [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 17, 2020)

• Indicators of inflammatory activity [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
• Fatigue Scale of motor and cognitive function (FSMC) [ Time Frame: 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) [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Multiple Sclerosis

Intervention

• Behavioral: Endurance Training
  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.
• Behavioral: Education
  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.

Study Arms

• Experimental: High-intensity interval training + energy management education
  • 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.
  Interventions:

  • Behavioral: Endurance Training
  • Behavioral: Education
• Active Comparator: Low-intensity training + progressive muscle relaxation
  • 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.
  Interventions:

  • Behavioral: Endurance Training
  • Behavioral: Education

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 17, 2020): 106
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 11, 2022
• Actual Primary Completion Date: May 11, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT04356248
• Other Study ID Numbers: 2020-000769
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jens Bansi, Klinik Valens
• Original Responsible Party: Same as current
• Current Study Sponsor: Klinik Valens
• Original Study Sponsor: Same as current

Collaborators

• German Sport University, Cologne
• University of Applied Sciences and Arts of Southern Switzerland

Investigators

• Principal Investigator: Jens Bansi, PhD; Klinik Valens

• PRS Account: Klinik Valens
• Verification Date: June 2022