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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Endurance Training
Education
Sponsored by
Klinik Valens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kliniken-Valens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity interval training + energy management education

Low-intensity training + progressive muscle relaxation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 14, 2020
Last Updated
June 9, 2022
Sponsor
Klinik Valens
Collaborators
German Sport University, Cologne, University of Applied Sciences and Arts of Southern Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04356248
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
May 11, 2022 (Actual)
Study Completion Date
May 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinik Valens
Collaborators
German Sport University, Cologne, University of Applied Sciences and Arts of Southern Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training + energy management education
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-intensity training + progressive muscle relaxation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Endurance Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Short-form 36 (SF-36)
Description
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.
Time Frame
6 months (day 0 - day 183) with time points set after three weeks (day 21) and 4 months (day 122).
Secondary Outcome Measure Information:
Title
Indicators of inflammatory activity
Description
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.
Time Frame
Three weeks (day 0 - day 21).
Title
Cardiorespiratory Fitness
Description
Changes of cardiorespiratory fitness will be measured by peak oxygen consumption achieved in the cardiopulmonary exercise test. Higher values indicate better cardiorespiratory fitness.
Time Frame
Three weeks (day 0 - day 21).
Title
Self-efficacy in performing energy conservation strategies (SEPECSA)
Description
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.
Time Frame
Six months (day 0 - day 183) with time points set after three weeks (day 21) and after 4 months (day 122).
Title
Self-perceived competence in activities of daily living (OSA)
Description
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.
Time Frame
Six months (day 0 - day 21) with time points set after three weeks (day 21) and four months (day 122).
Title
Fatigue Scale of motor and cognitive function (FSMC)
Description
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.
Time Frame
Six months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122).
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
6 months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Bansi, PhD
Organizational Affiliation
Klinik Valens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kliniken-Valens
City
Valens
State/Province
Sankt Gallen
ZIP/Postal Code
7317
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33573608
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.
Results Reference
derived

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

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