- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04356248
Training and Energy Management Education to Improve Quality of Life in Persons With Multiple Sclerosis
June 9, 2022 updated by: Jens Bansi, Klinik Valens
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sankt Gallen
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Valens, Sankt Gallen, Switzerland, 7317
- Kliniken-Valens
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High-intensity interval training + energy management education
|
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.
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.
|
ACTIVE_COMPARATOR: Low-intensity training + progressive muscle relaxation
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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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.
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6 months (day 0 - day 183) with time points set after three weeks (day 21) and 4 months (day 122).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Three weeks (day 0 - day 21).
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Cardiorespiratory Fitness
Time Frame: Three weeks (day 0 - day 21).
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Changes of cardiorespiratory fitness will be measured by peak oxygen consumption achieved in the cardiopulmonary exercise test.
Higher values indicate better cardiorespiratory fitness.
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Three weeks (day 0 - day 21).
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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).
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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.
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Six months (day 0 - day 183) with time points set after three weeks (day 21) and after 4 months (day 122).
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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.
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Six months (day 0 - day 21) with time points set after three weeks (day 21) and four months (day 122).
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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.
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Six months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122).
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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).
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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.
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6 months (day 0 - day 183) with time points set after three weeks (day 21) and four months (day 122).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 13, 2020
Primary Completion (ACTUAL)
May 11, 2022
Study Completion (ACTUAL)
May 11, 2022
Study Registration Dates
First Submitted
April 14, 2020
First Submitted That Met QC Criteria
April 17, 2020
First Posted (ACTUAL)
April 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 9, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-000769
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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