Study Results
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Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2022-09-01
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cognitive-motor training group
Cognitive training
For the cognitive treatment intervention the widely used cognitive training program RehaCom will be used. This is a computer-aided program with more than 30 modules focusing on different domains of cognition. RehaCom has shown improvements in verbal learning, visuospatial memory, information processing speed, attention, executive functions, depression, fatigue and quality of life in PwMS (PMID 31927200, 28116167, 19825502, 23192417). Patients will train on their home computer without direct therapist supervision, using three RehaCom modules that are focused on improving working memory. Both patients in the combined intervention and the cognitive intervention group will be doing a 45-minute computer session respectively one and two days per week for a total of 12 weeks.
Motor training
For the motor treatment intervention a patient-tailored aerobic training program will be used. Based on their baseline physical activity level patients can choose out of a number of aerobic activities of either mild, moderate or strenuous intensity, with a total training time of 90 minutes for the motor intervention group and 45 minutes for the combined intervention group, divided over at least two training sessions per week of at least 15 minutes per session. The training will be carried out individually at home, without therapist supervision. All physical activities will be logged using the sport watch equipped with a heart rate sensor and an accelerometer. Training intensity will be assessed using the patient's heart rate and the Rating of Perceived Exertion scale.
Cognitive training group
Cognitive training
For the cognitive treatment intervention the widely used cognitive training program RehaCom will be used. This is a computer-aided program with more than 30 modules focusing on different domains of cognition. RehaCom has shown improvements in verbal learning, visuospatial memory, information processing speed, attention, executive functions, depression, fatigue and quality of life in PwMS (PMID 31927200, 28116167, 19825502, 23192417). Patients will train on their home computer without direct therapist supervision, using three RehaCom modules that are focused on improving working memory. Both patients in the combined intervention and the cognitive intervention group will be doing a 45-minute computer session respectively one and two days per week for a total of 12 weeks.
Motor training group
Motor training
For the motor treatment intervention a patient-tailored aerobic training program will be used. Based on their baseline physical activity level patients can choose out of a number of aerobic activities of either mild, moderate or strenuous intensity, with a total training time of 90 minutes for the motor intervention group and 45 minutes for the combined intervention group, divided over at least two training sessions per week of at least 15 minutes per session. The training will be carried out individually at home, without therapist supervision. All physical activities will be logged using the sport watch equipped with a heart rate sensor and an accelerometer. Training intensity will be assessed using the patient's heart rate and the Rating of Perceived Exertion scale.
Interventions
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Cognitive training
For the cognitive treatment intervention the widely used cognitive training program RehaCom will be used. This is a computer-aided program with more than 30 modules focusing on different domains of cognition. RehaCom has shown improvements in verbal learning, visuospatial memory, information processing speed, attention, executive functions, depression, fatigue and quality of life in PwMS (PMID 31927200, 28116167, 19825502, 23192417). Patients will train on their home computer without direct therapist supervision, using three RehaCom modules that are focused on improving working memory. Both patients in the combined intervention and the cognitive intervention group will be doing a 45-minute computer session respectively one and two days per week for a total of 12 weeks.
Motor training
For the motor treatment intervention a patient-tailored aerobic training program will be used. Based on their baseline physical activity level patients can choose out of a number of aerobic activities of either mild, moderate or strenuous intensity, with a total training time of 90 minutes for the motor intervention group and 45 minutes for the combined intervention group, divided over at least two training sessions per week of at least 15 minutes per session. The training will be carried out individually at home, without therapist supervision. All physical activities will be logged using the sport watch equipped with a heart rate sensor and an accelerometer. Training intensity will be assessed using the patient's heart rate and the Rating of Perceived Exertion scale.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expanded Disability Status Scale (EDSS) below 6.0
* Digit span backwards z-score between \[-3 and -0.5\] standard deviations below the median of the normative values
* Age between 18 and 65
* Able to safely perform motor rehabilitation in the home situation (assessed by rehabilitation physician and/or occupational or physiotherapist)
Exclusion Criteria
* Inpatient multidisciplinary rehabilitation program within three months before inclusion or planned inpatient program during trial
* Start of or switch in immunomodulator treatment within three months before inclusion
* Less than one month post-exacerbation
* Major psychiatric or medical disorder that could influence cognitive functions
* Combined vision with optimal correction below 0.6 on Snellen Visual Acuity Test
* Unable or unwilling to undergo EEG or MRI
* Refusing informed consent
18 Years
65 Years
ALL
No
Sponsors
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National MS Center Melsbroek
OTHER
Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
OTHER
Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Principal Investigators
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Guy Nagels
Role: PRINCIPAL_INVESTIGATOR
Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel
Locations
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Universitair Ziekenhuis Brussel
Brussels, , Belgium
National MS Center Melsbroek
Melsbroek, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Guy Nagels
Role: primary
Miguel D'Haeseleer
Role: primary
References
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Van Laethem D, Van de Steen F, Kos D, Naeyaert M, Van Schuerbeek P, D'Haeseleer M, D'Hooghe MB, Van Schependom J, Nagels G. Cognitive-motor telerehabilitation in multiple sclerosis (CoMoTeMS): study protocol for a randomised controlled trial. Trials. 2022 Sep 14;23(1):778. doi: 10.1186/s13063-022-06697-9.
Other Identifiers
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1SD5322N
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CoMoTeMS
Identifier Type: -
Identifier Source: org_study_id
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