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| ID | Type | Description | Link |
|---|---|---|---|
| 031A130 | Other Grant/Funding Number | BMBF |
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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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Cognitive dysfunction is frequent in patients with multiple sclerosis (MS) and to date, there are no available treatments to improve cognition in this patient population. Some evidence from animal studies and small clinical trials suggest that aerobic exercise might beneficially affect cognitive function in MS. The aim of this randomized-controlled trial is to explore if an aerobic exercise training program can enhance cognition in MS. In addition, we will employ neuroimaging markers to determine if exercise alters measures of brain structure and function.
Patients will be randomly assigned to either a 3-months exercise program (bicycle ergometry, 2-3 session per week) or a waitlist control group. The primary endpoint of the study is a test of verbal learning and memory. Secondary endpoints include neuroimaging markers of functional and structural connectivity in the brain. We hypothesize that exercise will improve verbal learning and memory and beneficially affect measures of brain connectivity.
Background: Cognitive dysfunction is frequent in patients with multiple sclerosis (MS) and to date, there are no available treatments to improve cognition in this patient population. Some evidence from animal studies and small clinical trials suggest that aerobic exercise might beneficially affect cognitive function in MS.
Aims: This study aims to explore the potential of an aerobic exercise program on brain structure and function in MS in a single-blind, randomized controlled phase IIa trial. We hypothesize that exercise will improve verbal learning and memory (primary endpoint) as well as induce changes in neuroimaging markers of structural and functional central nervous system (CNS) connectivity (secondary endpoints). Tertiary outcomes will include walking ability, motor function and coordination, as well as patient-based outcomes (depression, fatigue, and health-related quality of life).
Design: This is a single-blind, randomized, controlled phase IIa trial with a parallel group design comparing 3 months of standardized aerobic exercise training (bicycle ergometry) to a waitlist control group (superiority framework). The allocation ratio of exercise to waitlist control is 1:1 with a sample size of n=60.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise (12 Weeks) | Experimental | Aerobic exercise on a bicycle ergometer, tailored to the individual's level of fitness. Duration: 12 weeks with 2-3 sessions per week. |
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| Waitlist Control Group | No Intervention | No intervention (patients randomized to this group will be offered access to the training program after completion of the trial) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Behavioral | 3-months exercise program tailored to the individual level of aerobic fitness. Patients will exercise on a bicycle ergometer (2-3 session per week) according to a predefined training plan with increasing duration and intensity |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Verbal Learning and Memory | Verbal Learning and Memory will be assessed with the Verbal Learning and Memory Test (VLMT) | Baseline and at Month 3 (end of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Connectivity | Functional connectivity of CNS networks will be assessed by resting-state functional magnetic resonance imaging (rs fMRI) and resting-state magnetoencephalography (rs MEG) | Baseline and at Month 3 (end of intervention) |
| Change in Structural Connectivity |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-Reported Outcomes | Patient-reported outcomes will be assessed for depressive symptoms (IDS-30SR), fatigue (FSMC), quality of life (HAQUAMS), and walking (MSWS-12) | Baseline and at Month 3 (end of intervention) |
| Change in Walking Ability |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan M Gold, PhD | Center for Molecular Neurobiology, University Hospital Hamburg Eppendorf | Principal Investigator |
| Andreas K Engel, MD | Dept Neurophysiology, University Hospital Hamburg Eppendorf | Principal Investigator |
| Christoph Heesen, MD | Dept Neurology, University Hospital Hamburg Eppendorf | Principal Investigator |
| Guido Nolte, PhD | Dept Neurophysiology, University Hospital Hamburg Eppendorf | Principal Investigator |
| Karl-Heinz Schulz, MD, PhD | Dept Sports Medicine, University Hospital Hamburg Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hamburg-Eppendorf | Hamburg | 20241 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30581662 | Derived | Baquet L, Hasselmann H, Patra S, Stellmann JP, Vettorazzi E, Engel AK, Rosenkranz SC, Poettgen J, Gold SM, Schulz KH, Heesen C. Short-term interval aerobic exercise training does not improve memory functioning in relapsing-remitting multiple sclerosis-a randomized controlled trial. PeerJ. 2018 Dec 12;6:e6037. doi: 10.7717/peerj.6037. eCollection 2018. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Structural connectivity and integrity of CNS networks will be assessed by diffusion tensor imaging (DTI) as well as measures of gray matter density using magnetic resonance imaging (MRI) |
| Baseline and at Month 3 (end of intervention) |
| Change in Neuropsychological Function | Neuropsychological function will be assessed using a standardized battery covering the following domains: visuospatial learning and memory, attention, processing speed, working memory, and social cognition | Baseline and at Month 3 (end of intervention) |
Walking ability will be assessed using the six-minute-walk test (6MWT) as well as Actibelt accelerometry
| Baseline and at Month 3 (end of intervention) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |