Promoting Aerobic Training in Multiple Sclerosis

Aerobic Training as Substrate for Neural Plastic Changes in Multiple Sclerosis: a Putative Disease-modifying Treatment?

Status unknownNot a drug-phase studyRelapsing MSNCT05212805

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Aerobic exercise
  • Sport events participation

Given to everyone in the trial

  • Task-oriented upper-limb training

What it measured

Main measures

  • Change in the 6 minute walk test (6mWT) performance

    Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)

    Walking and mobilityPhysical function

Other measures (17)

  • Change in the Timed 25-Foot Walk test (T25FW) performance

    Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)

    Disability progressionWalking and mobility

  • Change in the Nine Hole Peg Test (NHPT) performance

    Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)

    Arm and hand function

  • Change in the Modified Fatigue Impact Scale (MFIS) score

    Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)

    Thinking and memoryFatigueQuality of life (reported by participants)

  • Change in the Short Form Health Survey (SF-36) score

    Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)

    Quality of life (reported by participants)

  • Structural and functional plasticity of the Central Nervous System (CNS)

    Baseline (T0), after 8 weeks (T1), after 16 weeks (T2)

    MRI lesionsMyelin repairNerve conduction tests

  • Interview

    Up to 2 years after the intervention

    Quality of life (reported by participants)

  • Change in the Hand Grip Strength Test (HGST) performance

    Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)

    Arm and hand functionPhysical function

  • Change in the Pinch Strength Test (PST) performance

    Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)

    Physical function

  • Change in the Timed Up and Go (TUG) performance

    Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)

    Walking and mobility

  • Change in the Timed Up and Go cognitive (TUG-cog) performance

    Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)

    Thinking and memoryWalking and mobility

Who could take part

Relapsing MS · 18 and over

Show the full criteria

Inclusion criteria

* Multiple sclerosis diagnosis according to McDonald criteria * relapsing-remitting course * absence of relapses in the last three months * an Expanded Disability Status Score (EDSS) ≤ 4

Exclusion criteria

* steroid-use, psychiatric disorders or severe cognitive impairment * acute cardio-respiratory diseases * magnetic resonance imaging contraindications

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Multiple sclerosis (MS) is a chronic neurological disease characterized by inflammation and degeneration within the central nervous system. Over the course of the disease, most patients with MS successively accumulate inflammatory lesions and axonal damage with an increasing degree of disability. Thus, pharmacological treatment options are currently adopted to limit inflammation and to decrease the relapse rate, or simply to alleviate symptoms. On the other hand, neurorehabilitation aims to maintain and possibly improve the residual capacities of neurological patients in order to preserve personal and social activities, constituting an important part of quality health care for MS patients. However, to date, there is no definite agreement on which specific exercise therapy program can be considered the most successful in improving activities and participation. Several studies suggest that a training based on voluntary movements produces greater improvements than a passive treatment. Aerobic exercise training has been also shown to have significant neurophysiological effects in different populations. Furtherly, sports activity may increase adherence and motivation, especially in a young population such as the MS community. However, feasibility of sports activity has not been investigated yet and, in general, the potential interest of these approaches for MS patients remains to determine. This study aims at promoting physical activity in people with MS. Specific objectives are: (i) to evaluate the motor behavioral and neural changes induced by aerobic exercise combined with upper limb motor training based on task-oriented exercises; (ii) to assess the feasibility of leisure time physical activity (e.g. water sports activities) largely involving upper limb function. Participants will receive task-oriented treatment, but only the experimental group will perform also aerobic training in order to evaluate the effect of aerobic exercise. Moreover, the role of sports activities will be preliminary investigated, by promoting the participation of the included patients to local or national events focusing on adapted aerobic sports specifically involving upper limb function (e.g., water sports such as sailing, windsurfing, canoeing). Clinical measures will be performed before and after interventions.

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History

    1. Started

      Jan 2018

    2. Main results due

      Jun 2023

    3. Finished

      Dec 2023

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