Promoting Aerobic Training in Multiple Sclerosis

Fondazione Italiana Sclerosi Multipla

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Behavioral: Sport events participation; Behavioral: Aerobic exercise; Behavioral: Task-oriented upper-limb training

Study type: Interventional

Funder types: Other

Identifiers

NCT05212805

ARSEP

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Aerobic Exercise Promotion

Experimental group

Description:

This group will be submitted to an aerobic exercise program combined with upper-limb motor training.

Treatment:

Behavioral: Sport events participation

Behavioral: Aerobic exercise

Behavioral: Task-oriented upper-limb training

Control

Active Comparator group

Description:

This group will be submitted to a standard motor rehabilitation. No aerobic nor sport activity will be delivered to the Control group.

Treatment:

Behavioral: Task-oriented upper-limb training