Promoting Aerobic Training in Multiple Sclerosis

NCT ID: NCT05212805

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2023-12-25

Brief Summary

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aerobic Exercise Promotion

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

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: BEHAVIORAL

Interventions will be delivered through twenty supervised 40-minutes aerobic sessions (3 times a week). Patients will be trained on a bicycle ergometer (5-minute warm-up, 30 minute of intense training, 5-minute cool-down). Warm-up will be performed at the 30% of the maximal heart rate, while training will be performed at the 50-70% of the maximal heart rate as recommended by the general guidelines for aerobic exercise training specific for MS. Actual heart rate will be constantly monitored by a wearable heart rate monitor.

Task-oriented upper-limb training

Intervention Type: BEHAVIORAL

The training will consist in twenty 1-hour sessions (3 times a week) of exercises for neuromuscular control to improve proprioceptive sensibility, muscle strength, stability and coordination of the upper limbs, including unimanual and bimanual task-oriented exercises.

Sport events participation

Intervention Type: BEHAVIORAL

A subgroup of participants will also be involved in events promoting sports activity including both aerobic and task-oriented exercises (e.g., water sports such as sailing, windsurfing, canoeing) in order to evaluate their potential role to increase adherence to training, participation and quality of life.

Control

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

Group Type: ACTIVE_COMPARATOR

Task-oriented upper-limb training

Intervention Type: BEHAVIORAL

The training will consist in twenty 1-hour sessions (3 times a week) of exercises for neuromuscular control to improve proprioceptive sensibility, muscle strength, stability and coordination of the upper limbs, including unimanual and bimanual task-oriented exercises.

Interventions

Aerobic exercise

Interventions will be delivered through twenty supervised 40-minutes aerobic sessions (3 times a week). Patients will be trained on a bicycle ergometer (5-minute warm-up, 30 minute of intense training, 5-minute cool-down). Warm-up will be performed at the 30% of the maximal heart rate, while training will be performed at the 50-70% of the maximal heart rate as recommended by the general guidelines for aerobic exercise training specific for MS. Actual heart rate will be constantly monitored by a wearable heart rate monitor.

Intervention Type: BEHAVIORAL

Task-oriented upper-limb training

The training will consist in twenty 1-hour sessions (3 times a week) of exercises for neuromuscular control to improve proprioceptive sensibility, muscle strength, stability and coordination of the upper limbs, including unimanual and bimanual task-oriented exercises.

Intervention Type: BEHAVIORAL

Sport events participation

A subgroup of participants will also be involved in events promoting sports activity including both aerobic and task-oriented exercises (e.g., water sports such as sailing, windsurfing, canoeing) in order to evaluate their potential role to increase adherence to training, participation and quality of life.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita degli Studi di Genova

OTHER

Sponsor Role: collaborator

University Grenoble Alps

OTHER

Sponsor Role: collaborator

Fondazione Italiana Sclerosi Multipla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giampaolo Brichetto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Italian Multiple Sclerosis Association and Foundation

Locations

Italian Multiple Sclerosis Association and Foundation

Genoa, GE, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giampaolo Brichetto, MD, PhD

Role: CONTACT

giampaolo.brichetto@aism.it

0102713532 ext. 503

Facility Contacts

Giampaolo Brichetto, MD, PhD

Role: primary

giampaolo.brichetto@aism.it

0102713532 ext. 503

Other Identifiers

ARSEP

Identifier Type: -

Identifier Source: org_study_id