Promoting Aerobic Training in Multiple Sclerosis

NCT05212805 | Unknown

• 1 other identifier: ARSEP
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Keywords

Aerobic exercise; Sports activity; Motor performance; Neural plasticity; Participation; Upper limb

Outcome Measures

Primary Outcomes (1)

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

  The 6mWT assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance

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

Secondary Outcomes (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)

• 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)

• 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)

• 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)

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

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

Study Arms (2)

Aerobic Exercise Promotion

EXPERIMENTAL

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

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

Control

ACTIVE COMPARATOR

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

Behavioral: Task-oriented upper-limb training

Interventions

Aerobic exercise 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.

Aerobic Exercise Promotion

Task-oriented upper-limb training 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.

Aerobic Exercise Promotion; Control

Sport events participation 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.

Aerobic Exercise Promotion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Italiana Sclerosi Multipla: lead
• Universita degli Studi di Genova: collaborator
• University Grenoble Alps: collaborator

Study Sites (1)

Italian Multiple Sclerosis Association and Foundation

Genoa, GE, 16149, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Giampaolo Brichetto, MD, PhD

  Italian Multiple Sclerosis Association and Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giampaolo Brichetto, MD, PhD

CONTACT

0102713532; giampaolo.brichetto@aism.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: January 28, 2022
• Study Start: January 1, 2018
• Primary Completion: June 24, 2023
• Study Completion: December 25, 2023
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

IT (1)