Clinical trial NCT05212805: Promoting Aerobic Training in Multiple Sclerosis
Official title: Aerobic Training as Substrate for Neural Plastic Changes in Multiple Sclerosis: a Putative Disease-modifying Treatment?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Aerobic exercise
Sports activity
Motor performance
Neural plasticity
Participation
Upper limb
Lead sponsor: Fondazione Italiana Sclerosi Multipla
Sponsor class: OTHER
Collaborators: name: Universita degli Studi di Genova
name: University Grenoble Alps
First posted: 2022-01-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in the 6 minute walk test (6mWT) performance
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
Secondary outcomes:
measure: Change in the Timed 25-Foot Walk test (T25FW) performance
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Change in the Nine Hole Peg Test (NHPT) performance
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Change in the Modified Fatigue Impact Scale (MFIS) score
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Change in the Short Form Health Survey (SF-36) score
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Structural and functional plasticity of the Central Nervous System (CNS)
timeFrame: Baseline (T0), after 8 weeks (T1), after 16 weeks (T2)
measure: Interview
timeFrame: Up to 2 years after the intervention
measure: Change in the Hand Grip Strength Test (HGST) performance
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Change in the Pinch Strength Test (PST) performance
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Change in the Timed Up and Go (TUG) performance
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Change in the Timed Up and Go cognitive (TUG-cog) performance
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Change in the Arm Function in Multiple Sclerosis Questionnaire (AMSQ) score
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Change in the 12-Item MS Walking Scale (MSWS-12) score
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Change in the Dual-task Impact of Daily Activities Questionnaire (DIDA-Q) score
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Change in the Brief Illness Perception Questionnaire (Brief IPQ) score
timeFrame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
measure: Continuous monitoring of the time of activity
timeFrame: Baseline (i.e., 1 month before intervention), during sports activity (if applicable) and 1 month after intervention
measure: Continuous monitoring of calories expenditure
timeFrame: Baseline (i.e., 1 month before intervention), during sports activity (if applicable) and 1 month after intervention
measure: Questionnaire on acceptability
timeFrame: After 5 days of sports activity (if applicable)
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: Italian Multiple Sclerosis Association and Foundation
state: GE
Study officials:
affiliation: Italian Multiple Sclerosis Association and Foundation
name: Giampaolo Brichetto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: