Aerobic Training as Substrate for Neural Plastic Changes in Multiple Sclerosis: a Putative Disease-modifying Treatment?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Fondazione Italiana Sclerosi Multipla
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Change in the 6 minute walk test (6mWT) performance
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in the 6 minute walk test (6mWT) performance
Time Frame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
The 6mWT assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance
Secondary Outcomes
- 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 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))
- 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 Dual-task Impact of Daily Activities Questionnaire (DIDA-Q) 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))
- 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))
- Change in the Arm Function in Multiple Sclerosis Questionnaire (AMSQ) score(Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2))
- Interview(Up to 2 years after the intervention)
- 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))
- Change in the 12-Item MS Walking Scale (MSWS-12) score(Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2))
- Continuous monitoring of the time of activity(Baseline (i.e., 1 month before intervention), during sports activity (if applicable) and 1 month after intervention)
- 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))
- 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))
- Change in the Brief Illness Perception Questionnaire (Brief IPQ) score(Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2))
- Continuous monitoring of calories expenditure(Baseline (i.e., 1 month before intervention), during sports activity (if applicable) and 1 month after intervention)
- Questionnaire on acceptability(After 5 days of sports activity (if applicable))