Promoting Aerobic Training in Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Behavioral: Aerobic exerciseBehavioral: Task-oriented upper-limb trainingBehavioral: Sport events participation
- Registration Number
- NCT05212805
- Lead Sponsor
- Fondazione Italiana Sclerosi Multipla
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 62
- 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
- steroid-use, psychiatric disorders or severe cognitive impairment
- acute cardio-respiratory diseases
- magnetic resonance imaging contraindications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aerobic Exercise Promotion Aerobic exercise This group will be submitted to an aerobic exercise program combined with upper-limb motor training. Aerobic Exercise Promotion Sport events participation This group will be submitted to an aerobic exercise program combined with upper-limb motor training. Control Task-oriented upper-limb training This group will be submitted to a standard motor rehabilitation. No aerobic nor sport activity will be delivered to the Control group. Aerobic Exercise Promotion Task-oriented upper-limb training This group will be submitted to an aerobic exercise program combined with upper-limb motor training.
- Primary Outcome Measures
Name Time Method Change in the 6 minute walk test (6mWT) performance 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 Outcome Measures
Name Time Method 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) The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in a timed, 25 foot walk
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) The NHPT is a standardized, quantitative assessment used to measure finger dexterity
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) TUG-cog is a simple evaluative test used to measure functional mobility during dual-task performances
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) The MFIS is a patient reported outcome on the effects of fatigue in terms of physical, cognitive, and psychosocial functioning (Minimum value: 0; maximum value: 84; higher scores mean a worse outcome).
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) DIDA-Q is a self-report measure of the perceived difficulties of dual-tasking (Minimum value: 0; maximum value: 76; higher scores mean a worse outcome)
Structural and functional plasticity of the Central Nervous System (CNS) Baseline (T0), after 8 weeks (T1), after 16 weeks (T2) Brain structure and function will be investigated using Magnetic Resonance Imaging (MRI) and Transcranial Magnetic Stimulations (TMS) in order to detect possible changes induced by the intervention.
MRI measures: axial single-shot spin-echo echo-planar diffusion tensor imaging (DTI) to obtain DTI-derived parametric maps (in particular, fractional anisotropy, axial diffusivity, radial diffusivity and mean diffusivity) TMS measures: motor evoked potential of 1mV at rest (S1mV) in the opponens pollicis (OP) before and after paired associative stimulation (PAS), a protocol known to induce a plastic increase of the primary motor cortex (M1) excitability. PAS consists of an electric stimulus delivered on the median nerve of the right arm 25ms (PAS 25) coupled with a magnetic stimulus administered on M1 in correspondence to the OP area. Two-hundred couples of stimuli will be administered to each participants for a total duration of 14 minutes.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) PST is a tool measuring the maximum isometric strength between thumb and index
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) The AMSQ is a patient reported outcome on upper limb functioning (Minimum value: 31; maximum value: 186; higher scores mean a worse outcome)
Interview Up to 2 years after the intervention Semi-structured interview deputed to explore eventual long-term effects of the intervention and effects on daily living activities and quality of life.
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) HGST is a tool measuring the maximum isometric strength of the hand and forearm muscles
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) MSWS-12 is a self-report measure of the impact of MS on the individual's walking ability (Minimum value: 12; maximum value: 60; higher scores mean a worse outcome).
Continuous monitoring of the time of activity Baseline (i.e., 1 month before intervention), during sports activity (if applicable) and 1 month after intervention A tracker (smart watch or bracelet) monitors the time of activity of participants (minutes/day).
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) The SF-36 is a patient reported outcome that quantifies health status and measures health-related quality of life (Minimum value: 0%; maximum value: 100%; higher scores mean a better outcome)
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) TUG is a simple evaluative test used to measure functional mobility
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) Brief IPQ is a self-report measure of illness perceptions (Minimum value: 0; maximum value: 70; higher scores mean a worse outcome)
Continuous monitoring of calories expenditure Baseline (i.e., 1 month before intervention), during sports activity (if applicable) and 1 month after intervention A tracker (smart watch or bracelet) monitors the calories expenditure (calories/day).
Questionnaire on acceptability After 5 days of sports activity (if applicable) Yes/No questionnaire composed by five questions evaluating satisfaction the intervention and its organization
Trial Locations
- Locations (1)
Italian Multiple Sclerosis Association and Foundation
🇮🇹Genoa, GE, Italy