Multiple SclerosisNCT05212805
Promoting Aerobic Training in Multiple Sclerosis
A study testing Aerobic exercise, Task-oriented upper-limb training and Sport events participation in people with Multiple Sclerosis, run by Fondazione Italiana Sclerosi Multipla at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Aerobic exercise, Task-oriented upper-limb training and Sport events participation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 25 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- steroid-use, psychiatric disorders or severe cognitive impairment
- acute cardio-respiratory diseases
- magnetic resonance imaging contraindications
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Italian Multiple Sclerosis Association and Foundation
Genoa, GE, 16149
Giampaolo Brichetto, MD, PhD, 0102713532 ext. 503, giampaolo.brichetto@aism.it
About this study
Official title: Aerobic Training as Substrate for Neural Plastic Changes in Multiple Sclerosis: a Putative Disease-modifying Treatment?
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
- Being tested
- Aerobic exercise, Task-oriented upper-limb training, Sport events participation
- Keywords
- Aerobic exercise, Sports activity, Motor performance, Neural plasticity, Participation, Upper limb
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
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 trainingBehavioural
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 participationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Promotion | Experimental | This group will be submitted to an aerobic exercise program combined with upper-limb motor training. Receives: 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. Receives: Behavioral: Task-oriented upper-limb training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The T25FW is a clinical tool that evaluates patients for quantitative mobility and leg function performance test in a timed, 25 foot walk
Measured: 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
The NHPT is a standardized, quantitative assessment used to measure finger dexterity
Measured: 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
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).
Measured: 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
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)
Measured: 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)
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.
Measured: Baseline (T0), after 8 weeks (T1), after 16 weeks (T2)
Interview
Semi-structured interview deputed to explore eventual long-term effects of the intervention and effects on daily living activities and quality of life.
Measured: Up to 2 years after the intervention
Change in the Hand Grip Strength Test (HGST) performance
HGST is a tool measuring the maximum isometric strength of the hand and forearm muscles
Measured: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
Change in the Pinch Strength Test (PST) performance
PST is a tool measuring the maximum isometric strength between thumb and index
Measured: 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
TUG is a simple evaluative test used to measure functional mobility
Measured: 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
TUG-cog is a simple evaluative test used to measure functional mobility during dual-task performances
Measured: 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
The AMSQ is a patient reported outcome on upper limb functioning (Minimum value: 31; maximum value: 186; higher scores mean a worse outcome)
Measured: 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
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).
Measured: 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
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)
Measured: 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
Brief IPQ is a self-report measure of illness perceptions (Minimum value: 0; maximum value: 70; higher scores mean a worse outcome)
Measured: 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
A tracker (smart watch or bracelet) monitors the time of activity of participants (minutes/day).
Measured: Baseline (i.e., 1 month before intervention), during sports activity (if applicable) and 1 month after intervention
Continuous monitoring of calories expenditure
A tracker (smart watch or bracelet) monitors the calories expenditure (calories/day).
Measured: Baseline (i.e., 1 month before intervention), during sports activity (if applicable) and 1 month after intervention
Questionnaire on acceptability
Yes/No questionnaire composed by five questions evaluating satisfaction the intervention and its organization
Measured: After 5 days of sports activity (if applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Jan 2018
- Primary completion24 Jun 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Sclerosi Multipla
- Sponsor type
- University, hospital or other
- Collaborators
- Universita degli Studi di Genova, University Grenoble Alps
- Responsible party
- Sponsor
- Investigators
- Giampaolo Brichetto, MD, PhD, Principal investigator, Italian Multiple Sclerosis Association and Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212805
- Sponsor's protocol ID
- ARSEP
- Status last verified
- Jan 2022
- First submitted
- 2 Nov 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Training as Substrate for Neural Plastic Changes in Multiple Sclerosis: a Putative Disease-modifying Treatment?
- ClinicalTrials.gov ID
- NCT05212805
- Acronym / sponsor ID
- ARSEP
- Conditions
- Multiple Sclerosis
- Keywords
- Aerobic exercise, Sports activity, Motor performance, Neural plasticity, Participation, Upper limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Fondazione Italiana Sclerosi MultiplaUniversity, hospital or other
- Collaborators
- Universita degli Studi di Genova, University Grenoble Alps
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 24 Jun 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Promotion | Experimental | Behavioral: Aerobic exercise, Behavioral: Task-oriented upper-limb training, Behavioral: Sport events participationThis group will be submitted to an aerobic exercise program combined with upper-limb motor training. |
| Control | Active comparator | Behavioral: Task-oriented upper-limb trainingThis group will be submitted to a standard motor rehabilitation. No aerobic nor sport activity will be delivered to the Control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- steroid-use, psychiatric disorders or severe cognitive impairment
- acute cardio-respiratory diseases
- magnetic resonance imaging contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseInterventions 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. | Behavioural | Aerobic Exercise Promotion |
| Task-oriented upper-limb trainingThe 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. | Behavioural | Aerobic Exercise Promotion, Control |
| Sport events participationA 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. | Behavioural | Aerobic Exercise Promotion |
Primary outcome
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
17 secondary outcomes
Change in the Timed 25-Foot Walk test (T25FW) performance
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline (T0), after 8 weeks (T1), after 16 weeks (T2)
Interview
Time frame: Up to 2 years after the intervention
Change in the Hand Grip Strength Test (HGST) performance
Time frame: Baseline (T0), after 5 days of sports activity (Ti, if applicable), after 8 weeks (T1), after 16 weeks (T2)
Change in the Pinch Strength Test (PST) performance
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (i.e., 1 month before intervention), during sports activity (if applicable) and 1 month after intervention
Continuous monitoring of calories expenditure
Time frame: Baseline (i.e., 1 month before intervention), during sports activity (if applicable) and 1 month after intervention
Questionnaire on acceptability
Time frame: After 5 days of sports activity (if applicable)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giampaolo Brichetto, MD, PhD principal investigator
Italian Multiple Sclerosis Association and Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise, Task-oriented upper-limb training and Sport events participation in people with Multiple Sclerosis, run by Fondazione Italiana Sclerosi Multipla at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giampaolo Brichetto, MD, PhD (0102713532 ext. 503, giampaolo.brichetto@aism.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022; AzTrials last refreshed its copy on 31 Oct 2026.