Clinical trial NCT06056960: Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part B
Official title: Preventing the Progression of Physical Disability and Promoting Brain Functional Adaptation in People With Multiple Sclerosis: Integration of Early Rehabilitative Treatment and Multimodal Clinical and Instrumental Assessment - Part B
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Multiple Sclerosis
Keywords: early phase
non-disabled
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
name: Azienda Sanitaria Locale di Cagliari
First posted: 2023-09-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is widely recognized that physical exercise is safe and people with moderate Multiple Sclerosis (MS) are encouraged to train regularly to improve their skills in motor task execution. Several studies demonstrated that these activities represent an effective low-cost therapy which leads to significant and clinically meaningful improvements in gait and balance in people with MS (PwMS) with mild to moderate walking dysfunction, possibly also by promoting brain plasticity.

There is general agreement within the scientific community on the importance of timing intervention also during the early stages of MS to preserve or improve walking and balance abilities and fostering brain functional adaptation, thus slowing down the disease progression. Previous studies highlighted the need to early identify and manage gait disorders using a multimodal approach tailored on individual's need. Moreover, Functional Near-Infrared Spectroscopy (fNIRS) measures blood flow which accompanies neuronal activity and thus, it can provide spatial information about changes in cortical activation patterns due to the possible effects of exercise on cortical plasticity.

To the best of the investigators knowledge, no published studies have assessed the effect of exercise on mobility and brain activity in PwMS with minimal or clinically undetectable disability. This emphasizes the need of trials investigating the effect of walking exercise as preventive strategy on MS clinical worsening.


Eligibility criteria: Inclusion Criteria:

* Age \> 17 years
* Stable disease course (without worsening over 1 point at the Expanded Disability Status Scale in the last 3 months)

Exclusion Criteria:

* Major depression
* Mini-Mental State Examination \< 27
* Other cardiovascular or orthopedic diseases that interfere with physical exercise
* Progressive course of the disease

Primary outcomes:
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline, Post, FollowUp_6month
Secondary outcomes:
measure: Differences in oxygenated hemoglobin (Delta oxyHb)
timeFrame: Baseline, Post, FollowUp_6month
measure: Six Minute walking test (6MWT)
timeFrame: Baseline, Post, FollowUp_6month
measure: Number of steps/day
timeFrame: Baseline, Post, FollowUp_6month
measure: Endurance walking capacity
timeFrame: Baseline, Post, FollowUp_6month
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Ospedale Binaghi ASL Cagliari
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffele
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Marco Rovaris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Ospedale San Raffaele
name: Raffaella Chieffo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Binaghi ASL Cagliari, Sardegna
name: Eleonora Cocco, MD
role: PRINCIPAL_INVESTIGATOR
References: