Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part B
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Tailored Physical Activity
- Registration Number
- NCT06056960
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 80
- Age > 17 years
- Stable disease course (without worsening over 1 point at the Expanded Disability Status Scale in the last 3 months)
- Major depression
- Mini-Mental State Examination < 27
- Other cardiovascular or orthopedic diseases that interfere with physical exercise
- Progressive course of the disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physical Activity Tailored Physical Activity The experimental group will perform a combination of endurance and balance training tailored to the subject.
- Primary Outcome Measures
Name Time Method Fatigue Severity Scale (FSS) Baseline, Post, FollowUp_6month Is a 9-item self-administered questionnaire to measure the perceived impact of fatigue. The minimum score is 9 and maximum score possible is 63. Higher scores represent greater fatigue severity. If the score is calculated as the mean score of the 9 items, the cut-off score for the presence of the symptom fatigue is set as scores higher than 4.
- Secondary Outcome Measures
Name Time Method Endurance walking capacity Baseline, Post, FollowUp_6month Assessed as the distance walked over 6 minutes as a sub-maximal test of endurance (6MWT).
Number of steps/day Baseline, Post, FollowUp_6month Assessed by activity trackers, a non-invasive method of monitoring human rest/activity cycles. Subjects will be monitored for 1 week wearing an actigraph.
Differences in oxygenated hemoglobin (Delta oxyHb) Baseline, Post, FollowUp_6month The differences in oxyHb during task period and resting state. Data will be extracted from functional Near InfraRed Spectroscopy (fNIRS) assessment.
Six Minute walking test (6MWT) Baseline, Post, FollowUp_6month Gait asymmetry and regularity extracted from Inertial Measurement Unit's during the six minute walking test.
Trial Locations
- Locations (3)
IRCCS Ospedale San Raffele
🇮🇹Milan, Italy
IRCCS Fondazione Don Carlo Gnocchi
🇮🇹Milan, Italy
Ospedale Binaghi ASL Cagliari
🇮🇹Cagliari, Italy