Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part B

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Tailored Physical Activity

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Cagliari, Italy
    • Ospedale Binaghi ASL Cagliari
  • Milan, Italy, 20148
    • IRCCS Fondazione Don Carlo Gnocchi
  • Milan, Italy, 20100
    • IRCCS Ospedale San Raffele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Activity; The experimental group will perform a combination of endurance and balance training tailored to the subject.	Other: Tailored Physical Activity; The intervention will comprise 16 sessions (2 sessions/week). 30 minutes of walking training wearing a heart rate (HR) monitor to keep exercise intensity below 70% of maximal HR. Right after, 30 minutes of balance exercises will be performed. An experienced physical therapist will tailor exercises. Subjects will be taught how to perform the exercises by themselves. A booklet will be provided to provide guidelines. A physical therapist will call subjects, every training day to check for any problem.
No Intervention: Usual Activity; The control group will perform their usual daily activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Severity Scale (FSS)	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.	Baseline, Post, FollowUp_6month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in oxygenated hemoglobin (Delta oxyHb)	The differences in oxyHb during task period and resting state. Data will be extracted from functional Near InfraRed Spectroscopy (fNIRS) assessment.	Baseline, Post, FollowUp_6month
Six Minute walking test (6MWT)	Gait asymmetry and regularity extracted from Inertial Measurement Unit's during the six minute walking test.	Baseline, Post, FollowUp_6month
Number of steps/day	Assessed by activity trackers, a non-invasive method of monitoring human rest/activity cycles. Subjects will be monitored for 1 week wearing an actigraph.	Baseline, Post, FollowUp_6month
Endurance walking capacity	Assessed as the distance walked over 6 minutes as a sub-maximal test of endurance (6MWT).	Baseline, Post, FollowUp_6month

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Collaborators: IRCCS San Raffaele; Azienda Sanitaria Locale di Cagliari
• Investigators: Principal Investigator: Marco Rovaris, MD, IRCCS Fondazione Don Carlo Gnocchi; Principal Investigator: Raffaella Chieffo, MD, Irccs Ospedale San Raffaele; Principal Investigator: Eleonora Cocco, MD, Ospedale Binaghi ASL Cagliari, Sardegna

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: early phase; non-disabled
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 03_17/02/2021 Part B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No