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

NCT06056960 | Unknown

• 1 other identifier: 03_17/02/2021 Part B
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Sclerosis

Keywords

early phase; non-disabled

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Differences in oxygenated hemoglobin (Delta oxyHb)

  Baseline, Post, FollowUp_6month

• Six Minute walking test (6MWT)

  Baseline, Post, FollowUp_6month

• Number of steps/day

  Baseline, Post, FollowUp_6month

• Endurance walking capacity

  Baseline, Post, FollowUp_6month

Study Arms (2)

Physical Activity

EXPERIMENTAL

The experimental group will perform a combination of endurance and balance training tailored to the subject.

Other: Tailored Physical Activity

Usual Activity

NO INTERVENTION

The control group will perform their usual daily activities.

Interventions

Tailored Physical Activity OTHER

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.

Physical Activity

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• IRCCS San Raffaele: collaborator
• Azienda Sanitaria Locale di Cagliari: collaborator

Study Sites (3)

Ospedale Binaghi ASL Cagliari

Cagliari, Italy

Location

IRCCS Ospedale San Raffele

Milan, 20100, Italy

Location

IRCCS Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 28, 2023
• Study Start: July 15, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-07

Locations

IT (3)