Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part B
Primary Purpose
Multiple Sclerosis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tailored Physical Activity
Sponsored by
About this trial
This is an interventional prevention trial for Multiple Sclerosis focused on measuring early phase, non-disabled
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
Sites / Locations
- Ospedale Binaghi ASL Cagliari
- IRCCS Ospedale San Raffele
- IRCCS Fondazione Don Carlo Gnocchi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physical Activity
Usual Activity
Arm Description
The experimental group will perform a combination of endurance and balance training tailored to the subject.
The control group will perform their usual daily activities.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Six Minute walking test (6MWT)
Gait asymmetry and regularity extracted from Inertial Measurement Unit's during the six minute walking test.
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.
Endurance walking capacity
Assessed as the distance walked over 6 minutes as a sub-maximal test of endurance (6MWT).
Full Information
NCT ID
NCT06056960
First Posted
September 11, 2023
Last Updated
September 25, 2023
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
IRCCS San Raffaele, Azienda Sanitaria Locale di Cagliari
1. Study Identification
Unique Protocol Identification Number
NCT06056960
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 15, 2024 (Anticipated)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
January 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
IRCCS San Raffaele, Azienda Sanitaria Locale di Cagliari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
early phase, non-disabled
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical Activity
Arm Type
Experimental
Arm Description
The experimental group will perform a combination of endurance and balance training tailored to the subject.
Arm Title
Usual Activity
Arm Type
No Intervention
Arm Description
The control group will perform their usual daily activities.
Intervention Type
Other
Intervention Name(s)
Tailored Physical Activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue Severity Scale (FSS)
Description
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.
Time Frame
Baseline, Post, FollowUp_6month
Secondary Outcome Measure Information:
Title
Differences in oxygenated hemoglobin (Delta oxyHb)
Description
The differences in oxyHb during task period and resting state. Data will be extracted from functional Near InfraRed Spectroscopy (fNIRS) assessment.
Time Frame
Baseline, Post, FollowUp_6month
Title
Six Minute walking test (6MWT)
Description
Gait asymmetry and regularity extracted from Inertial Measurement Unit's during the six minute walking test.
Time Frame
Baseline, Post, FollowUp_6month
Title
Number of steps/day
Description
Assessed by activity trackers, a non-invasive method of monitoring human rest/activity cycles. Subjects will be monitored for 1 week wearing an actigraph.
Time Frame
Baseline, Post, FollowUp_6month
Title
Endurance walking capacity
Description
Assessed as the distance walked over 6 minutes as a sub-maximal test of endurance (6MWT).
Time Frame
Baseline, Post, FollowUp_6month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Rovaris, MD
Organizational Affiliation
IRCCS Fondazione Don Carlo Gnocchi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raffaella Chieffo, MD
Organizational Affiliation
IRCCS Ospedale San Raffaele
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eleonora Cocco, MD
Organizational Affiliation
Ospedale Binaghi ASL Cagliari, Sardegna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Binaghi ASL Cagliari
City
Cagliari
Country
Italy
Facility Name
IRCCS Ospedale San Raffele
City
Milan
ZIP/Postal Code
20100
Country
Italy
Facility Name
IRCCS Fondazione Don Carlo Gnocchi
City
Milan
ZIP/Postal Code
20148
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Preventing the Progression of Multiple Sclerosis: Early Rehabilitative Treatment and Multimodal Assessment - Part B
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