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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06056960
Other study ID # 03_17/02/2021 Part B
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 15, 2024
Est. completion date January 30, 2025

Study information

Verified date July 2023
Source Fondazione Don Carlo Gnocchi Onlus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 80
Est. completion date January 30, 2025
Est. primary completion date January 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Ospedale Binaghi ASL Cagliari Cagliari
Italy IRCCS Fondazione Don Carlo Gnocchi Milan
Italy IRCCS Ospedale San Raffele Milan

Sponsors (3)

Lead Sponsor Collaborator
Fondazione Don Carlo Gnocchi Onlus Azienda Sanitaria Locale di Cagliari, IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Endurance walking capacity Assessed as the distance walked over 6 minutes as a sub-maximal test of endurance (6MWT). Baseline, Post, FollowUp_6month
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