An interventional study of Tailored Physical Activity in Multiple Sclerosis, sponsored by Fondazione Don Carlo Gnocchi Onlus. Enrolling by invitation at 3 sites in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Prevention
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
The experimental group will perform a combination of endurance and balance training tailored to the subject.
Other: Tailored Physical Activity
The control group will perform their usual daily activities.
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.
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.
Time frame: Baseline, Post, FollowUp_6month
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Post, FollowUp_6month
Endurance walking capacity
Assessed as the distance walked over 6 minutes as a sub-maximal test of endurance (6MWT).
Time frame: Baseline, Post, FollowUp_6month
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Fondazione Don Carlo Gnocchi Onlus