CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Physical Therapyother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04294979
NCT04294979N/ACompleted

Study on the Interaction Between Immune, Autonomic and Central Nervous Systems as a Target of Exercise Therapy in Multiple Sclerosis

IRCCS San Raffaele Roma·interventional·Posted Mar 4, 2020·Updated May 13, 2025

In Brief

A clinical study evaluating Physical Therapy for Multiple Sclerosis. Completed, enrolled 44 participants across 1 site.

Detailed Summary

Exercise or active rehabilitation is a non-pharmacological approach increasingly used for people with Multiple Sclerosis (MS), in support of disease-modifying therapies (DMTs), with the aim of improving the quality of life and engagement in daily activities. Exercise improves several disease outcomes, like cardiovascular and neuromuscular functions and walking abilities. However, its disease modifying potential is poorly explored. Exercise might target two relevant disease hallmarks that are interconnected, such as the dysregulated immune system and the inflammatory synaptopathy. Exercise might act through the activation of the autonomic part of the vagus nerve, which is an important modulator of both the innate and adaptive immune system, through the so-called cholinergic anti-inflammatory pathway-CAP. This study aims to address the effect of exercise in reducing peripheral inflammation that drives the synaptic pathology and neurodegeneration occurring in the brain of MS patients. Patients will undergo a therapeutic exercise program, consisting of 3 hours of treatment per day, 6 days/week for a total of 6 weeks. The treatment will include both passive and active therapeutic exercises targeted to restore or preserve muscular flexibility, motor coordination and ambulatory function. The day of recruitment (time 0) patients will undergo neurological and mood examination and blood withdrawal to analyze peripheral markers of immune function. Moreover, transcranial magnetic stimulation (TMS) will be used to measure synaptic transmission, while the heart rate variability (HRV) test will be performed to explore vagal function. The effect of exercise will be evaluated at the end of rehabilitation (after 6 weeks-time 1), on the above parameters. A follow up will be included (time 2, 8 weeks after the end of the treatment) to address long-term effects on neurologic and mood measurements as well as peripheral marker levels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsNeuromed IRCCS

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 4, 2020
Enrollment StartFeb 1, 2020
Primary CompletionDec 1, 2023
Study CompletionApr 1, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.3 years ago

Interventions

Physical Therapyother

The rehabilitation program will consist of both passive and active therapeutic exercises specifically aimed at restoring or maintaining muscular flexibility, range of motion, balance, coordination of movements, postural passages and transfers, and ambulation. . Furthermore, advanced robotic therapy such as Lokomat® exoskeleton (Hocoma AG, Volketswil, Switzerland), Biodex® Stability System (BSS, Biodex, Inc, Shirley, NY), G-EO System™ (Reha Technology AG, Olten, Svizzera) and Indego® Therapy (Parker USA), will be used to personalize rehabilitation treatment.