NCT04294979: RehaMS

Exercise Therapy in Multiple Sclerosis

Completed NA Last updated 13 May 2025

What this trial tests

NA trial testing Physical Therapy in Multiple Sclerosis in 44 participants. Completed in 1 April 2024.

Timeline

1 February 2020

Primary endpoint
1 December 2023

1 April 2024

Quick facts

Lead sponsor	IRCCS San Raffaele Roma
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	1 February 2020
Primary completion	1 December 2023
Estimated completion	1 April 2024
Sites	1 location across Italy

Drugs / interventions tested

• Physical Therapy

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

IRCCS San Raffaele Roma — full company profile →

Who can join

Adults 18 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Secretome of Stromal Cancer-Associated Fibroblasts (CAFs): Relevance in Cancer.
   Mishra D, Banerjee D. · · 2023 · cited 24× · PMID 36831295 · DOI 10.3390/cells12040628