Effects of aerobic training on motor and cognitive functions in multiple sclerosis patients
Effects of Aerobic Training on Motor and Cognitive Performances in Patients With MS: an Exploratory Study With Structural and Functional MRI
This study is testing whether aerobic exercise can improve movement and thinking skills in people with multiple sclerosis compared to regular rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT04097418 on ClinicalTrials.gov |
What this trial studies
This study explores the impact of aerobic training on motor and cognitive performance in patients with multiple sclerosis (MS) using advanced MRI techniques. It involves a randomized, controlled design where MS patients and healthy controls will undergo either aerobic training or conventional motor rehabilitation. The study aims to assess changes in physical and neuropsychological functions, as well as the underlying anatomical and functional brain changes associated with these interventions. Participants will be monitored for improvements in cardiovascular parameters, cognitive performance, depression, and fatigue.
Who should consider this trial
Good fit: Ideal candidates include right-handed individuals aged 18 to 65 with a diagnosis of multiple sclerosis and an EDSS score of 6 or lower.
Not a fit: Patients with additional neurological, psychiatric, orthopedic, or rheumatologic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation strategies for MS patients, improving their motor and cognitive functions.
How similar studies have performed: Other studies have shown promising results with aerobic training in neurological rehabilitation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria (All) * Age between 18 and 65 years; * Native italian language speaking; * Right-handed; * No particular motor skills; * No additional neurologic, psychiatric, orthopaedic or rheumatologic diseases; * Normal or corrected-to-normal vision; * No contraindications to MRI; * Ability to understand the purpose of the study and provide signed informed consent. For MS patients, the following additional inclusion criteria will be applied: * Patients with a diagnosis of MS, regardless of sex, duration and course of the disease; * EDSS score ranging from 0 to 6.0 (included); * Stable treatment for MS from at least 1 month prior to study enrolment; * Relapse- and steroid-free from at least 3 months before screening visit; * An indication to perform a physiotherapy treatment by the treating physician. Exclusion Criteria: * Persons who perform regularly a structured training; * Patients who performed a physiotherapy treatment for at least 3 months; * Concomitant therapy with antidepressant, baclofen, psychoactive, and steroids drugs as well as symptomatic treatment for fatigue; * History of alcohol or substance abuse; * Pregnancy or breastfeeding.
Where this trial is running
Milan
- IRCCS San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Massimo Filippi, MD — IRCCS San Raffaele
- Study coordinator: Massimo Filippi, MD
- Email: filippi.massimo@hsr.it
- Phone: 00390226433054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.