Aerobic Training Effects on Motor and Cognitive Performances in MS: an Exploratory Study With Structural and Functional MRI
Multiple Sclerosis
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Aerobic Training, rehabilitation
Eligibility 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.
Sites / Locations
- IRCCS San RaffaeleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
Aerobic training in healthy subjects
Conventional motor training of healthy subjects
Aerobic training in MS patients
Conventional motor training of MS patients
For each healthy subject, the treatment will lasts 8 weeks. Each treatment will consists of 35 minutes of training, administered 3 times per week. Subjects of the experimental groups (both patients and healthy controls) will carry out an aerobic training of moderate intensity (fixed time and variable intensity) on a treadmill. The training will be set individually via direct method: during the first session, the subject will be trained at an intensity that gets the heart rate (HR) corresponding to 46-63% of VO2 peak measured during the exercise test; in subsequent sessions the intensity will increase to maintain the same HR, which will be always monitored. The intensity workout identified will be maintained for 30 minutes each session, preceded and followed by a few minutes of warm-up and cool-down.
For each healthy subject, the treatment will lasts 8 weeks. Each treatment will consists of 35 minutes of training, administered 3 times per week. Control groups of both patients and healthy subjects will follow a conventional non-aerobic physiotherapy training, structured in: 15 minutes of passive mobilization of upper and lower limbs and spine, 5 minutes of stretching of the upper and the lower limbs and 10 minutes of balance training.
For each MS patient, the treatment will lasts 8 weeks. Each treatment will consists of 35 minutes of training, administered 3 times per week. Subjects of the experimental groups (both patients and healthy controls) will carry out an aerobic training of moderate intensity (fixed time and variable intensity) on a treadmill. The training will be set individually via direct method: during the first session, the subject will be trained at an intensity that gets the heart rate (HR) corresponding to 46-63% of VO2 peak measured during the exercise test; in subsequent sessions the intensity will increase to maintain the same HR, which will be always monitored. The intensity workout identified will be maintained for 30 minutes each session, preceded and followed by a few minutes of warm-up and cool-down.
For each MS patient, the treatment will lasts 8 weeks. Each treatment will consists of 35 minutes of training, administered 3 times per week. Control groups of both patients and healthy subjects will follow a conventional non-aerobic physiotherapy training, structured in: 15 minutes of passive mobilization of upper and lower limbs and spine, 5 minutes of stretching of the upper and the lower limbs and 10 minutes of balance training.