Status:
UNKNOWN
Aerobic Training Effects on Motor and Cognitive Performances in MS: an Exploratory Study With Structural and Functional MRI
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Aerobic training (AT) induces cardiovascular, metabolic and muscular changes and has been proposed as a promising rehabilitative approach in elderly adults and in neurological patients to improve both...
Detailed Description
This study is a monocentric, non-pharmacological, longitudinal, randomized, blind, controlled study. Subjects The Investigators will study 40 right-handed MS patients with Expanded Disability Status ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04097418
Start Date
June 13 2015
End Date
December 31 2024
Last Update
September 28 2023
Active Locations (1)
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1
IRCCS San Raffaele
Milan, Italy, 20132