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Aerobic Training Effects on Motor and Cognitive Performances in MS: an Exploratory Study With Structural and Functional MRI

NCT04097418 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-09-28

No results posted yet for this study

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 motor and cognitive performances. The Investigators wish to explore the role of AT in multiple sclerosis (MS) patients on physical and neuropsychological functions and its underlying anatomical and functional substrates, using advanced magnetic resonance imaging (MRI) methods.

In this project, the Investigators wish to apply aerobic training in right-handed MS patients and healthy controls to assess:

1. the effects of aerobic training compared to conventional motor training on motor and cardio-vascular parameters;
2. the effect of aerobic training compared to conventional motor training on cognitive performance, depression and fatigue;
3. the modifications of functional activations during a cognitive task and of functional connectivity in motor and cognitive networks during resting state following aerobic training and conventional motor training (functional plasticity);
4. the regional variations of gray matter (GM) volumes and white matter (WM) architecture after aerobic training and conventional motor training (structural plasticity);
5. the correlations between the changes detected with structural and functional MRI and clinical, motor and neuropsychological scales.

Conditions

Interventions

BEHAVIORAL

Aerobic training compared to conventional motor training

Aerobic training: aerobic training by treadmill at moderate intensity. Each treatment will consists of 35 minutes of training, administered 3 times per week, for 8 weeks. Conventional motor training: 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, administered 3 times per week, for 8 weeks.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Massimo Filippi, MD · IRCCS San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-13
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04097418 on ClinicalTrials.gov