Status unknownNot a drug-phase studyMS (type not specified)NCT04097418

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Aerobic training compared to conventional motor training

What it measured

Main measures

  • Longitudinal changes of brain GM volumes following aerobic training or conventional motor training

    2 months

    MRI lesionsPhysical function
  • Longitudinal changes of WM microstructural abnormalities following aerobic training or conventional motor training

    2 months

    MRI lesionsPhysical function
  • Resting State Functional Connectivity MRI changes following aerobic training or conventional motor training

    2 months

    MRI lesionsPhysical functionNerve conduction tests
  • Functional MRI changes following aerobic training or conventional motor training

    2 months

    MRI lesionsThinking and memoryPhysical function
  • Effects of aerobic training compared to conventional motor training on global clinical disability

    2 months

    Disability progressionPhysical function
  • Effects of aerobic training compared to conventional motor training on clinical disability

    2 months

    Disability progressionThinking and memoryWalking and mobilityArm and hand functionPhysical function
  • Effects of aerobic training compared to conventional motor training on behavioural measures

    2 months

    Physical function
  • Effects of aerobic training compared to conventional motor training on spasticity

    2 months

    Physical functionSpasticity
  • Effects of aerobic training compared to conventional motor training on walking ability

    2 months

    Walking and mobilityPhysical function
  • Effects of aerobic training compared to conventional motor training on person's mobility

    2 months

    Walking and mobilityPhysical function

Other measures (4)

  • Effects of aerobic training compared to conventional motor training on cognitive functions

    2 months

    Thinking and memoryPhysical function
  • Effects of aerobic training compared to conventional motor training on fatigue

    2 months

    Thinking and memoryFatiguePhysical function
  • Effects of aerobic training compared to conventional motor training on depression

    2 months

    Thinking and memoryFatiguePhysical functionMood and sleep
  • Effects of aerobic training compared to conventional motor training on quality of life

    2 months

    Physical functionQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 65

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jun 2015

    2. Main results due

      Dec 2024

    3. Finished

      Dec 2024

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