Role of Individualized Versus Traditional Exercise in Combating Fatigu

Role of Individualized Versus Traditional Exercise in Combating Fatigue in Fatigued Multiple Sclerosis Patients

Stopped earlyNot a drug-phase studyRelapsing MSNCT04796272

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: low inclusion rates

This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Adapted and individualized physical training program

Compared with

  • traditional training program

What it measured

Main measures

  • Chronic fatigue score

    Month 3

    Fatigue

Other measures (12)

  • cardiorespiratory fitness

    Month 3

    Physical function

  • Hematological parameters

    Month 3

  • Inflammatory parameters

    Month 3

  • quality of sleep

    Month 3

    Mood and sleep

  • cortical activation level

    Month 3

  • cortico-spinal excitability

    Month 3

  • neuromuscular fatigue of peripheral function

    Month 3

    Fatigue

  • Analysis overall quality of life : Fatigue questionnaire

    Month 3

    FatigueQuality of life (reported by participants)

  • Analysis overall quality of life :Quality of Life

    Month 3

    Quality of life (reported by participants)

  • Analysis overall quality of life :Depression

    Month 3

    Mood and sleepQuality of life (reported by participants)

Who could take part

Relapsing MS · 18 to 70

Show the full criteria

Inclusion criteria

* Aged 18 to 70 years old * Male or female * With relapsing-remitting multiple sclerosis (RRMS) as defined by McDonald's 2010 criteria. * Between 2 and 25 years from the onset of multiple sclerosis * With a high level of fatigue, corresponding to a score of Fatigue Severity Scale> 4 and Fatigue questionnaire > 38. * Expanded Disability Status Scale Score 5 * Testing ≥ 4 in all leg muscles. * Ability to walk for 10 minutes without stopping (self-reported) * Affiliates or beneficiaries of a social security scheme * Having freely given their written consent after having been informed of the purpose, course of action and potential risks involved

Exclusion criteria

* Severe cerebellar spasticity or ataxia in either leg. * Abnormal range of motion of the toes and/or ankle. * Musculoskeletal injury that interferes with pedaling. * High resting heart rate (>90 beats per minute). * Blood pressure > 144/94 mmHg. * Onset of a multiple sclerosis attack within 90 days prior to the study. * Recent adjustment of any medication or drugs that may impact on fatigue, or taking stimulants for fatigue (e.g. Modafinil). * Taking of neuro-active substances that may impair cortico-spinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) throughout the study period. * Contraindication to the application of a magnetic field * History of co-morbid disease or conditions that would compromise the subject's safety during the study. * Participation at the same time in another medical intervention study or having participated in such a study within 30 days prior to this study. * Pregnant and Nursing Women * Women of childbearing age without effective contraception * Patient unable to understand the purpose and conditions of the study, incapable of giving consent * Patient deprived of liberty or patient under guardianship

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

About this trial

In the sponsor's words

The objective of this project will be to characterise the benefits of an exercise programme adapted to each individual's abilities compared to a traditional exercise programme with the aim of reducing perceived fatigue and improving the quality of life of Patients with multiple sclerosis.

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History

    1. Started

      Apr 2021

    2. Main results due

      Feb 2022

    3. Finished

      Jun 2022

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