Self-Management Program Based on Physical Exercises in People With Mul

Self-Management Program Based on Physical Exercises for People With Multiple Sclerosis With Mild Neurological Impairment: A Randomized Controlled Trial

Status unknownNot a drug-phase studyRelapsing and progressiveNCT02607020

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Physical exercises in an self-management setting

Compared with

  • Relaxation

What it measured

Main measures

  • Fatigue

    28 days

    Fatigue

  • Change in fatigue

    Evaluation at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention

    Fatigue

Other measures (12)

  • Safety (Number of patients with adverse events related to treatment).

    Through study completion, an average of 9 months

    Safety

  • Change in MS-specific health related quality of life

    2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention

    Quality of life (reported by participants)

  • Change in walking capacity

    2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention

    Walking and mobility

  • Change in plasmatic cytokines: IFNg

    Baseline and immediately after the intervention

    Immune response

  • Change in plasmatic cytokines: TNFa

    Baseline and immediately after the intervention

    Immune response

  • Adherence

    Weekly through the intervention (during 3 months)

    Quality of life (reported by participants)

  • Amount of physical activity performed

    From the first day after the completion of the treatment, every 3 months up to 6 months.

    Physical function

  • Change in Cardiorespiratory fitness

    2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention

    Physical function

  • Change in Lower limbs spasticity

    2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention

    Spasticity

  • Change in objective walking endurance

    2 evaluations at baseline, one immediately after the intervention program, one 3 months afterward and the last one 6 months after the end of the intervention

    Walking and mobility

Who could take part

Relapsing and progressive · 18 to 65

Show the full criteria

Inclusion criteria

* A diagnosis of MS performed by a specialized neurologist (revised McDonald criteria, 2010), regardless of the form of the disease (relapsing-remitting, primary progressive, secondary progressive); * An EDSS score less than or equal to 3.5, with a functional score less than or equal to 2 for the pyramidal and cerebellar functions; * An age between 18 and 65 years.

Exclusion criteria

* An affection of one or both lower limbs limiting their ability to walk; * Another illness contraindicating the practice of exercises (ACSM criteria, 2011); * An episode of relapse within the 4 weeks prior to inclusion; * Participation in a study targeting rehabilitation, within the 3 months prior to inclusion; * Modification of drug treatment of MS (disease-modifying treatment and symptomatic treatment) in the 3 months prior to inclusion; * Change in the physiotherapy prescription within the 3 months prior to inclusion. * Pregnancy * Participation in a regular exercise program at least 3 times a week for at least 30 minutes for more than 6 months.

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

About this trial

In the sponsor's words

Fatigue is the most chronic and disabling symptom in multiple sclerosis patients. Self-management physical exercise programs seem promising to allow patients to improve their fatigue and their deconditioning. However, the effectiveness of such programs has been poorly assessed until now. The objectives of the present study are to evaluate the relationships between fatigue and physical capacity among slightly affected MS patients, and to carry on a large trial to assess the effectiveness of a self-management exercise program in the same patients. Sixty-four patients will be included and will be asked, after an educational period, to perform at least three exercise sessions of more than 30 minutes each week, over a period of three months. Patients will be splitted in two groups : one group will perform endurance and resistance physical exercises, and the other one will perform relaxation exercises with the help of soothing music. A regular coaching will adapt the exercises and motivate the patients to continue the treatment. Assessors won't be informed of patients' treatment. Four evaluations will be done, and will notably assess muscle strength, endurance, fatigue and social participation.

Papers

Loading reviews and guidelines…

History

    1. Started

      Dec 2015

    2. Main results due

      Dec 2018

    3. Finished

      Jan 2020

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