Effects of an Endurance Training Program at Ventilatory Threshold on the Walking Distance of Ambulatory Patients With Multiple Sclerosis

Stopped earlyNot a drug-phase studyProgressive MSNCT02874677

What it found

Stopped

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

Reason given: material issues in study centres

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

  • Effort reeducation program

What it measured

Main measures

  • Distance estimated by the 6 minutes Walk Test

    Change in baseline at 6 weeks and at 3 months

    Walking and mobility

Other measures (7)

  • Walking speed measured by the timed 25-ft walk test (T25FWT)

    Change in baseline at 6 weeks and at 3 months

    Disability progressionWalking and mobility
  • Heart rate estimation at the end of the 6 minutes walk test

    Change in baseline at 6 weeks and at 3 months

    Walking and mobility
  • Walking perception measured by the Twelve Item MS Walking Scale (MSWS-12) scale

    Change in baseline at 6 weeks and at 3 months

    Walking and mobility
  • Effort test for the estimation of the maximal consumption of oxygen (O2max)

    Change in baseline at 6 weeks and at 3 months

  • Multiple sclerosis-59 French scale for the estimation of the quality of life

    Change in baseline at 6 weeks and at 3 months

    Quality of life (reported by participants)
  • Fatigue Impact Scale (EMIF-SEP)

    Change in baseline at 6 weeks and at 3 months

    Fatigue
  • Effort test for the estimation of the ventilatory threshold (VT1)

    Change in baseline at 6 weeks and at 3 months

Who could take part

Progressive MS · 18 to 65 · EDSS 4 to 6

Show the full criteria

Inclusion criteria

* People with remittent or progressive multiple sclerosis defined by the criteria of Mc Donald revised in 2005 * Expended Disability Status Scale (EDSS) between 4 and 6 * Age between 18 and 65 years old * No defined relapse of MS for at least 6 weeks * At least more than 4 weeks since the last corticoids bolus * Coverage of the social insurance

Exclusion criteria

* Understanding disorders * Medical history of orthopaedic or and rheumatologic invalidating * Contraindications to test effort, after a cardiological consultation and ECG * Cardiovascular and respiratory diseases not stabilized * Osteo-articular diseases not stabilized * Pregnant or breast-feeding woman

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

About this trial

In the sponsor's words

Multiple sclerosis (MS) is a disease affecting the white matter of the central nervous system. In France, it concerns approximately 80 000 patients and represents one of the most frequent neurological affections in young adults. Effort deconditioning of people affected by MS is already proven, but it is not just linked to the disease itself. The decrease of capacities to produce an effort is aggravated by neurovegetative and cardiovascular disorders. The limitation or the complete stop of physical activity is often linked to the fear of a handicap aggravation. Causes of stop are multiple, including fatigue and balance disorders, even if the handicap level is low (average EDSS = 2). Walking disorders generated by MS are frequent, represent the first symptom of the disease (10 to 20 % of cases) and alter significantly the quality of life. Some reeducation programs were proposed in hospitalization with some efficiency on functional capacities. It is now admitted that physical exercise is not noxious, and allows the implementation of effort reeducation for MS. Randomized controlled studies have shown in MS patients an improvement of physical abilities, of O2max (aerobic capacity), of quality of life and a decrease of fatigue. For MS, only a few studies estimate the effect of effort reeducation on treadmill. Unfortunately, the efficiency of these programs on walking endurance are controversial. During the maximal cardiorespiratory effort test, the ventilatory threshold 1 (VT1) corresponds to a greater increasing of CO2 compared to O2. The identification of VT1 allows the precise determination of the limit from which the body is incapable of producing the necessary energy to realize an effort using the aerobic metabolism. The VT1 is situated at a level of load with enough intensity for the subject to support the test without dyspnea. A VT1 lower than 40 % of the theoretical VO2 max is considered as a marker of maladjustment to effort due to dyspnea and excessive muscular fatigue. This indication is very informative about the quality of life of patients. The goal of this study is to apply a personalized reeducation concerning the working load pre-hyperventilation to deconditioned subjects, easily worried by effort induced breathlessness and fatigue in order to get the optimization of the aerobic function. The hypothesis is that reeducation at this level improves the distance of walking and the quality of life of patients affected by MS.

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History

    1. Started

      Dec 2017

    2. Main results due

      Jan 2022

    3. Finished

      Jan 2022

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