CompletedNot a drug-phase studyMS (type not specified)NCT05321927

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

  • Trancutaneous Electrical Nerve Stimulation
  • Strength training

Placebo or sham

  • Sham stimulation

What it measured

Main measures

  • 6-minute walk test

    6 weeks

    Walking and mobilityPhysical function
  • chair-stand test

    6 weeks

    Physical function
  • Fatigue Severity Scale (FSS)

    6 weeks

    Fatigue
  • Modified Fatigue Impact Scale (MFIS)

    6 weeks

    Thinking and memoryFatigue
  • 12-item MS walking scale (MSWS-12)

    6 weeks

    Walking and mobility

Other measures (5)

  • Elbow flexor muscle force (maximal and submaximal levels)

    6 weeks

  • Knee extensor muscle force (maximal and submaximal levels)

    6 weeks

  • Handgrip force

    6 weeks

    Arm and hand function
  • Effort during submaximal contractions with elbow flexors

    6 weeks

  • Effort during submaximal contractions with knee extensors

    6 weeks

Who could take part

MS (type not specified) · 18 and over

Inclusion Criteria: * EDSS score \< 7 * MSWS score > 30 * FSS score > 4 or MFIS score > 38. * no known cardiovascular disorder or having a positive advice on a sport medical examination Exclusion Criteria: * being a participant in an exercise study * having a psychiatric disorder * having cognitive or communication problems which reduces the capacity to understand instructions * planned a change in medication during the training period * having a neurological disorder other than MS * having cardiovascular disorders and no positive advice from a sport medical examination * having a pacemaker or another implantable electronic apparatus. * being pregnant

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

About this trial

In the sponsor's words

Persons with multiple sclerosis (pwMS) often have an increased sense of fatigue. Furthermore, they present walking difficulties which negatively affects their mobility and results in an additional increase of fatigue. Previous literature suggests that transcutaneous electrical nerve stimulation (TENS) of leg muscles might increase their walking capacity and decrease perception of fatigue. In the present study we aim to investigate whether TENS of leg muscles reduces walking difficulties and sense of fatigue in pwMS in comparison with a short strength training protocol or no training. A similar aim is addressed after TENS of elbow flexor muscles. Subjects with relapsing remitting or progressive MS, will undergo transcutaneous electrical nerve stimulation (TENS), strength exercises (SExerc), both TENS and SExerc (COMB) simultaneously, or sham stimulation without training (CON) of both leg and arm muscles. Force and fatigue measurements are performed before, directly after and three weeks after the training sessions and contain walking, fatigue, and strength assessments. Main study parameters are changes in the scores of i) the six-minute walking test (6-MWT), ii) the perceived walking disability (MSWS-12) and iii) fatigue questionnaires (FSS and MFIS). Additional study parameters are changes in muscle force and muscle fatigability.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jan 2023

    2. Main results due

      Mar 2024

    3. Finished

      Mar 2024

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