Impact of 8-weeks Mild Exercise Training on "Invisible" Symptoms and Quality of Life in Ambulatory and Non-ambulatory (EDSS From 0.0 - 8.0) Individuals With Multiple Sclerosis: a Randomized Controlled Trial

CompletedNot a drug-phase studyMS (type not specified)NCT03768830

What it found

Paper found, not read

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

What was tested

Treatment tested

  • Exercise training

What it measured

Main measures

  • Change of fatigue intensity

    baseline, up to 8 weeks

    Thinking and memoryFatigue
  • Change of pain intensity

    baseline, up to 8 weeks

    Pain
  • Change in quality of life

    baseline, up to 8 weeks

    PainQuality of life (reported by participants)
  • Change in sleeping quality - ISI

    baseline, up to 8 weeks

    Mood and sleepQuality of life (reported by participants)
  • Change in sleeping quality - PSQI

    baseline, up to 8 weeks

    Myelin repairMood and sleep
  • Change in psychological symptoms

    baseline, up to 8 weeks

  • Change in Headache-Migraine intensity and frequency

    baseline, up to 8 weeks

Other measures (1)

  • Motivation evaluation

    up 8 weeks

Who could take part

MS (type not specified) · 18 to 80 · EDSS 0 to 8

Show the full criteria

Inclusion criteria

* Individuals with multiple sclerosis (EDSS 0-8) * Ambulatory and non-ambulatory (in wheelchairs)

Exclusion criteria

* Individuals with contraindications for exercising * Individuals with multiple sclerosis with EDSS over 8

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

About this trial

In the sponsor's words

Patients with multiple sclerosis (MS) struggle on a daily basis with accompanying, "Invisible" symptoms like primary fatigue, pain and emotional-cognitive disorders. With the disease progression, these symptoms only intensify, and in combination with basic physical symptoms, quality of life (QOL) rapidly decreases. An important goal of researchers and clinicians involves improving the QOL of individuals with MS, and the exercise therapy represents potentially modifiable behavior that positively impacts on pathogenesis of MS and these "Invisible" symptoms, thus improving the QOL. However, the main barrier for its application is low motivational level that MS patients experience due to fatigue with adjacent reduced exercise tolerability and mobility, and muscle weakness. Getting individuals with MS motivated to engage in continuous physical activity may be particularly difficult and challenging, especially those with severe disability or Expanded Disability Status Scale (EDSS 6-8). Till now, researchers have focused their attention mainly on the moderate or vigorous intensity of exercise and on cardiorespiratory training in MS patients to achieve improvements in daily life quality, less indicating the exercise content, and most importantly, breathing exercises. In addition, it is investigators intention to make exercise for MS patients more applicable and accessible, motivational and easier, but most important, productive. Investigators think that MS patients experience more stress with aerobic exercise or moderate to high intensity program exercise, and can hardly keep continuum including endurance exercise, or treadmill. Hypothesis: Investigators hypothesis is that 8-weeks of continuous low demanding or mild exercise program with the accent on breathing exercise can attenuate primary fatigue, pain, headaches, emotional-cognitive and sleep dysfunctions in MS patients and provide maintenance of exercise motivation. Investigators also propose that important assistant factor for final goal achievement is social and mental support of the exercise group (EDSS from 0-8) led by a physiotherapist. This will help to maintain exercise motivation and finally make better psychophysical functioning, and thus better QOL.

Papers

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History

    1. Started

      Oct 2018

    2. Main results due

      Feb 2019

    3. Finished

      Feb 2019

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