The Impact of 4-weeks Mild Exercise Training on Living Quality in Ambulatory and Non-ambulatory Multiple Sclerosis Individuals (EDSS From 0-8) in Motivational and Social Supporting Environment: a Randomized Controlled Trial

CompletedNot a drug-phase studyMS (type not specified)NCT03222596

What it found

No results found

We found no results in the registry or in papers.

This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Exercise training

What it measured

Main measures

  • Change of fatigue intensity

    baseline, after 4 weeks

    Fatigue
  • Change of pain intensity

    baseline, after 4 weeks

    Pain
  • Motivation.

    baseline, after 4 weeks

  • Change of physical abilities and limitations.

    baseline, after 4 weeks

  • Change of mental abilities and limitations.

    baseline

    Thinking and memory
  • Change of quality of life.

    baseline, after 4 weeks.

    PainQuality of life (reported by participants)
  • Change of grip strength.

    baseline, after 4 weeks

    Arm and hand functionPhysical function

Who could take part

MS (type not specified) · 21 to 70 · 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

The most common symptom displayed in patients with multiple sclerosis (MS) is a pronounced sense of fatigue that can have negative effect on functional ability and quality of life (QOL). 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 thus 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 programme exercise, and can hardly keep continuum including endurance exercise, or treadmill. Hypothesis: Investigators hypothesis is that 4-weeks of continuous low demanding or mild exercise programme with specific content and an accent on breathing exercise can attenuate primary fatigue in MS patients, especially in those with more severe disability or EDSS from 6-8, 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.

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History

    1. Started

      Jul 2017

    2. Main results due

      Aug 2017

    3. Finished

      Aug 2017

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