Exercise Intensity and Immune Function in Multiple Sclerosis

Status unknownNot a drug-phase studyMS (type not specified)NCT02264704

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • High intensity exericse
  • Moderate intensity exericse

What it measured

Main measures

  • Change in serum brain-derived neurotrophic factor (BDNF) level

    Chronic - Baseline, week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise

Other measures (11)

  • Change in serum nerve growth factor (NGF) level

    Chronic - Baseline, week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise

  • Change in serum interleukin-4 (IL-4) level

    Chronic - Baseline (week 0), week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise

    Immune response
  • Change in serum interferon gamma (IFN-γ) level

    Chronic - Baseline (week 0), week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise

    Immune response
  • Change in mobility

    Baseline, weeks 5, 10, 15 and follow up (week 20)

    Walking and mobility
  • Change in exercise capacity

    Baseline, weeks 5, 10, 15 and follow up (week 20)

    Walking and mobilityPhysical function
  • Change in fatigue

    Baseline, weeks 5, 10, 15 and follow up (week 20)

    Fatigue
  • Change in health-related quality of life

    Baseline, weeks 5, 10, 15 and follow up (week 20)

    Quality of life (reported by participants)
  • Change in cognitive ability

    Baseline, weeks 5, 10, 15 and follow up (week 20)

    Thinking and memory
  • Number of sessions attended

    15 weeks

    Physical functionQuality of life (reported by participants)
  • Change in cardiorespiratory fitness

    Baseline and week 15

    Physical function

Who could take part

MS (type not specified) · 18 to 60 · EDSS 3.0 to 5.0

Show the full criteria

Inclusion criteria

* Clinically confirmed MS (according to the revised 2010 McDonald criteria) (Polman et al., 2011) * Expanded disability status scale (EDSS) 3.0-5.0

Exclusion criteria

* Unable to consent due cognitive impairment or mental illness * Immunomodulatory therapy in past 3 months * Steroid therapy in the past 6 weeks * Existence of medical contraindications for exercise i.e. cardiovascular or orthopaedic disease. * Compounding neurological condition other than MS

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

About this trial

In the sponsor's words

This study aims to determine the effect of exercise intensity within a 15 week programme in moderately disabled people with multiple sclerosis (MS). Although earlier research has shown that exercise is safe and may improve health related factors such as mobility and fatigue, the intensity at which exercise offers the most benefit has not yet been defined. Participants will be randomly assigned to one of three groups - high intensity, moderate intensity or usual care. Participants in the exercising groups (high and moderate intensity) will take part in a supervised 15 week cycling exercise programme based in the Douglas Grant Rehabilitation Centre. Those assigned to the usual care (control) group will continue to receive their usual medical care and will not participate in the exercise programme. The acute immune response to exercise will also be measured. Participants from all three groups will be monitored regularly. Clinical outcomes of the study include immunological markers, exercise capacity, mobility, fatigue, quality of life and cognitive ability. These will be measured by a combination of blood tests, physical assessments and questionnaires. It is hypothesised that high intensity exercise will cause a favourable, anti-inflammatory response which will be associated with greater improvements in physical and psychological outcomes than both moderate intensity exercise and usual care.

Papers

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History

    1. Started

      Nov 2014

    2. Main results due

      Jul 2015

    3. Finished

      Jul 2015

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