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Exercise Intensity and Immune Function in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02264704
Recruitment Status : Unknown
Verified October 2014 by Ryan Bell, University of the West of Scotland.
Recruitment status was:  Not yet recruiting
First Posted : October 15, 2014
Last Update Posted : October 15, 2014
Sponsor:
Collaborator:
National Heatlh Service Ayrshire and Arran
Information provided by (Responsible Party):
Ryan Bell, University of the West of Scotland

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: High intensity exericse Other: Moderate intensity exericse Not Applicable

Detailed Description:

Recruited patients will initially undergo baseline measurements including BMI. Neurotrophin (BDNF and NGF) and cytokine (IFN-Y and IL-4) concentration will be measured from participant serum using commercially available ELISA kits (R&D systems).

Assessments of cognitive ability, mood, fatigue and quality of life will also be performed using psychometric tests as described in outcomes. Exercise capacity and mobility will be also be measured.

Participants will also undergo a maximal exercise test, recently validated for use in this patient population (Heine et al., 2014). Briefly, rested participants will initially cycle at a power of 25W whilst maintaining a minimum cadence of 60rpm as a 5 minute warm-up. This leads directly into the testing period, during which the power is increased incrementally (15W per minute) until the point of volitional termination or a drop in cadence of 10rpm below the minimum (60 rpm). Peak oxygen consumption (VO2 peak) is used as a measure of cardiorespiratory fitness.

Participants will be randomly assigned to one of three groups - high intensity (HI), moderate intensity (MI) or usual care (UC). Exercising groups will take part in a 15 week programme. All exercise will be performed on a cycle ergometer and will be carried out twice per week for 15 weeks (30 sessions) at the Douglas Grant Rehabilitation Centre, Irvine. In all sessions HI participants will exercise intermittently (30 seconds on 30 seconds off) at 80% of the peak power (based on maximal exercise test) for 15 minutes. MI participants will exercise continuously at 40% peak power for 15 minutes. To ensure exercise intensity remains consistent throughout the programme the workload will progressively increase over time to accommodate any increases in participant fitness levels as measured by %HR. UC participants will not participate in the supervised exercise programme but will continue to receive their usual care.

5 weeks after completion of the exercise programme, a follow-up testing session will occur.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise Intensity and Immune Function in Multiple Sclerosis
Study Start Date : November 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High intensity exercise
High intensity exercise Participants will exercise at high intensity (70% VO2 peak) intermittently (30 seconds on, 30 seconds off) for 15 minutes, twice weekly for 15 weeks.
Other: High intensity exericse
Participants will exercise at high intensity (70% VO2 peak) intermittently (30 seconds on, 30 seconds off) for 15 minutes, twice weekly for 15 weeks. Workload may increase as the study progresses based on heart rate response.

Experimental: Moderate intensity exercise
Participants exercise at moderate intensity (35% VO2 peak) continuously for 15 minutes, twice weekly for 15 weeks.
Other: Moderate intensity exericse
Participants exercise at moderate intensity (35% VO2 peak) continuously for 15 minutes, twice weekly for 15 weeks. Workload may increase as the study progresses based on heart rate response.

No Intervention: Usual Care
Participants receive usual medical care.



Primary Outcome Measures :
  1. Change in serum brain-derived neurotrophic factor (BDNF) level [ Time Frame: Chronic - Baseline, week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise ]
    The level of brain-derived neurotrophic factor in participant serum will be determined by analysing blood samples using commercially available ELISA assays.


Secondary Outcome Measures :
  1. Change in serum nerve growth factor (NGF) level [ Time Frame: Chronic - Baseline, week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise ]
    The level of nerve growth factor in participant serum will be determined by analysing blood samples using commercially available ELISA assays.

  2. Change in serum interleukin-4 (IL-4) level [ Time Frame: Chronic - Baseline (week 0), week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise ]
    The level of interleukin-4 in participant serum will be determined by analysing blood samples using commercially available ELISA assays.

  3. Change in serum interferon gamma (IFN-γ) level [ Time Frame: Chronic - Baseline (week 0), week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise ]
    The level of interferon gamma in participant serum will be determined by analysing blood samples using commercially available ELISA assays.

  4. Change in mobility [ Time Frame: Baseline, weeks 5, 10, 15 and follow up (week 20) ]
    Participant mobility and balance will be assessed by the timed up and go test (TUG). Individuals safely rise from a standard armchair, walk a distance of 3 metres, turn around and return to a seated position. Usual walking aids may be used however personal assistance is not permitted.

  5. Change in exercise capacity [ Time Frame: Baseline, weeks 5, 10, 15 and follow up (week 20) ]
    Exercise capacity will be assessed by the six minute walk test (6MWT). Participants walk continuously, turning at a defined distance, until six minutes have passed. Total distance travelled is the measured outcome.

  6. Change in fatigue [ Time Frame: Baseline, weeks 5, 10, 15 and follow up (week 20) ]
    Self-reported fatigue will be assessed by the 21 item modified fatigue impact scale (MFIS) which has been previously validated for use in this patient population.

  7. Change in health-related quality of life [ Time Frame: Baseline, weeks 5, 10, 15 and follow up (week 20) ]
    Health-related quality of life will be assessed by the 29 item multiple sclerosis impact scale questionnaire (MSIS-29). MSIS-29 analyses both mental and physical aspects of quality of life.

  8. Change in cognitive ability [ Time Frame: Baseline, weeks 5, 10, 15 and follow up (week 20) ]
    The brief international cognitive assessment for multiple sclerosis (BICAMS) is a short test battery which assesses information processing speed, visual memory and verbal learning ability.

  9. Number of sessions attended [ Time Frame: 15 weeks ]
    Adherence will be measured by number of exercise sessions attended across the 15 week intervention (30 sessions).

  10. Change in cardiorespiratory fitness [ Time Frame: Baseline and week 15 ]
    Peak oxygen consumption (VO2 peak) will be measured via a maximal exercise test tailored for this patient population (Heine et al., 2014).

  11. Change in mood [ Time Frame: Baseline, weeks 5, 10, 15 and follow up (week 20) ]
    Mood will be assessed by the hospital anxiety and depression scale (HADS). HADS is a 14 item questionnaire designed to analyse self-reported indicators of anxiety and depression.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264704


Contacts
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Contact: Paul Mattison, MD 441294323031 drmattison@aaaht.scot.nhs.uk
Contact: Ryan Bell, MSc 447593052652 ryan.bell@uws.ac.uk

Locations
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United Kingdom
Douglas Grant Rehabilitation Centre, Ayrshire Central Hospital Not yet recruiting
Irvine, Ayrshire, United Kingdom, KA12 8SS
Contact: Paul Mattison, MD    441294323031    drmattison@aaaht.scot.nhs.uk   
Principal Investigator: Ryan Bell, MSc         
Sponsors and Collaborators
University of the West of Scotland
National Heatlh Service Ayrshire and Arran
Investigators
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Principal Investigator: Ryan Bell, MSc University of the West of Scotland

Publications:
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Responsible Party: Ryan Bell, Postgraduate Student, University of the West of Scotland
ClinicalTrials.gov Identifier: NCT02264704     History of Changes
Other Study ID Numbers: 157624 ( Registry Identifier: Integrated Research Application Service (IRAS) )
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014
Keywords provided by Ryan Bell, University of the West of Scotland:
MS
Exercise
Training
Multiple sclerosis
Immune response
Neurotrophin
Cytokine
Fatigue
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases