Exercise Intensity and Immune Function in Multiple Sclerosis

October 8, 2014 updated by: Ryan Bell, University of the West of Scotland

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Ayrshire
      • Irvine, Ayrshire, United Kingdom, KA12 8SS
        • Douglas Grant Rehabilitation Centre, Ayrshire Central Hospital
        • Contact:
        • Principal Investigator:
          • Ryan Bell, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Chronic - Baseline (week 0), week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise
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.
Chronic - Baseline (week 0), week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise
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.
Baseline, weeks 5, 10, 15 and follow up (week 20)
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.
Baseline, weeks 5, 10, 15 and follow up (week 20)
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.
Baseline, weeks 5, 10, 15 and follow up (week 20)
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.
Baseline, weeks 5, 10, 15 and follow up (week 20)
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.
Baseline, weeks 5, 10, 15 and follow up (week 20)
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).
15 weeks
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).
Baseline and week 15
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.
Baseline, weeks 5, 10, 15 and follow up (week 20)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the West of Scotland

Collaborators

National Heatlh Service Ayrshire and Arran

Investigators

  • Principal Investigator: Ryan Bell, MSc, University of the West of Scotland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 8, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 157624 (Registry Identifier: Integrated Research Application Service (IRAS))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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