Multiple SclerosisNCT02264704
Exercise Intensity and Immune Function in Multiple Sclerosis
A study testing High intensity exericse and Moderate intensity exericse in people with Multiple Sclerosis, run by University of the West of Scotland at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- High intensity exericse and Moderate intensity exericse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically confirmed MS (according to the revised 2010 McDonald criteria) (Polman et al., 2011)
- Expanded disability status scale (EDSS) 3.0-5.0
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Douglas Grant Rehabilitation Centre, Ayrshire Central Hospital
Irvine, Ayrshire, KA12 8SS
Paul Mattison, MD, 441294323031, drmattison@aaaht.scot.nhs.uk
Ryan Bell, MSc
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- High intensity exericse, Moderate intensity exericse
- Keywords
- MS, Exercise, Training, Multiple sclerosis, Immune response, Neurotrophin, Cytokine, Fatigue
- Medical subject headings
- Multiple Sclerosis, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity exericseOther
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.
Moderate intensity exericseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise | Experimental | 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. Receives: Other: High intensity exericse |
| Moderate intensity exercise | Experimental | Participants exercise at moderate intensity (35% VO2 peak) continuously for 15 minutes, twice weekly for 15 weeks. Receives: Other: Moderate intensity exericse |
| Usual Care | No intervention | Participants receive usual medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum brain-derived neurotrophic factor (BDNF) level
The level of brain-derived neurotrophic factor in participant serum will be determined by analysing blood samples using commercially available ELISA assays.
Measured: Chronic - Baseline, week 7, week 15 and follow-up (week 20). Acute - 15 mins, 30 mins and 1 hour post-exercise
Secondary outcomes (11)
Change in serum nerve growth factor (NGF) level
The level of nerve growth factor in participant serum will be determined by analysing blood samples using commercially available ELISA assays.
Measured: 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
The level of interleukin-4 in participant serum will be determined by analysing blood samples using commercially available ELISA assays.
Measured: 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
The level of interferon gamma in participant serum will be determined by analysing blood samples using commercially available ELISA assays.
Measured: 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
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.
Measured: Baseline, weeks 5, 10, 15 and follow up (week 20)
Change in exercise capacity
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.
Measured: Baseline, weeks 5, 10, 15 and follow up (week 20)
Change in fatigue
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.
Measured: Baseline, weeks 5, 10, 15 and follow up (week 20)
Change in health-related quality of life
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.
Measured: Baseline, weeks 5, 10, 15 and follow up (week 20)
Change in cognitive ability
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.
Measured: Baseline, weeks 5, 10, 15 and follow up (week 20)
Number of sessions attended
Adherence will be measured by number of exercise sessions attended across the 15 week intervention (30 sessions).
Measured: 15 weeks
Change in cardiorespiratory fitness
Peak oxygen consumption (VO2 peak) will be measured via a maximal exercise test tailored for this patient population (Heine et al., 2014).
Measured: Baseline and week 15
Change in mood
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.
Measured: Baseline, weeks 5, 10, 15 and follow up (week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the West of Scotland
- Sponsor type
- University, hospital or other
- Collaborators
- National Heatlh Service Ayrshire and Arran
- Responsible party
- Principal investigator, Ryan Bell, University of the West of Scotland
- Investigators
- Ryan Bell, MSc, Principal investigator, University of the West of Scotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264704
- Other IDs
- 157624
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Heine M, Hoogervorst EL, Hacking HG, Verschuren O, Kwakkel G. Validity of maximal exercise testing in people with multiple sclerosis and low to moderate levels of disability. Phys Ther. 2014 Aug;94(8):1168-75. doi: 10.2522/ptj.20130418. Epub 2014 Mar 27.
PubMed 24677255Collett J, Dawes H, Meaney A, Sackley C, Barker K, Wade D, Izardi H, Bateman J, Duda J, Buckingham E. Exercise for multiple sclerosis: a single-blind randomized trial comparing three exercise intensities. Mult Scler. 2011 May;17(5):594-603. doi: 10.1177/1352458510391836. Epub 2011 Jan 19.
PubMed 21247971
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intensity and Immune Function in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02264704
- Conditions
- Multiple Sclerosis
- Keywords
- MS, Exercise, Training, Multiple sclerosis, Immune response, Neurotrophin, Cytokine, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University of the West of ScotlandUniversity, hospital or other
- Collaborators
- National Heatlh Service Ayrshire and Arran
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise | Experimental | Other: High intensity exericseHigh 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. |
| Moderate intensity exercise | Experimental | Other: Moderate intensity exericseParticipants exercise at moderate intensity (35% VO2 peak) continuously for 15 minutes, twice weekly for 15 weeks. |
| Usual Care | No intervention | –Participants receive usual medical care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinically confirmed MS (according to the revised 2010 McDonald criteria) (Polman et al., 2011)
- Expanded disability status scale (EDSS) 3.0-5.0
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity exericseParticipants 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. | Other | High intensity exercise |
| Moderate intensity exericseParticipants 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. | Other | Moderate intensity exercise |
Primary outcome
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.
11 secondary outcomes
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
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
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
Change in mobility
Time frame: 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)
Change in fatigue
Time frame: 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)
Change in cognitive ability
Time frame: Baseline, weeks 5, 10, 15 and follow up (week 20)
Number of sessions attended
Time frame: 15 weeks
Change in cardiorespiratory fitness
Time frame: Baseline and week 15
Change in mood
Time frame: Baseline, weeks 5, 10, 15 and follow up (week 20)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
- Background: PubMed 24677255Heine M, Hoogervorst EL, Hacking HG, Verschuren O, Kwakkel G. Validity of maximal exercise testing in people with multiple sclerosis and low to moderate levels of disability. Phys Ther. 2014 Aug;94(8):1168-75. doi: 10.2522/ptj.20130418. Epub 2014 Mar 27.
- Background: PubMed 21247971Collett J, Dawes H, Meaney A, Sackley C, Barker K, Wade D, Izardi H, Bateman J, Duda J, Buckingham E. Exercise for multiple sclerosis: a single-blind randomized trial comparing three exercise intensities. Mult Scler. 2011 May;17(5):594-603. doi: 10.1177/1352458510391836. Epub 2011 Jan 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Bell, MSc principal investigator
University of the West of Scotland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity exericse and Moderate intensity exericse in people with Multiple Sclerosis, run by University of the West of Scotland at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Mattison, MD (441294323031, drmattison@aaaht.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02264704, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.