Exercise Intensity and Immune Function in Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High intensity exericse

Intervention Type OTHER

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 exercise

Participants exercise at moderate intensity (35% VO2 peak) continuously for 15 minutes, twice weekly for 15 weeks.

Group Type EXPERIMENTAL

Moderate intensity exericse

Intervention Type OTHER

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.

Usual Care

Participants receive usual medical care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No