High Intensity Interval Training for People With Mild Multiple Sclerosis: A Feasibility Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Exercise has been shown to improve quality of life in people with multiple sclerosis but most
      exercise programmes are carried out at low to moderate intensities. The next stage in the
      management of the condition is to establish if people with mild Multiple Sclerosis can
      exercise, safely and effectively at a higher intensity. High intensity interval training
      (HIIT) involves repeated bursts of hard exercise interspersed with periods of rest. High
      intensity interval trainingcould be a time efficient and safe option for people with Multiple
      Sclerosis. Potential improvements are; cardiovascular fitness, resistance to fatigue,
      balance, quality of life and attitude to physical exercise.

      Participants will attend two sessions per week for 6 weeks. Each session will involve 6-10
      sets of 60 seconds of high intensity cycling followed by 60 seconds rest. Potential
      participants must have a clinical diagnosis of Mulitple Sclerosis for more than 3 months, an
      EDSS score of less than 2.5, aged 18-65, and had no more than one relapse in the last 2
      years.

      From this study the investigators hope to discover if High Intensity Interval Training is a
      safe and enjoyable form of physical activity for people with mild Multiple Sclerosis. This
      will then hopefully lead to further large research trials.
    

Detailed description: 
      Multiple Sclerosis is an autoimmune disease that is typically progressive and involves damage
      to the nerve cells in the central nervous system. Living with multiple sclerosis can be a
      difficult experience both physically and psychologically. Some of the most common symptoms
      for people with MS include excessive fatigue, limb weakness, motor abnormalities and sexual
      dysfunction with symptoms dependant on the central nervous system pathology. Multiple
      Sclerosis is the most common cause of disability in young to middle aged adults in the
      developing world. The relatively high incidence rates and longitudinal nature of the
      condition has a large economic impact on the health care system, people with Multiple
      Sclerosis and their families. Treatments are now able to better manage the condition but
      there is still no cure and the fundamental cause is still unknown, so symptom management and
      maintenance of function is crucial. Exercise and rehabilitation are increasingly being looked
      at to allow patients to better manage their condition and assist people with multiple
      sclerosis to self-manage their care.

      For many years people with multiple sclerosis have limited their activity levels to in order
      to not exasperate their symptoms. Since then research has shown that supervised exercise
      (aerobic and strength) training can be beneficial for people with mild to moderate multiple
      sclerosis. Current evidence now suggests that exercise may actually go even further than
      improving function and better managing symptoms in multiple sclerosis, but may actually have
      a disease modifying effect, suggesting that guidance for long-term prescription is
      imperative.

      High intensity interval training (HIIT) describes exercise that is characterised by short
      bursts of vigorous effort followed by periods of rest or low intensity exercise. High
      intensity interval trainingis an extremely variable mode of exercise with sessions altered by
      intensity, duration and number of intervals as well as the duration and activity chosen
      during the rest period. High intensity interval training has been shown to be an effective
      alternative to traditional endurance training so often used in exercise interventions. It has
      also been suggested that High intensity interval trainingis more enjoyable than moderate
      intensity exercise. These findings are important because lack of time and lack of enjoyment
      are two of the most commonly quoted barriers to regular activity.

      The project utilises a pre-experimental one-group pre-test - post-test design. The
      participants will be assessed at baseline, followed by an intervention and then measured
      again at follow up.Patients will be purposively recruited from the multiple sclerosis clinic
      at the Royal Hallamshire Hospital in Sheffield. Potential participants will be identified by
      consultant neurologists to the research assistant from clinic lists/patient records. Patients
      who satisfy the inclusion and exclusion criteria will be given/sent a recruitment letter and
      participant information sheet informing them about the study. The letter will contain a
      tear-off slip for patients to return to the research team indicating their interest or not in
      study participation. It will be clearly stated in the letter that there is no obligation or
      pressure to participate and that if patients are not interested their future medical care
      will not be jeopardised. Patients who respond to the letter of invitation will be invited
      into the Centre for Sport and Exercise Science for a consultation.

      Once a participant has been recruited and provided informed consent they will attend a
      baseline assessment. Each participant will undergo a VO2peak test on a cycle ergometer. Gas
      measurement will be conducted breath by breath by means of telemetric spirometry, heart rate
      will be measured by Polar system. The test will be conducted to volitional exhaustion or will
      be terminated when any of the following criteria are met:

        -  symptom exacerbation

        -  symptoms indicating risk for the safety or health of the patients

        -  plateau in oxygen uptake with increasing workload and/ or

        -  respiratory exchange rate greater than 1.15

      Three questionnaires will be administered to the participants to determine the effects of the
      exercise interventions on physical activity level (Godin Leisure Time Questionnaire), fatigue
      (modified fatigue impact scale), and health perception (SF-36). Participants will also be
      given an ActiGraph accelerometer to wear for 7-days. The procedures will be repeated at
      follow up by a blinded assessor.

      Participants will attend two sessions per week for the 6 week intervention. Each session will
      consist of 6-10 sets of 60 second high intensity intervals interspersed with 60 seconds
      recovery. The workload during each interval will be set at 80-90% of peak power achieved
      during the VO2peak test. This is predicted to elicit 85-95% heart rate reserve in the
      participants. After each interval the participant's heart rate and rate of perceived exertion
      (RPE) will be collected. After each session a researcher will complete an Adverse Event form
      to record if an event occurred or not. Additionally the participant will complete a physical
      activity enjoyment (Perceived activity enjoyment scale) after one session per week.

      Outcomes will be assessed at two-time-points: baseline and after the 6-week intervention.
      Personal characteristics (e.g. postcode, marital status ethnicity, etc.) and condition
      specific data (e.g. time since diagnosis, medication, onset of symptoms, use of health care
      resources etc.) will be collected.
    

Intervention name(s): High Intensity Interval Training
Intervention type(s): Other
Intervention description(s): High Intensity Interval Training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment