The Sheffield ExIMS trial
The effects of a pragmatic exercise intervention in people with multiple
sclerosis
Exercise is increasingly being accepted as a component of symptom
management in people with multiple sclerosis. High quality research exists
to support the benefits of exercise on physical function, muscle power,
exercise tolerance, quality of life and mobility-related activities in people
with MS. Previous research also suggests that exercise intervention has the
potential to improve the mental wellbeing of people with MS.
The aim of the study is to investigate whether a practically designed
exercise programme is effective for providing improvements in physical
activity and health outcomes which are likely to have a positive impact on
physical function and quality of life in people with MS. The study will also
explore what amounts of exercise are most effective and whether exercise
is more or less beneficial for people with MS with different disability levels.
The study also aims to see if the addition of a pragmatic exercise therapy
intervention in people with multiple sclerosis is a more cost-effective
treatment than current medical care alone.
Recruitment dates
Start: February 2009
End: January 2012
Phase
Phase III
Who can enter the trial?
You can take part in this trial if you live within Sheffield or the South
Yorkshire region and have received or currently receive treatment for MS in
Sheffield. In addition, you must:
• Be aged 18-65 years
• Have a clinical diagnosis of MS with an EDSS score of between 1.0-6.5, and
are able to walk 10m distance
• Have been clinically stable for at least 4 weeks prior to entering the study
• Be physically able to participate in some form of exercise three times per
week
• Be able to provide written informed consent
N.B. If you are taking disease modifying therapy (interferon and glatiramer
acetate), you must have been stable on this treatment for at least 3 months
prior to entering the study.
Participation in this study is entirely voluntary. If people with MS decide not
to take part, this will not affect the standard of care they receive from the
hospital or any health professional. Participants are also free to withdraw
from the study at any time without it affecting their future treatment
Exclusion Criteria
You cannot take part in this study if you:
• Fail to meet any of the above inclusion criteria
• Are experiencing illness that impairs your ability to be physically active
three times per week
• Are not willing to be randomised to either the exercise intervention or
usual care control group
• Live more than 20 miles from the trial centre
• Are already engaged in purposeful structured exercise or brisk walking
exercise 3 times or more per week for 30 min or more per session and have
been on a consistent basis for the previous 6-months
Trial design
This is a randomised controlled trial with participants being grouped
according to gender and EDSS score (low: up to 3.5, high: up to 6.5).
The study aims to recruit 120 people with MS over 24-months and people
will be randomly allocated to either an exercise or usual care group. The
randomisation is generated by a computer sequence, in order to make sure
the results are scientific.
The exercise intervention will last 12 weeks. The study will monitor
people’s progress throughout, to make sure that the exercise programme
progresses at an appropriate rate. Participants will then be assessed 6
months after the end of the intervention to see if it has had a more long
term impact.
The process
Initial appointment:
Those people interested in entering the study will be initially invited to
attend an appointment with the study researcher at The Centre for Sport
and Exercise Science at Sheffield Hallam University. Participants will have
the opportunity to go through the patient information sheet and ask any
questions they might have about the study and will also be shown around
the exercise training facility and assessment room and taken through the
procedures. A consent form will be given to participants to take home and
complete so that they can have time to decide whether or not they would
like to take part in the study.
Assessment:
Those who decide to take part will be asked to attend the University for an
initial assessment session before being randomised to either the exercise
intervention or the usual care group. Participants should bring their
completed consent form to the first session. People will be assessed on a
total of three occasions; at the start of the programme, immediately
following the 12 week intervention and six months following the
intervention. In addition, at the end of the supervised exercise sessions
some individuals will be randomly chosen to participate in a one-to-one
interview and focus group sessions at the University to discuss their
experiences of the research study.
At the University:
During the assessment session a small blood sample and complete series of
functional and physical tests will be taken. These include measurement of
resting heart rate and blood pressure, height, weight and waist: hip girths,
completion of the MS Functional composite test (25 ft walk, nine hole peg
test and paced auditory serial addition test) and a six minute walk test.
These visits should last no more than 45 minutes.
At Home:
Participants will also be asked to complete a self assessment questionnaire.
This can be completed at home and will include measures of physical
activity behaviour, quality of life, fatigue and cost effectiveness. This
should take no longer than one hour to complete. Participants will also be
asked to wear an accelerometer (a small device worn like a pedometer) for
a seven day period and keep a physical activity recall diary during this
period. In addition, salivary cortisol will be measured on three consecutive
days at four different times. A special watch will be provided to help people
remember.
At the Hospital:
Participants will also be required to have an appointment with a consultant
at the Royal Hallamshire Hospital to assess their disability score (EDSS). This
appointment should take no more than 30 minutes.
How many times (and how often) they have treatment
After the baseline assessment sessions, participants allocated to the
exercise intervention group will be asked to participate in three exercise
sessions a week over a 12 week period. For the first six weeks this will
consist of two supervised exercise sessions and one exercise session at
home. In the second six weeks people will be asked to complete one
supervised exercise session a week and two exercise sessions at home.
Supervised sessions will take place at The Centre for Sport and Exercise
Science at Sheffield Hallam University, Collegiate Crescent Campus and are
lead by experienced exercise professionals, with programmes overseen by
the project physiotherapist.
Supervised exercise will take place in small groups (up to three to four
people) and will begin with a gentle warm up. Each exercise session will
take 45-60 minutes and will consist of completing short bouts of exercise (15 minutes), with rest intervals, at a low-moderate intensity. Where
appropriate, strength, balance and flexibility work may also be performed.
Heart rate, ratings of perceived exertion and minutes of specific exercises
achieved will be recorded by the researcher to allow for an assessment of
the exercise dose achieved each week. All exercise sessions are tailored to
each individual’s level of ability, according to their symptoms, fitness and
personal goals.
Those people allocated to the usual care group will be asked to continue
with their usual daily routine. They will only be required to attend the
Centre to complete the assessments (outlined previously), which will be at
the beginning, after a further 12-weeks, and after a further six months.
Side effects
People who haven’t exercised for a while might initially feel that they are
breathing harder than usual or will feel slightly sweaty. Exercise may also
initially make one feel tired, but as it is done more regularly this should feel
increasingly better.
Location of the trial
The Centre for Sport and Exercise Science at Sheffield Hallam University
Project Co-ordinator
Dr. John Saxton
Supported by
The MS Society
The Centre for Sport and Exercise Science, Sheffield Hallam University
Sheffield Teaching Hospitals NHS Foundation Trust
Contact details
If you are interested in taking part in this study please discuss this
information with your neurologist or GP.