Tuesday, 9 July 2013

Exercise Trial for Canadian MSers

BACKGROUND: Despite the commonly known benefits of exercise and physical activity evidence shows that persons Multiple Sclerosis (MS) are relatively inactive yet physical activity may be even more important in a population facing functional deterioration. No exercise is effective if it is not done and people with MS face unique barriers to exercise engagement which need to be overcome. We have developed and pilot tested a Multiple Sclerosis Tailored Exercise Program (MSTEP) and it is ready to be tested against general guidelines for superiority and ultimately for its impact on MS relevant outcomes. The primary research question is to what extent does an MS Tailored Exercise Program (MSTEP) result in greater improvements in exercise capacity and related outcomes over a one year period in comparison to a program based on general guidelines for exercise among people with MS who are sedentary and wish to engage in exercise as part of MS self-management.

METHODS: The proposed study is an assessor-blind, parallel-group, randomized controlled trial (RCT). The duration of the intervention will be one year with follow-up to year two. The targeted outcomes are exercise capacity, functional ambulation, strength, and components of quality of life including frequency and intensity of fatigue symptoms, mood, global physical function, health perception, and objective measures of activity level. Logistic regression will be used to test the main hypothesis related to the superiority of the MSTEP program based on a greater proportion of people making a clinically relevant gain in exercise capacity at 1 year and at 2 years, using an intention-to-treat approach. Sample size will be 240 (120 per group).

DISCUSSION: The MS community is clearly looking for interventions to help alleviate the disabling sequelae of MS and promote health. Exercise is a well-known intervention which has known benefits to all, yet few exercise regularly. For people with MS, the role of exercise in MS management needs to be rigorously assessed to inform people as to how best to use exercise to reduce disability and promote health.Trial registration: NCT01611987.

Well I never, you say we don't do much none drug stuff and came across this paper. So first things first this is a trial on exercise. The MSTEP program is a 6 day tailored exercise program. It includes flexibility, aerobic, peripheral strengthening, core and balance training, power and speed training and push days. If you live in Canada and are interested search on the NCT number for details.

CoI. I have nothing to do with this trial and happy to give it a plug but this really is publication for old rope.

The following has no relevance to the people in the above paper it is just a general comment

So you plan to do a trial you publish it that you are going to do the trial, but tell us little else than you are doing a trial and here is your protocol, which is sort of on clinical trials if you have and NCT number. 

The paper gravy train for clinicians. 

The problem is for the clinicians doing the trial that takes years to do so they go to conferences and give it an interesting title and some poor Joe Schmo like me wastes half and hour of their life listening to the person telling us about the trial and then there are no results . I remember when the beta interferon trials were ongoing it was like this ......dull dull dull.

I suppose it gives a reference for people to cite. So we now have  journals of clinical trial protocols....are these worth the cyber paper they are written on?

I wonder if I can get a paper on my last grant...but no that has real ideas in it. How about I describe travel plans for getting to work.

So Pubmed are now advertising for trials. 
I guess a good way of stimulating recruitment. I wonder if Pubmed are charging BMC extra for this, BMC are charging £1290, $1985 €1515 publication charge.  

Hey ProfG Maybe we should do for the PROXIMUS trial.


  1. I am not convinced of the value of another exercise trial. There has just been one in the UK (http://www.ncbi.nlm.nih.gov/pubmed/23123791), albeit a shorter intervention. It was reported at Frontiers, and if I recall correctly it wasn't strongly positive. I.e. there were few differences between the groups that were sustained after the intervention.
    This isn't to say that exercise isn't good for everyone - it certainly is - regardless of MS or not.
    Sorry... cynical head on today!

  2. I thought MD2 may have something to say about papers for cliniians


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