Despite widespread beliefs about the benefits of FES cycling on urine output, lower limb swelling and spasticity, we were unable to detect a convincing treatment effect on any of these variables. However, our results cannot be interpreted as evidence of no treatment effect because this interpretation relies on defining a minimally worthwhile treatment effect and it is not clear what size treatment effect clinicians and people with spinal cord injury would consider sufficient to justify the time and cost associated with SB431542 clinical trial FES cycling. If people with spinal cord injury would consider a treatment effect equivalent

to 10% of mean initial values then our results could be used to indicate that FES cycling has no effect on lower limb swelling. Regardless, our results provide valuable data for future meta-analyses which may be the only way of answering questions about the effectiveness of FES cycling on these parameters in people with spinal

cord injury. Our results and protocol also provide useful information for future trials. Our point estimates of treatment effects for some variables were imprecise as reflected in the wide 95% CI associated with the between-group differences. This was particularly a problem for urine HKI-272 concentration output. To increase the precision of our point estimates we needed a larger sample size and/or tighter inclusion criteria. We tried to minimise the need for a large sample size by using a cross-over design. Our research question was appropriate

for a cross-over design because any effects of FES cycling on urine output are probably short lived. We could have tightened our inclusion criteria. Megestrol Acetate For example, those with AIS A lesions may respond better and more consistently to FES cycling than those with AIS B, C or D lesions because they tolerate higher levels of stimulation. However, by restricting the inclusion criteria we would have also restricted the ability to generalise the results to a broad population. Setting the inclusion criterion of clinical trials is always a balance between these competing considerations. There are no other studies investigating the effect of FES cycling on urine output against which to compare our results. At least one study provides indirect evidence to support the theory that FES cycling reduces swelling via its therapeutic effects on venous return. This study examined the effect of ES contractions on lower limb swelling during static standing on a tilt table in able-bodied individuals (Man et al 2003).