Objectives; to compare exercise plus social cognitive theory intervention with exercise plus contact control education intervention in inactive people with Multiple Sclerosis (PwMS).
Method; this was a multi-centre, double blind, randomised, controlled trial. People with minimal disability due to MS (Participant Determined Disease Steps ≤3) who were inactive and had no relapse or change in medications for 3 months completed an exercise intervention that aimed to bring them to the MS exercise guidelines. The 10 week tapered, individualised exercise intervention included aerobic and strengthening exercise delivered by physiotherapists in the community. The intervention group received exercise and structured education based on principles of social cognitive theory (SCT). The controls received the same exercise and didactic education unrelated to exercise. Main Outcome Measures were; Six Minute Walk Test (6MWT), Multiple Sclerosis Walking Scale-12 (MSWS-12), Multiple Sclerosis Impact Scale 29 (MSIS-29); Modified Fatigue Impact Scale (MFIS)
Results; Using linear mixed effects model, controlling for baseline values and clinical characteristics, the difference between groups on the primary measure (6MWT) at 6 month follow-up was not significant (p=0.25); the intervention group walked on average 23.2m further than the controls which reflects a clinically important difference in walking distance.
Using per protocol analysis (patients with at least 2 follow-up assessments) there was a significant treatment effect favouring the intervention group (p=0.038) mean difference in 6MWT 40.0m (95%CI 2.3 - 77.8) at 6 month follow-up. Both groups had significant change from baseline following the 10 week intervention in 6MWT (intervention mean=83.0 sd=60.1, control mean=56.9 sd=73.5), MFIS (intervention mean=-5.0 sd=12.1, control mean=-7.7 sd=11.7) MSIS-29 psychological (intervention mean=-7.5 sd=14.5, control mean=-4.2 sd=18.0), but were not statistically different at 6 month follow-up (p=0.25, 0.16, 0.35).
Conclusions; The exercise intervention enabled inactive PwMS to meet the MS exercise guidelines and resulted in significant improvements in a range of MS symptoms. Using per protocol analysis we found significant differences between control and SCT education groups for 6MWT at 6 month follow-up.
Ethics Approval; was granted by the Faculty of Education and Health Science Research Ethics Committee, University of Limerick (2014_02_20_EHS), in addition to the Research Ethics Committees at the University College Hospital Galway, University Hospital Limerick and Cork University Hospital.
