Maximising abilities, negotiating and generating exercise options (manage) program: a pilot randomised controlled trial in persons with multiple sclerosis

Abstract

Background: Persons with Multiple sclerosis (MS) often require therapy on a long-term basis, to maintain or improve their MS symptoms. The role of self management is increasingly being accepted as an effective way to improve outcomes in people with chronic conditions such as MS. A model of care that included this within a group environment could be a more effective and economical management option than traditional individual based care. Purpose: To determine the safety and feasibility of a self management community program in persons with MS. Secondary aims were to describe trends associated with the program on mobility, balance, fatigue, pain, quality of life, and perception of benefits and barriers to exercise. Methods: Single site, pilot randomised controlled trial (RCT). Twenty-three participants (43% male), mean age 48.6 (11.7) years with MS living in the community were randomly allocated to an intervention (n = 12) or control group (n = 11). The intervention group received twice weekly exercise and education for six weeks followed by assisted integration into a community exercise program. Outcome measures (adverse safety events, pain, fatigue, adherence, 10 metre walk test, 6-minute walk test, Functional Reach, Fatigue Severity Scale, Multiple Sclerosis Impact Scale and Exercise Benefits/Barriers Scale) were assessed at baseline, 6 weeks, 12 weeks and 24 weeks by a blinded assessor. Results: High adherence rates were achieved for attendance of the education (79%; 57 of 72 planned) and exercise (76%; 128 of 168 planned) sessions. No adverse safety events occurred. Significant differences were observed in the Multiple Sclerosis Impact Scale–Physical subscale (p = 0.016) and Visual Analogue Scale (VAS) fatigue (p = 0.017) between groups over time in favour of the intervention group. Within the intervention group significant improvements were seen from baseline to 6 weeks in the Functional Reach (p = 0.014), 6-minute walk test (p = 0.044), Fatigue Severity Scale (p = 0.034) and VAS pain (p = 0.034); and from baseline to 12 weeks in the Functional Reach (p = 0.023). There were no significant differences observed with the addition of the 24 week data. Conclusion(s): The MANAGE program, comprising of education, exercise and community integration in a group setting for persons with MS, appears safe and feasible. The initial findings of improvements in quality of life, pain, endurance, balance and fatigue levels in this small cohort are promising. Further research with a larger, adequately powered, RCT is needed to substantiate these findings. Future research considering the cost effectiveness of the MANAGE program in comparison with traditional individual therapy would also be beneficial. Implications: The use of this model of care for persons with MS could be an effective adjunct or potential alternative to current individual therapy approaches. The group format may result in greater efficiencies within service delivery. The self management approach is patient centred and goal focussed, which are critical components for long-term management of chronic diseases such as MS. This model may be of benefit to other chronic disease populations.