Observer blind randomised controlled trial of a tailored home exercise programme versus usual care in people with stable inflammatory immune mediated neuropathy

BACKGROUND: Inflammatory neuropathies such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy and paraproteinaemic demyelinating neuropathy are a heterogenous group of peripheral nerve disorders that affect around one to two people per 100,000. Whilst treatments such as intravenous immunoglobulin, plasma exchange and corticosteroids have generally positive results, long-term residual symptoms and associated activity limitations are common. There is currently no standardised care for patients with ongoing activity limitation and participation restriction as a result of inflammatory neuropathy IN but data from observational studies and a randomised controlled trial suggest that exercise either alone or as part of a multidisciplinary rehabilitation programme may be beneficial in improving activity limitation. Tailoring the intervention for participants following physiotherapy assessment and incorporating patient preference for type and location of exercise may be important. METHODS/DESIGN: The current study is a pragmatic, prospective, parallel observer-blind, randomised controlled trial to evaluate the efficacy and cost-effectiveness of a twelve week tailored home exercise programme versus advice and usual care. Seventy adults with stable immune mediated inflammatory neuropathy IN will be recruited to the study from two main sources: patients attending selected specialist peripheral nerve clinics in the South East and West Midlands of England and people with who access the GAIN charity website or newsletter. Participants will be randomised to receive either advice about exercise and usual care or a 12 week tailored home exercise programme. The primary outcome of activity limitation and secondary outcomes of fatigue, quality of life, self-efficacy, illness beliefs, mood and physical activity will be assessed via self-report questionnaire at baseline, 12 weeks and 12 months post intervention. Cost effectiveness and cost utility will be assessed via interview at baseline and 12 months post intervention. Intention to treat analysis will be our primary model for efficacy analysis. Semi-structured interviews will be conducted with a selected sample of participants in order to explore the acceptability of the intervention and factors affecting adherence to the exercise programme. DISCUSSION: This is the first randomised controlled trial to compare the efficacy and cost-effectiveness of tailored home exercise with advice about exercise and usual care for adults with inflammatory neuropathy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13311697