Extract

Background and study aims Many people with inflammatory immune mediated neuropathies (IN) experience long term activity limitation (or disability) and may need health and social services as well as informal care from family or friends. Long term management varies but observational studies suggest that exercise may improve activity limitation. The aim of this study is to establish the efficacy and cost effectiveness of a tailored home exercise programme (tHEP) in 54 people with stable inflammatory neuropathy compared to information and usual care only. Who can participate? Adults with a diagnosis of Guillain Barré syndrome (GBS), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) or paraproteinemic demyelinating neuropathy (PDN) who have had no changes in their symptoms or treatment in the last six months. Participants should also be able to walk at least 10 metres, with or without walking aids. What does the study involve? Participants will be randomised to either the tailored exercise group or the advice group. Participants in the advice group will receive information about exercise and usual care. Participants in the tailored exercise group will have an assessment with a physiotherapist who will prescribe an exercise regime based on their specific requirements and preferences, incorporating aerobic and strengthening exercise. Participants will complete questionnaires measuring fatigue, strength, endurance, mood, health beliefs, and quality of life at baseline, after 12 weeks and then after 12 months. Demographic data and information regarding service use, informal care and health status will also be collected and used to evaluate cost effectiveness of the intervention. Some participants will be invited to take part in semi-structured interviews to investigate the acceptability of the tailored home exercise programme (tHEP) and factors affecting adherence to it. What are the possible benefits and risks of participating? Participants will be observed undertaking exercise. In addition participants undertaking exercise who have residual weakness or sensory loss that places specific joints at biomechanical risk of injury or imbalance, will be referred for orthotic prescription prior to exercise. The burden on participants will differ between intervention and usual care groups. However, all participants will experience the burden of the time demand in completing study questionnaires. Where is the study run from? The study is taking place at various NHS hospitals across the UK, primarily in the South East and West Midlands. When is the study starting and how long is it expected to run for? The study is expected to start recruiting in September 2012 and recruitment will close in December 2013. Who is funding the study? Guillain Barré Syndrome Support Group, grant ref: GBS2011/8 Who is the main contact? Dr Jane Petty [email protected]

Inclusion criteria

• Guillain Barré syndrome (GBS), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), paraproteinemic demyelinating neuropathy (PDN)

Links

• ictrp
• isrctn