Can exercise reduce disability in peripheral neuropathy?

Completed

• Conditions: Guillain Barré syndrome (GBS), chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), paraproteinemic demyelinating neuropathy (PDN); Nervous System Diseases; Guillain-Barré syndrome

• Registration Number: ISRCTN13311697
• Lead Sponsor: King's College London (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26293925

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-06
• Study Completion: 2013-12-31
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Are adults with stable motor neuropathy with or without sensory neuropathy, as a result of GBS, CIDP or PDN diagnosed using established criteria (and where PDN is defined as the combination of a demyelinating neuropathy, serum antibodies to myelin associated glycoprotein, and an IgM monoclonal gammopathy with no evidence of haematological malignancy)
2. Are able to walk 10 metres, with or without walking aids
3. Are at least 1 year since onset if they have GBS
4. Have no change in self reported disability, immunotherapy or medication for neuropathic pain in the previous 6 months (except dose of azathioprine must not have changed for 12 months). Patients receiving regular intravenous immunoglobulin (IVIg) or plasma exchange will be assessed at the same time points after treatment to avoid fluctuations due to time since last treatment.

Exclusion Criteria

1. They score zero on the primary outcome measure
2. They have any other unstable medical conditions that
2.1. Affect activity limitation
2.2. Prevents them from exercising
2.3. Would make it unsafe to exercise
3. They are pregnant
4. Adults who are unable to consent for themselves
5. Are not able to understand spoken and/or written English or not able to communicate responses to questionnaires

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Overall neuropathy limitations score (ONLS)<br> 2. Rasch Overall Disability Scale (R-ODS) score<br><br> Measured at end of intervention (12 weeks) and 12 months.<br>

Secondary Outcome Measures

Name	Time	Method
<br> All secondary outcome measures except the client service receipt inventory (CSRI) are to be assessed at end of intervention and 12 month follow-up:<br><br> 1. Fatigue (Fatigue severity scale - FSS)<br> 2. Mood (Hospital anxiety and depression scale - HADS)<br> 3. Quality of life (medical outcomes short form 12 - SF12)<br> 4. Level of physical activity (International physical activity questionnaire - IPAQ)<br> 5. Health beliefs (brief illness perception questionnaire - IPQ)<br> 6. Self-efficacy (Self-efficacy for exercise scale - SSE)<br> 7. Adherence (Exercise adherence rating scale (EARS) modified version of Medication adherence rating scale)<br><br> The CSRI will be assessed at baseline and 12 month follow-up when cost utility (quality adjusted life years (QALYs) derived from Euroquol (EQ5D) will be evaluated.<br>