Comparison of the outcomes of home based and supervised individually designed exercise programme amongst the patients in chronic phase after guillain barre syndrome: study protocol for a randomized control trial
DOI:
https://doi.org/10.18203/2349-3259.ijct20180132Keywords:
Guillain barre syndrome, Superiority randomized control trial, PhysiotherapyAbstract
Background: Guillain barre syndrome (GBS) is an immune mediated polyneuropathy characterized by progressive weakness and variety of symptoms including muscle paralysis, autonomic dysfunction and respiratory involvement that affect one or two persons in 100,000 population. Although immunotherapies including therapeutic plasma exchange (TPE), immunoglobulins (IVIg) and corticosteroids are the available beneficial modes of treatment, the residual symptoms are disabling and long lasting and require long term rehabilitation. Observational studies and RCT on multi-disciplinary care has proven exercises to be an answer to residual long lasting disability. Supervised individually designed exercise prescription after physiotherapy assessment may play a major role in minimizing disability.
Methods: The present study is an open-level, parallel, superiority randomized control trial with blinding of outcome assessors to evaluate the results of the individually designed exercise programme over home based exercise programme. 74 adult referred GBS patients will be recruited and randomize in two groups either to receive 12 weeks individually designed exercise programme or home based exercise programme. The primary outcome shall be assessed as functional independence in activities of daily living and secondary outcomes shall be evaluated in terms of muscle strength, fatigue, pain, and quality of life at baseline, six months and twelve months duration.
Conclusions: This is the first randomized control trial to compare the effect of supervised individually designed exercise over home based exercise programme on pwGBS.
Trial registration: Currently the trial is ethically approved, prospectively registered CTRI/2016/08/007150 and in the process of recruiting its first subjects.
References
Khan F, Ng L, Amatya B, Brand C, Turner-Stokes L. Multidisciplinary care for Guillain-Barré syndrome. Cochrane Database Syst Rev. 2010;(10):CD008505.
Burns TM. Guillain-Barré syndrome. Semin Neurol. 2008 Apr;28(2):152–67.
Kalita J, Misra UK, Goyal G, Das M. Guillain-Barré syndrome: subtypes and predictors of outcome from India. J Peripher Nerv Syst. 2014;19(1):36–43.
Sharma G, Sood S, Sharma S. Seasonal, Age & Gender Variation of Guillain Barre Syndrome in a Tertiary Referral Center in India. Neurosci Med. 2013;4:23.
Forsberg A, Press R, Einarsson U, de Pedro-Cuesta J, Holmqvist LW. Disability and health-related quality of life in Guillain-Barré syndrome during the first two years after onset: a prospective study. Clin Rehabil. 2005;19(8):900–9.
Darweesh SKL, Polinder S, Mulder MJHL, Baena CP, van Leeuwen N, Franco OH, et al. Health-related quality of life in Guillain-Barré syndrome patients: a systematic review. J Peripher Nerv Syst JPNS. 2014;19(1):24–35.
Dhadke SV, Dhadke VN, Bangar SS, Korade MB. Clinical Profile of Guillain Barre Syndrome. J Asso Physicians India. 2013;61:168–72.
Sriganesh K, Netto A, Kulkarni GB, Taly AB, Umamaheswara Rao GS. Seasonal variation in the clinical recovery of patients with Guillain Barré syndrome requiring mechanical ventilation. Neurol India. 2013;61(4):349–54.
van Doorn PA, Ruts L, Jacobs BC. Clinical features, pathogenesis, and treatment of Guillain-Barré syndrome. Lancet Neurol. 2008;7(10):939–50.
Hughes RA, Swan AV, Raphaël J-C, Annane D, van Koningsveld R, van Doorn PA. Immunotherapy for Guillain-Barré syndrome: a systematic review. Brain. 2007;130(9):2245–57.
Hughes RA, Wijdicks EF, Benson E, Cornblath DR, Hahn AF, Meythaler JM, et al. Supportive care for patients with Guillain-Barré syndrome. Arch Neurol. 2005;62(8):1194–8.
Forsberg A, Press R, Einarsson U, de Pedro-Cuesta J, Holmqvist LW. Disability and health-related quality of life in Guillain-Barré syndrome during the first two years after onset: a prospective study. Clin Rehabil. 2005;19(8):900–9.
Khan F, Ng L, Amatya B, Brand C, Turner-Stokes L. Multidisciplinary care for Guillain-Barré syndrome. Eur J Phys Rehabil Med. 2011;47(4):607–12.
Forsberg A, Press R, Holmqvist LW. Residual disability 10years after falling ill in Guillain–Barré syndrome: A prospective follow-up study. J Neurol Sci. 2012;317(1):74–9.
De Vries JM, Hagemans MLC, Bussmann JBJ, Van der Ploeg AT, Van Doorn PA. Fatigue in neuromuscular disorders: focus on Guillain–Barré syndrome and Pompe disease. Cell Mol Life Sci. 2010;67(5):701–713.
Rekand T, Gramstad A, Vedeler CA. Fatigue, pain and muscle weakness are frequent after Guillain-Barré syndrome and poliomyelitis. J Neurol. 2009;256(3):349–54.
Merkies ISJ, Schmitz PIM, Samijn JPA, Van Der Meché FGA, Van Doorn PA, others. Fatigue in immune-mediated polyneuropathies. Neurology. 1999;53(8):1648–48.
Chaudhuri A, Behan PO. Fatigue in neurological disorders. The Lancet. 2004;363(9413):978–88.
White CM, Pritchard J, Turner-Stokes L. Exercise for people with peripheral neuropathy. Cochrane Database Syst Rev. 2004;(4):CD003904.
Garssen MPJ, Bussmann JBJ, Schmitz PIM, Zandbergen A, Welter TG, Merkies ISJ, et al. Physical training and fatigue, fitness, and quality of life in Guillain-Barré syndrome and CIDP. Neurology. 2004;63(12):2393–5.
Dumoulin C, Hay-Smith J, Habée-Séguin GM, Mercier J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: A short version Cochrane systematic review with meta-analysis. Neurourol Urodyn. 2015;34(4):300-8.
El Mhandi L, Calmels P, Camdessanché JP, Gautheron V, Féasson L. Muscle strength recovery in treated Guillain-Barré syndrome: a prospective study for the first 18 months after onset. Am J Phys Med Rehabil. 2007;86(9):716–24.
Graham RC, Hughes RAC, White CM. A prospective study of physiotherapist prescribed community based exercise in inflammatory peripheral neuropathy. J Neurol. 2007;254(2):228–35.
Hughes RAC, Wijdicks EFM, Benson E, Cornblath DR, Hahn AF, Meythaler JM, et al. Supportive care for patients with Guillain-Barré syndrome. Arch Neurol. 2005;62(8):1194–8.
Nehal S, Manisha S. Role of Physiotherapy in Guillain Barre Syndrome: A Narrative Review. Int J Health Sci Res IJHSR. 2015;5(9):529–40.
Orsini M, de Freitas MRG, Presto B, Mello MP, Reis CHM, Silveira V, et al. Guideline for Neuromuscular Rehabilitation in Guillain-Barré Syndrome: What can we do. Study Performed Neuromuscul Dis Outpatient -Vision–Federal Flum Univ Antônio Pe-Dro Univ Hosp-RJ Braz. 2010;2.
Khan F, Amatya B. Rehabilitation interventions in patients with acute demyelinating inflammatory polyneuropathy: a systematic review. Eur J Phys Rehabil Med. 2012;48(3):507–22.
Khan F, Pallant JF, Amatya B, Ng L, Gorelik A, Brand C. Outcomes of high- and low-intensity rehabilitation programme for persons in chronic phase after Guillain-Barré syndrome: a randomized controlled trial. J Rehabil Med. 2011;43(7):638–46.
Craig J, Young CA, Ennis M, Baker G, Boggild M. A randomised controlled trial comparing rehabilitation against standard therapy in multiple sclerosis patients receiving intravenous steroid treatment. J Neurol Neurosurg Psychiatry. 2003;74(9):1225–30.
OpenEpi - Toolkit Shell for Developing New Applications. Available at: http://www.openepi. com/SampleSize/SSMean.htm. Accessed on 16 December 2016.
Khan F, Pallant JF. Use of the International Classification of Functioning, Disability and Health to identify preliminary comprehensive and brief core sets for Guillain Barre syndrome. Disabil Rehabil. 2011;33(15–16):1306–13.
WHO | International Classification of Functioning, Disability and Health (ICF). WHO. Available at: http://www.who.int/classifications/icf/en/. Accessed on 16 December 2016.
Pitetti KH, Barrett PJ, Abbas D. Endurance exercise training in Guillain-Barré syndrome. Arch Phys Med Rehabil. 1993;(74):761–5.
Karper WB. Effects of low-intensity aerobic exercise on one subject with chronic-relapsing Guillain-Barré syndrome. Rehabil Nurs. 1991;16(2):96–8.
Meneses-Echávez JF, Ramírez-Vélez R, González-Jiménez E. Effects of supervised exercise on cancer-related fatigue in breast cancer survivors: a systematic review and meta-analysis. BMC Cancer. 2015;15(1):1069.
Mulero P, Almansa R, Neri MJ, Bermejo-Martin JF, Archanco M, Arenillas JF, et al. Improvement of fatigue in multiple sclerosis by physical exercise is associated to modulation of systemic interferon response. J Neuroimmunol. 2015 Mar 15;280:8–11.
Peña L, Moreno CB, Gutierrez-Alvarez AM. Pain management in Guillain-Barre syndrome: A systematic review. Neurol Barc Spain. 2015;30(7):433-8.
Khan F. Rehabilitation in Guillian Barre syndrome. Aust Fam Physician. 2004;33(12):1013–7.
Meythaler JM. Rehabilitation of Guillain-Barré syndrome. Arch Phys Med Rehabil. 1997;78(8):872–9.
Mullings KR, Alleva JT, Hudgins TH. Rehabilitation of Guillain-Barré syndrome. Dis--Mon DM. 2010;56(5):288–92.
McDowell I. Measuring health: a guide to rating scales and questionnaires. Oxford university press; 2006. Available at: https://books.google.co.in/books Accessed on 17 December 2016.
Mahoney FI, Barthel DW. Functional Evaluation: The Barthel Index. Md State Med J. 1965;14:61–5.
Merkies ISJ, Schmitz PIM, Van der Meché FGA, Samijn JPA, Van Doorn PA. Connecting impairment, disability, and handicap in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry. 2003;74(1):99–104.
MRC Muscle scale - Our research - Medical Research Council. Available at: https://www.mrc.ac. uk/research/facilities-and-resources-for-researchers/ mrc-scales/mrc-muscle-scale/. Accessed on 16 May 2017.
Compston A. Aids to the investigation of peripheral nerve injuries. Medical Research Council: Nerve Injuries Research Committee. His Majesty’s Stationery Office: 1942; pp. 48 (iii) and 74 figures and 7 diagrams; with aids to the examination of the peripheral nervous system. By Michael O’Brien for the Guarantors of Brain. Saunders Elsevier: 2010; pp.[8] 64 and 94 Figures. Brain. 2010;133(10):2838–44.
WHO. WHO Quality of Life-BREF (WHOQOL-BREF). WHO. Available at: http://www.who.int/ substance_abuse/research_tools/whoqolbref/en/. Accessed on 26 May 2017.
White CM, Hadden RD, Robert-Lewis SF, McCrone PR, Petty JL. Observer blind randomised controlled trial of a tailored home exercise programme versus usual care in people with stable inflammatory immune mediated neuropathy. BMC Neurol. 2015;15(1):147.
