Exercise therapy and cognitive behavioural therapy to improve fatigue, daily activity performance and quality of life in Postpoliomyelitis Syndrome: the protocol of the

Background: Postpoliom yelitis Syndrom e (PPS) is a com p lex o f late onset neurom uscu lar sym ptom s w ith new or increased m uscle w eakness and m uscle fatigab ility as key sym ptom s. Main clin ical com p la ints are severe fatigue, deterioration in functional ab ilities and health related quality o f life. Rehabilitation m anagem ent is the m ainstay o f treatm ent. Tw o different therapeutic in terventions m ay be prescribed (1) exercise therapy or (2) cogn itive behavioural therapy (CBT). H ow ever, the ev idence on the effectiveness o f both in terventions is lim ited . The prim ary aim o f the FACTS-2-PPS trial is to study the efficacy o f exercise therapy and CBT for reducing fatigue and im proving activ ities and quality o f life in patients w ith PPS. Add itionally , the working m echan ism s, patients' and therap ists' expectations o f and experiences w ith both in terventions and costeffectiveness w ill be eva luated . M ethods/Design: A m ulti-centre , s ing le-b linded , random ized contro lled trial w ill be co nducted . A sam ple o f 81 severe ly fatigued patients w ith PPS w ill be recru ited from 3 d ifferent un iversity hosp itals and the ir affiliate rehab ilitation centres. Patients w ill be random ized to one o f th ree groups i.e. (1) exercise therap y + usual care, (2) CBT + usual care, (3) usual care. A t base line , im m ed iate ly post-in tervention and at 3and 6m onths fo llow -up , fatigue , activ ities, qua lity o f life and secondary ou tcom es w ill be assessed. Costs w ill be based on a cost q uestionnaire , and statistical analyses on GEE (generalized estim ated equations). A nalysis w ill also co nsider m echan ism s o f chang e during therapy. A responsive eva luation w ill be conducted to m on ito r the im p lem entation process and to investigate the persp ectives o f patients and therap ists on both in terventions. Discussion: A m ajor strength o f the FACTS-2-PPS study is the use o f a m ixed m ethods design in w h ich a responsive and econom ic evaluation runs parallel to the trial. The results o f this study will generate new evidence for the rehabilitation treatm ent o f persons w ith PPS. Trial registration: Dutch Trial Register NTR1371. * Correspondence: [email protected] department of Rehabilitation, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands FACTS-2-PPS trial Fieke S Ko o pm an1*, Anita Beelen1, Karin H Gerrits2, Gijs Bleijenberg3, Tineke A A b m a4, Marianne de Visser5, Frans Nollet1 B io Med Central © 2010 Koopm an et al; licensee BioMed Central Ltd. This is an O pen A ccess article distributed under the term s of the Creative C o m m o n s Attribution License (http://creativecom m ons.org/licenses/by/2.0), w hich perm its unrestricted use, distribution, and reproduction in any m edium , provided the original w ork is properly cited. Koopm an et al. BMC Neurology 2010, 10:8 http://www.biomedcentral.com/1471-2377/1078 Page 2 of 10