Exercise therapy and cognitive behavioural therapy to improve fatigue, daily activity performance and quality of life in postpoliomyelitis syndrome: the protocol of the FACTS-2-PPS trial.
BACKGROUND
Postpoliomyelitis Syndrome (PPS) is a complex of late onset neuromuscular symptoms with new or increased muscle weakness and muscle fatigability as key symptoms. Main clinical complaints are severe fatigue, deterioration in functional abilities and health related quality of life. Rehabilitation management is the mainstay of treatment. Two different therapeutic interventions may be prescribed (1) exercise therapy or (2) cognitive behavioural therapy (CBT). However, the evidence on the effectiveness of both interventions is limited. The primary aim of the FACTS-2-PPS trial is to study the efficacy of exercise therapy and CBT for reducing fatigue and improving activities and quality of life in patients with PPS. Additionally, the working mechanisms, patients' and therapists' expectations of and experiences with both interventions and cost-effectiveness will be evaluated.


METHODS
A multi-centre, single-blinded, randomized controlled trial will be conducted. A sample of 81 severely fatigued patients with PPS will be recruited from 3 different university hospitals and their affiliate rehabilitation centres. Patients will be randomized to one of three groups i.e. (1) exercise therapy + usual care, (2) CBT + usual care, (3) usual care. At baseline, immediately post-intervention and at 3- and 6-months follow-up, fatigue, activities, quality of life and secondary outcomes will be assessed. Costs will be based on a cost questionnaire, and statistical analyses on GEE (generalized estimated equations). Analysis will also consider mechanisms of change during therapy. A responsive evaluation will be conducted to monitor the implementation process and to investigate the perspectives of patients and therapists on both interventions.


CONCLUSIONS
A major strength of the FACTS-2-PPS study is the use of a mixed methods design in which a responsive and economic evaluation runs parallel to the trial. The results of this study will generate new evidence for the rehabilitation treatment of persons with PPS.


BACKGROUND
Dutch Trial Register NTR1371.
Koopman
Fieke S
FS
Department of Rehabilitation, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. S.Koopman@amc.uva.nl
Beelen
Anita
A
Gerrits
Karin H
KH
Bleijenberg
Gijs
G
Abma
Tineke A
TA
de Visser
Marianne
M
Nollet
Frans
F
D000203:Activities of Daily Living; D002319:Cardiovascular System / Q000503:physiopathology; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D005080:Exercise Test; D005081:Exercise Therapy / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D005221:Fatigue / Q000628:therapy; D005500:Follow-Up Studies; D006801:Humans; D009119:Muscle Contraction; D018482:Muscle, Skeletal / Q000503:physiopathology; D009426:Netherlands; D016262:Postpoliomyelitis Syndrome / Q000191:economics / Q000503:physiopathology / Q000534:rehabilitation*; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D016896:Treatment Outcome