Abstract
BackgroundMost patients who suffer a stroke experience reduced walking competency and health-related quality of life (HRQoL). A key factor in effective stroke rehabilitation is intensive, task-specific training. Recent studies suggest that intensive, patient-tailored training can be organized as a circuit with a series of task-oriented workstations.Primary aim of the FIT-Stroke trial is to evaluate the effects and cost-effectiveness of a structured, progressive task-oriented circuit class training (CCT) programme, compared to usual physiotherapeutic care during outpatient rehabilitation in a rehabilitation centre. The task-oriented CCT will be applied in groups of 4 to 6 patients. Outcome will be defined in terms of gait and gait-related ADLs after stroke. The trial will also investigate the generalizability of treatment effects of task-oriented CCT in terms of perceived fatigue, anxiety, depression and perceived HRQoL.Methods/designThe multicentre single-blinded randomized trial will include 220 stroke patients discharged to the community from inpatient rehabilitation, who are able to communicate and walk at least 10 m without physical, hands-on assistance. After discharge from inpatient rehabilitation, patients in the experimental group will receive task-oriented CCT two times a week for 12 weeks at the physiotherapy department of the rehabilitation centre. Control group patients will receive usual individual, face-to-face, physiotherapy. Costs will be evaluated by having each patient keep a cost diary for the first 24 weeks after randomisation. Primary outcomes are the mobility part of the Stroke Impact Scale (SIS-3.0) and the EuroQol. Secondary outcomes are the other domains of SIS-3.0, lower limb muscle strength, walking endurance, gait speed, balance, confidence not to fall, instrumental ADL, fatigue, anxiety, depression and HRQoL.DiscussionBased on assumptions about the effect of intensity of practice and specificity of treatment effects, FIT-Stroke will address two key aims. The first aim is to investigate the effects of task-oriented CCT on walking competency and HRQoL compared to usual face-to-face physiotherapy. The second aim is to reveal the cost-effectiveness of task-oriented CCT in the first 6 months post stroke. Both aims were recently recommended as priorities by the American Hearth Association and Stroke Council.Trial registrationThis study is registered in the Dutch Trial Register as NTR1534.
Highlights
Most patients who suffer a stroke experience reduced walking competency and health-related quality of life (HRQoL)
The first aim is to investigate the effects of task-oriented circuit class training (CCT) on walking competency and HRQoL compared to usual face-to-face physiotherapy
Circuit class training allows staff-topatient ratios to be lower than they are in individual physiotherapy and enables a group of patients to exercise at Walking competence is defined as 'the ability to perform gait and gait-related tasks successfully', with gait-related activities defined as activities involving mobility-related tasks such as stair walking, turning, making transfers, walking quickly and walking specified distances'[18]
Summary
The FIT-Stroke trial is a single-blinded multicentre trial in which 220 patients will be allocated to task-oriented CCT or usual face-to-face treatment at the nine participating rehabilitation centres, on the basis of a minimization procedure. In order to fill this gap in existing evidence, the FIT-Stroke trial will have a follow-up of three months to investigate the possible wash-out effects of the task-oriented CCT programme. One study[60] included in the meta-analysis investigated the effects of task-oriented CCT within the first 6 months post stroke. None of the included studies compared the costeffectiveness of task-oriented CCT with that of usual care, which is important in view of the burden of health care costs for stroke and attempts to save costs in stroke management This aim is in line with the views of http://www.biomedcentral.com/1471-2377/9/43 the American Hearth Association (AHA), which recently recommended that fundraisers and researchers should conduct cost-effectiveness studies in the growing and ageing stroke population[8]. The first results of the study are expected in August 2011
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