Kwakkel 2008.
Study characteristics | ||
Methods | Study design: RCT Method of randomisation: "Participants were stratified by rehabilitation centre, and randomisation took place using an 'online' minimisation procedure" |
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Participants | Number of participants: n = 250 Inclusion criteria: verified stroke according to the WHO definition, able to walk a minimum of 10 m without physical assistance (functional ambulation categories ≥ three), discharged home from a rehabilitation centre, needed to continue physiotherapy during outpatient care to improve walking competency or physical condition, or both, able to give informed consent and be motivated to participate in a 12‐week intensive programme of physiotherapy Exclusion criteria: cognitive deficits as evaluated by the mini‐mental state examination (< 24 points), unable to communicate (< four points on the Utrechts Communicatie Onderzoek, UCO) and lived farther than 30 km from the rehabilitation centre |
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Interventions | (1) Circuit training (n = 126) "Graded task oriented circuit training programme (‘warming up (5 minutes), circuit training (60 minutes), evaluation and a short break (10 minutes), and group game (15 minutes)’) twice a week over a 12 week period (24 sessions)" "Training included eight different workstations, intended to improve meaningful tasks relating to walking competency" The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as comprising functional task training and musculoskeletal intervention (active) Length of intervention period: 12 weeks Number of sessions and length of individual sessions: "90 minute session twice a week (24 sessions). The circuit training group received 4461 treatment sessions, average treatment time per session was 72 (SD 39) minutes" Intervention provider: physiotherapist and sports therapist (2) Usual physiotherapy (n = 124) "Patients allocated to the control group received usual outpatient physiotherapy, mainly one to one treatments tailored to the patient with a physiotherapist who had not been on the circuit training course at one of the participating rehabilitation centres. Sessions designed to improve control of standing balance, physical condition, and walking competency were provided according to Dutch physiotherapy guidelines" The individual components delivered are listed in Table 6. Based on the individual components, this intervention is categorised as comprising usual care (cardiopulmonary intervention, functional task training and musculoskeletal intervention (active)) Length of intervention period: not stated Number of sessions and length of individual sessions: "no additional restrictions with respect to content, time, or duration of the physiotherapy. The group received 4378 with an average of 34 (SD 10) minutes per session" Intervention provider: physiotherapist This study is classified as intervention (functional task training, musculoskeletal (active)) versus usual care (functional task training, musculoskeletal (active)) (Table 8). Both groups received cardiopulmonary intervention |
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Outcomes | Measures of motor function: Rivermead Mobility Index (RMI) Measures of postural control and balance: timed balance test, Timed Up and Go, modified stairs test Measures of voluntary movements: Six‐Minute Walk test, five‐metre comfortable walking speed test, functional ambulation categories Measures of participation: Nottingham extended activities of daily living (NEADL) Other secondary outcome measures: Stroke Impact Scale, Falls Efficacy Scale (FES), Hospital Anxiety and Depression Scale (HADS), Fatigue Severity Scale (FSS), Letter cancellation task, the Motricity index (MI‐arm and MI‐leg) Time points when outcomes were assessed: "measured all outcomes before randomisation at baseline and after 12 and 24 weeks" |
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Notes | Full details of this trial, called FIT‐Stroke, have been reported elsewhere (see Van de Port, I, Wevers L, Roelse H, van Kats L, Lindeman E, Kwakkel G. Cost‐effectiveness of a structured progressive task‐oriented circuit class training programme to enhance walking competency after stroke: the protocol of the FIT‐Stroke trial. BMC Neurol 2009;9:43, for more details on trial methodology and randomisation) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were randomly allocated to circuit training or usual physiotherapy, after stratification by rehabilitation centre, with an online randomisation procedure" |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Three trained research assistants (LW, HK, LK), who were blinded to treatment allocation, measured all outcomes before randomisation at baseline and after 12 and 24 weeks in face to face meetings at the patient’s own home or at the rehabilitation centre" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts accounted for "Of the 250 included patients, one patient in the circuit training group and seven in the usual care group were excluded from the analysis. Reasons were withdrawal from participation (n=3), death from cancer (n=2), and recurrent stroke (n=2), while one patient missed the 12 week assessment visit because of change of address. No patients were lost to follow‐up after 12 weeks" |
Free of systematic differences in baseline characteristics of groups compared? | Unclear risk | Significant baseline differences in favour of the circuit training group for a few secondary outcomes |
Did authors adjust for baseline differences in their analyses? | Low risk | Significant baseline differences in favour of the circuit training group for a few secondary outcomes. All analyses, however, were adjusted for these co‐variates at baseline |
Other bias | Unclear risk | "Patients with only mild to moderate stroke were selected, which limits the generalisability of our trial. Able to recruit only a quarter of all patients who were discharged from one of the participating rehabilitation centres. These centres receive about 10% of all patients with stroke discharged from hospitals in the Netherlands. About a third of all patients discharged from these rehabilitation centres showed no or insufficient problems with walking and another third were too ill to be included in the present study" "The combination of workstations in FIT‐Stroke represents an arbitrary selection. Our workstations were selected for safety, clinical relevance in terms of activities, simplicity of execution, and feasibility, without additional costs to the physiotherapy department. Unclear whether a different combination of workstations would have resulted in other outcomes. In our opinion, the workstations for task oriented circuit training should at least be task specific, intensive, and graded in time" |