Britto 2011.
| Methods | Double‐blind RCT Random list was generated using random blocks but with no details. After correspondence with the authors, it was clarified that patients were randomly allocated using a computer random number generator Allocation sequence was done using sequentially numbered, sealed opaque envelopes to make sure the participants and investigators could not predict allocation Double blinded: all study physicians, participants and outcome assessors were blinded ITT analysis: no, dropouts were not included in the final analysis |
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| Participants | Setting: Brazil 21 patients who had a stroke within 9 months were randomly assigned into either the inspiratory muscle training group (11 patients) or the sham inspiratory muscle training group (10 patients) for 8 weeks 9 patients in the inspiratory muscle training group finished the study: 4 females and 5 males, age 56.66 ± 5.56 years* 9 patients in the sham training group finished the study: 5 females and 4 males, age 51.44 ± 15.98 years* Exclusion criteria: restriction in pulmonary function and neurological, orthopaedic or unstable cardiac disease |
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| Interventions | Intervention group: inspiratory muscle training for 8 weeks Control group: sham inspiratory muscle training for 8 weeks without resistance valve of the threshold trainer |
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| Outcomes |
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| Notes | 2 patients in the inspiratory muscle training group were lost to follow‐up due to lack of time to complete the training, and 1 patient in the sham training group was lost to follow‐up due to hypertension: all 3 patients were excluded from the analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer random number generator ‐ information available from the author |
| Allocation concealment (selection bias) | Low risk | Using sequential sealed opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Triple blinding of physicians, participants and outcome assessors |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Triple blinding of physicians, participants and outcome assessors |
| Incomplete outcome data (attrition bias) All outcomes | High risk | The number of dropouts was carefully reported and balanced between groups 2 patients in the inspiratory muscle training group and 1 patient in the sham training group were lost to follow‐up, but all 3 patients were excluded from analyses |
| Selective reporting (reporting bias) | Low risk | Not identified |
| Other bias | Low risk | Not identified |