de Macedo 2010.
Methods | Design: single‐centre RCT Setting: Brazil Department: paediatric oncology/haematology Randomization: random assignment but no further specifications available Stratification: not mentioned Study duration: 10 weeks Timing: inclusion of the study started during maintenance therapy of the childhood ALL treatment End point measurements: in the intervention group at baseline plus an evaluation every alternate week. In the control group at baseline and 10 weeks thereafter |
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Participants | n = 14 Diagnosis: ALL Age at start of study: mean (± SD) age of the whole group was 8.3 ± 2.6 years (range 5‐14 years). The mean age of the intervention group was 7.0 years and that of the control group 9.0 years Sex: 5 boys and 9 girls Exclusion criteria: children with a chronic lung disease, neuromuscular disease, or those receiving or having received radiotherapy |
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Interventions | This study investigated an inspiratory muscle training programme. They studied the effects of a domiciliary inspiratory muscle training with a duration of 15 minutes, performed twice a day, for 10 weeks. The training was performed with a threshold device using a load of 30% of the maximal inspiratory pressure The control group received care as usual |
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Outcomes |
Physical fitness: Muscle endurance/strength: respiratory muscle strength (maximal inspiratory pressure and maximal expiratory pressure) assessed with a digital manometer Secondary outcomes: None of the secondary outcomes were assessed |
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Notes | Article was written in Portuguese | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Children were randomly selected and randomly assigned to 1 of 2 groups, but the exact randomization methods were not reported |
Allocation concealment (selection bias) | Unclear risk | The exact randomization methods were not reported. It was not clear whether the researchers used sealed envelopes, central allocation, or another method |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The study did not address the blinding of participants and personnel. However, due to the nature of the interventions, blinding was virtually impossible |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The study did not address blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient reporting: the authors stated that sample losses occurred; however, they did not report the reasons for these sample losses, neither did they provide information on the used imputation methods |
Selective reporting (reporting bias) | Low risk | Respiratory muscle strength was the primary outcome. By assessing and reporting on (changes over time of) both the maximal inspiratory pressure and maximal expiratory pressure there was no selective reporting of the study data |
Other bias | High risk | Differential diagnostic activity: the intervention group and the control group received an unequal number of measurements However, this study was free of baseline imbalance; the baseline differences between the control group and intervention group on outcome‐related items were not significant |