Rodriguez Hortal 2016.
Methods | RCT. Parallel design. Duration: both interventions given 2x daily for 60 min for 3 months. |
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Participants | 32 participants with CF. Mean (SD) age: 31 (10) years. Moderate to severe lung disease. Baseline FEV₁ % predicted mean (SD) (range): 47% (14) (22% to 69%). Baseline FVC % predicted mean (SD): 69% (13).%. |
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Interventions |
Intervention 1: treatment including bronchodilators; AD with HTS for 15 min; then NIV with face mask; FET/huffing from mid to low lung volume.
Intervention 2: treatment including bronchodilators; AD with HTS for 15 min; then PEP with mask; FET/huffing from mid to low lung volume. NIV: IPAP 20 cm H₂O minimum; EPAP 10 cm H₂O. PEP: 10 breaths with 10 to 20 cm H₂O resistance. |
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Outcomes | Lung function (FEV₁; FVC; LCI), 6MWT, PaCO₂, sputum culture, inflammatory blood markers. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States randomised but no further details given. |
Allocation concealment (selection bias) | Low risk | States opaque envelopes were used to assign to 1 of 2 groups. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Pulmonary lab technicians blinded to physiotherapy treatment took lung function readings; research nurses blinded to treatment took vital signs; 6MWT was performed by the physiotherapist although it is unclear if the physiotherapist conducting the 6MWT is blinded to treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were accounted for. |
Selective reporting (reporting bias) | Low risk | It is stated that inflammatory blood markers, blood gases and sputum analysis monthly was non‐significant compared to baseline (data not reported); FRC did not change in either group (data not reported). All other outcome measures were reported. |
Other bias | Low risk | Methods of statistical analysis were reported. |