Cerny 1989.
| Study characteristics | ||
| Methods | RCT Parallel design Single centre: Buffalo, New York Duration: 2 weeks |
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| Participants |
Inclusion criteria: acute exacerbation of pulmonary disease, defined as, "increased shortness of breath, coughing and sputum production and decreased lung function"; able to perform pulmonary function tests Exclusion criteria: not specified Pretreatment: no attempt was made to match participants for disease severity 17 participants: (8 = control) (9 = intervention group) Baseline characteristics PD&P Group Age, mean (SD): 15.9 (4.9) years Height, mean (SD): 151.6 (14.2) cm Weight, mean (SD): 38.4 (14.4) kg Pulmonary function score, mean (SD): 14.9 (0.9) Exercise therapy + PD&P Group Age, mean (SD): 15.4 (4.9) years Height, mean (SD): 149.5 (14.6) cm Weight, mean (SD): 35.9 (10.5) kg Pulmonary function score, mean (SD): 12.2 (1.3) |
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| Interventions |
Intervention: cycle ergometer: on days 1 to 4, a workload of 25% to 45% of peak HRR; on day 4 to discharge, a workload of 40% to 65% of peak HRR, target duration 15 to 20 mins 2x daily AND PD&P 20 to 40 mins 1 x daily, no inhaled bronchodilator pre‐treatment Comparator: PD&P in 6 positions, 20 to 40 mins 3 x daily with inhaled bronchodilator pretreatment |
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| Outcomes | FEV1 % predicted (change from baseline), FVC % predicted (change from baseline), duration of hospitalisation, FEF25-75, FRC % predicted, peak load (w/kg), peak heart rate, peak VE, sputum dry weight (g), sputum volume, sputum wet weight (g), adherence, adverse events, pulmonary function score at discharge | |
| Identification |
Sponsorship source: supported in part by NIH Grants 5R01AM24066 and RR‐05493C and by the Buffalo Foundation Country: USA Setting: inpatient, hospital Authors name: Frank J Cerny Institution: Department of Paediatrics, Division of Pulmonary Disease, Children's Hospital, Buffalo Email: Frank.cerny@verizon.net Address: Department of physical therapy and exercise science, State University of New York at Buffalo, 411 Kimball Tower, Buffalo, New York 14214 (USA) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No method of randomisation stated: "The patients were randomly assigned to either a group that participated in two cycle ergometer sessions per day and one bronchial hygiene treatment session per day or a group that participated in three bronchial hygiene treatment sessions per day." |
| Allocation concealment (selection bias) | Unclear risk | No concealment of allocation discussed. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants not possible. |
| Blinding of participants and personnel (performance bias ‐ subjective outcomes) Subjective outcomes | High risk | Blinding was not possible due to the type of intervention used. Participant awareness of the intervention may have led to some impact on reporting of subjective measures, such as QoL, due to pre‐existing perceptions or preferences on the benefits of exercise versus traditional airway clearance techniques. |
| Blinding of participants and personnel (performance bias ‐ objective outcomes) Objective outcomes | Unclear risk | Blinding was not possible due to the type of intervention used; however this was unlikely to confer any impact on objective outcome measures such as lung function and exercise testing. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated who the outcome assessors were and whether or not they were blinded to allocation. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All randomised participants completed the trial with similar numbers of participants in each group: intervention (9), comparator (8). No re‐inclusions in analyses performed by the review authors. "All postural drainage treatments were completed as required for the study and 96% of scheduled exercise sessions were completed." There is no mention of how authors dealt with this missing data. Intention to treat analysis not discussed. |
| Selective reporting (reporting bias) | Unclear risk | All outcomes described in the methods section were reported in numerical or graphical format or commented on in the discussion, except wet sputum weight. New outcomes were not added. Outcomes of interest were not changed throughout the study. There were no numerical data provided for daily sputum volume or dry sputum weight. |
| Other bias | High risk | Intervention length varied ‐ exercise was set to a "target duration of 15 to 20 minutes" whereas "PD with chest percussion and vibration in six positions for 20 to 40 minutes." The comparison intervention was also preceded by bronchodilator therapy. The effect of this on the outcomes is unknown. No baseline characteristics tables included in full publication. The effect of potentially unmatched groups of participants was deemed high risk. There was no reported power calculation. There is an unclear risk associated with the potentially insufficient sample size. |
ACBT: active cycle of breathing techniques CF: cystic fibrosis FEF25-75: mid forced expiratory flow FEV1: forced expiratory volume in 1 second FRC: functional residual capacity FVC: forced vital capacity HRR: heart rate reserve PD&P: exercise plus postural drainage and percussion PEP: positive expiratory pressure RCT: randomised controlled trial SPO2: oxygen saturation SD: standard deviation VAS: visual analogue scale VE: minute ventilation VO2 max: maximum rate of oxygen consumption measured during incremental exercise