Almajan‐Guta 2011.
| Study characteristics | ||
| Methods | RCT Parallel design Single centre: Romanian National CF centre Duration: 6 months |
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| Participants |
Inclusion criteria: children (age limit not defined). No further inclusion criteria specified Exclusion criteria: not specified 38 participants randomised: (19 = control group) (19 = intervention group) Baseline characteristics Age, range: 7 to 13 years Sex: not specified Disease status of participants: not specified Lung function: not specified |
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| Interventions |
Intervention: PD&P and sport activities 3 times per week Comparator: PD&P |
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| Outcomes | FEV1 % predicted, FVC, FEF25%-75%, number of hospitalisations, participation in school activities, fatigue during daily activities | |
| Identification |
Sponsorship source: supported by CNCSIS (Romanian National Council for Scientific Research in Higher Education) (grant TE36) Country: Romania Authors name: Bogdan Almajan‐Guta Institution: University Politehnica, Sport and Physical Education, Timisoara, Romania; National CF Centre, Timisoara, Romania Email: bogdan.almajan@efs.upt.ro Address: Bulevardul Vasile Pârvan 4, Timișoara 300223, Romania |
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| Notes | Abstract only published. Lead author was contacted on 16 April 2019 and 5 April 2020 for further information and results. No response from authors. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Process of randomisation not described: "This study was conducted for 6 months, in the Romanian National CF centre with 38 patients, randomized in 2 groups." |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not discussed. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not possible due to the type of intervention used. |
| 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 | It is unknown whether or not the outcome assessors were aware of the intervention assignments. It is unclear who the personnel responsible for overseeing the intervention and those responsible for collection of data were. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Abstract only. All outcomes reported in narrative form only, with no access to raw data. No mention of intention‐to‐treat analysis. |
| Selective reporting (reporting bias) | Unclear risk | No protocol for comparison. Only methodology available in abstract. |
| Other bias | Unclear risk | There was a unclear risk of recruitment bias in this study, as it mentioned no exclusion or specific inclusion criteria of participants or baseline characteristics. This may have been due to the limited abstract word count. There was no reported power calculation. There is an unclear risk associated with the potentially insufficient sample size. |