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. 2022 Aug 9;2022(8):CD002768. doi: 10.1002/14651858.CD002768.pub5

Hatziagorou 2019.

Study characteristics
Methods Design: single‐centre, partially supervised, parallel‐group RCT
Location: Aristotle University of Thessaloniki, Greece
Inclusion criteria: not stated
Exclusion criteria: not stated
Duration: 12 months
Participants 30 participants with CF (50% male)
Mean age 16.2 years; mean FEV1 91.2 (SD 20.1) % predicted; mean VO2 peak 80.9 (SD 17.6) % predicted
Group demographics
Intervention group (n = 15): mean FEV1 90.1% predicted; mean VO2 peak 72.7% predicted
Control group (n = 15): mean FEV1 92.2% predicted; VO2 peak 89.1% predicted
Interventions Intervention group: individualised exercise training programme; supervised using accelerometry
Control group: no exercise training
Outcomes
  1. FEV1 (% predicted)

  2. VO2 peak (% predicted)

Notes Limited information as published as abstract only. The abstract stated that participants were divided into 2 groups. We contacted the authors to clarify the study design. The first author of the abstract and principal investigator (Elpis Hatziagorou) confirmed that the study was an RCT. The Principal Investigator confirmed that the trial is a partially supervised intervention, in which a physiotherapist provides instructions and feedback regarding exercise training at outpatient follow‐up visits. Assessments were performed at 1, 3, 6 and 12 months after baseline assessments.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not discussed.
Allocation concealment (selection bias) Unclear risk Not discussed.
Blinding of participants and personnel (performance bias)
All outcomes High risk Not possible to blind participants to intervention. Unclear whether personnel were blinded.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not discussed.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No details of dropouts or whether it used an intention‐to‐treat analysis.
Selective reporting (reporting bias) Unclear risk Abstract, so unable to assess if all outcomes used in methods were reported in results.
Other bias Unclear risk Did not state inclusion or exclusion criteria, neither did they describe the methods of statistical analysis used.