Douglas 2015.

Methods	Design: single‐centre RCT (INSPIRE‐CF) in the UK; duration 24 months. Powered to show changes in primary outcome measure of FEV1 z score after 24 months (66 participants needed). Inclusion criteria: not described in abstract. Exclusion criteria: not described in abstract.
Participants	Recruited 71 participants with CF; age 6 to 15.5 years; mean (SD) FEV1 89 (16) % predicted. Group demographics Intervention group (n = 37). Control group (n = 34). 67 children completed the study.
Interventions	Intervention group: standard specialist care including weekly exercise training. Control group: standard specialist care without weekly exercise training.
Outcomes	Included in this study were: average and individual exercise training attendance rates (%); reason for non‐attendance to the exercise training programme. At baseline,12 and 24 months the following outcomes were measured: multiple‐breath washout (lung clearance index); spirometry (FEV1, FVC, FEV1/FVC (measured in litres and converted to z scores)); growth parameters (height; weight; BMI (measured in cm²; kg; and converted to z scores); cardiopulmonary exercise test (Bruce protocol): at peak and anaerobic threshold (VO2 peak; work rate (power); VE/VCO2; RER; HRmax; SaO2; 10m modified shuttle walk test (25‐level version) (distance in meters; level achieved); HRmax; SaO2; Cystic Fibrosis Questionnaire (CFQ UK version). At 6 months only spirometry and the 10 m modified shuttle walk test were repeated.
Notes	INSPIRE‐CF is an 24‐month exercise training study that investigates the effects of an individually tailored and supervised exercise training programme on lung function, exercise capacity and HRQoL for children with CF. This abstract evaluates the participation in the intervention group in the first year of the study (study has been completed, but not yet published in full). Study was powered to show changes after 24 months in primary outcome measure of FEV1 z score; Required 66 participants.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Described as randomised but no details of the method. Randomised by minimisation to one of the two groups (after baseline testing) by an independent blinded medical statistician using the SiMin software package (Wade 2006).
Allocation concealment (selection bias)	Unclear risk	Not discussed.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Not possible to blind participants to intervention. Investigators confirmed that lung function (spirometry and multiple inert gas washout tests), and cycle ergometer cardiopulmonary exercise tests were performed by clinicians who were not made aware of the randomised grouping of the children.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Investigators confirmed blinded outcome assessment.
Incomplete outcome data (attrition bias) All outcomes	Low risk	4 participants dropped out: 1 from the control group at 6 months (social concerns); 3 from the intervention group at 12 months (1 due to moving to a new area and changing hospitals; 2 because they no longer wished to exercise).
Selective reporting (reporting bias)	Unclear risk	This is an abstract so unable to assess if all outcome used in methods were reported in results. Unable to assess if data were reported for all time points.
Other bias	Unclear risk	None identified based on limited information available.