Santana‐Sosa 2012.
Methods | Design: single‐centre, parallel RCT; 3‐month duration (8 weeks training, 4 weeks detraining). Inclusion criteria: potential participants included 111 children previously diagnosed using a genetic test for CF and treated at the Children’s Hospital Nino Jesus in Madrid. Males or females aged 5 to 15 years and living in the Madrid area (able to attend training sessions). Exclusion criteria: severe lung deterioration, as defined by an FEV1 < 50% predicted; unstable clinical condition (i.e. hospitalisation within the previous 3 months); Burkholderia cepacia infection; musculoskeletal disease or any other disorder impairing exercise. |
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Participants | 22 participants with CF. Group demographics. Training group (n = 11): mean (SEM, range) age 11 years (3 years, 5 ‐ 15 years). Control group (n = 11): mean (SEM, range) age 10.0 years (2 years, 6 ‐ 14 years). |
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Interventions | 8‐week intrahospital programme followed by a 4‐week detraining period. All participants received the same chest physiotherapy during the entire study period. Group 1: endurance and strengthening exercises, 3 times per week. Group 2: control. |
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Outcomes | Included in this study were: VO2 peak; upper and lower body strength (bench press, leg press, seated row); FEV1; FVC; PImax; SaO2 at peak exercise; body weight; BMI; fat‐free mass; body fat; HRQoL; Timed Up and Go test (TUG); Timed Up and Down Stairs test (TUDS). | |
Notes | Additional raw data for all included outcomes provided by the authors | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were randomly assigned to exercise or control group with a block on gender based on the randomisation sequence. No details about how randomisation sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not possible to blind participants to intervention. Personnel involved in training not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded to participants group assignment. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Clear description of missing outcome data. 5 participants could not be assessed at different time points (1 post‐intervention and 4 after detraining) due to hospitalisations (n = 3), relocation (n = 1) and parents who declined further evaluation (n = 1). Dropout rate was unbalanced with 28% in the control group and 9% in the intervention group after the detraining period. Intention‐to‐treat analysis was used and missing outcome data (at post‐training or detraining visit) were replaced by baseline data. |
Selective reporting (reporting bias) | Low risk | All outcomes detailed in methods were reported in results. Data reported for all time points. |
Other bias | High risk | Some raw data were made available, but there were inconsistencies between raw data and data reported in the original publication. There were significant between‐group differences in primary (VO2 peak) and secondary (strength measures) outcome measures at baseline. |