Skip to main content
. 2017 Nov 1;2017(11):CD002768. doi: 10.1002/14651858.CD002768.pub4

Santana‐Sosa 2014.

Methods Design: single‐centre, parallel RCT; 3‐month study (8 weeks training, 4 weeks detraining).
Inclusion criteria: potential participants included 95 outpatient children previously diagnosed with CF by genetic testing and treated at the Children’s Hospital Nino Jesus in Madrid. Males or females aged 6 – 17 years and living in the Madrid area (able to attend training sessions).
Exclusion criteria: severe lung deterioration (FEV1 < 50% predicted); unstable clinical condition (i.e., hospitalisation within the previous 3 months); Burkholderia cepacia infection or any disorder (e.g., musculoskeletal) impairing exercise.
Participants 20 participants with CF.
Group demographics
Training group (n = 10): mean (SEM) age 11.1 (1.1) years.
Control group (n = 10): mean (SEM) age 10.1 (1.1) years.
Interventions 8‐week programme followed by a 4‐week detraining period. All participants received the same standard chest physiotherapy.
Group 1: whole body aerobic and weight training 3 times per week, plus two daily inspiratory muscle training sessions
Group 2: control group performed inspiratory muscle training only at a low intensity.
Outcomes Included in this study were: VO2 peak; FVC; FEV1; PImax; SaO2 at peak exercise, muscle strength; body weight; body fat; fat‐free mass; and HRQoL.
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 Randomisation to intervention or control group with block on gender. No details given for sequence generation.
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. 3 participants of the control group could not be assessed at different time points (1 for post‐intervention and detraining phase and 2 after detraining phase) due to hospitalisation for lung transplantation preparation (n = 1), infection with Burkholderia cepacia (n = 1) and refusal (n = 1).
Unbalanced distribution of dropouts. Dropout rate in the control group was 30% versus none in the intervention group.
Intention‐to‐treat analysis was reported, but it is not clear how missing data were handled.
Selective reporting (reporting bias) Low risk All outcome 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. Significant between‐group differences in primary outcomes (VO2 peak and strength measures) existed at baseline.