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

Santana‐Sosa 2014.

Study characteristics
Methods Design: single‐centre, parallel RCT
Location: Children's Hospital Infantil Universitario Niño Jesús in Madrid, Spain
Inclusion criteria: potential participants included 95 outpatient children previously diagnosed with CF by genetic testing and treated at the Children's Hospital Niño Jesús in Madrid. Males or females aged 6 to 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
Duration: 3‐month study (8 weeks' training, 4 weeks' 'detraining')
Participants 20 participants with CF
Group demographics
Intervention group (n = 10): mean age 11.1 (SEM 1.1) years
Control group (n = 10): mean age 10.1 (SEM 1.1) years
Interventions 8‐week programme followed by a 4‐week detraining period. All participants received the same standard chest physiotherapy
Intervention group: whole body aerobic and weight training 3 times per week, plus 2 daily inspiratory muscle training sessions
Control group: inspiratory muscle training only at a low intensity.
Outcomes Primary outcomes
  1. Change in lung function (FEV1; FVC; PImax)

  2. Change in VO2 peak measured by treadmill CPET


Secondary outcomes
  1. Change in dynamic muscle strength (upper and lower body strength (bench press, leg press, seated row))

  2. Change in body composition (BW; fat‐free mass; body fat)

  3. Change in HRQoL (CFQ‐R)


Other outcomes
  1. Adherence to exercise training

  2. Adverse effects of exercise training


Outcomes were measured at baseline, after 8 weeks of training and after 4 weeks of detraining.
Notes Additional raw data for all included outcomes provided by the authors.
Study authors used the term 'detraining', which is a time period during which no supervised exercise training was provided. The meaning of 'detraining' is consistent with our term 'off training', which also describes a period during which no (partially) supervised physical activity took place, but study participants were not explicitly discouraged from undertaking physical activity.
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 High 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 from control group could not be assessed at different time points (1 at postintervention 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 control group was 30% versus 0% in intervention group.
Intention‐to‐treat analysis was reported, but it was not clear how missing data were handled.
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. Significant between‐group differences in primary outcomes (VO2 peak and strength measures) existed at baseline.