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') |
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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 |
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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. |
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Outcomes |
Primary outcomes
Secondary outcomes
Other outcomes
Outcomes were measured at baseline, after 8 weeks of training and after 4 weeks of detraining. |
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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. |
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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. |