Selvadurai 2002.
| Study characteristics | ||
| Methods | Randomised controlled study. Inpatient study with follow up in the outpatient period. | |
| Participants | 66 children with CF admitted to the Royal Alexandra Hospital for Children for treatment of a pulmonary exacerbation. Aged 8 ‐ 16 years. Aerobic training group: n = 22 (9 male); mean (SD) age 13.2 years (2.0); body mass 37.9 kg (7.4); FEV1 56.8 % predicted (17.9); VO2 33.8 ml/kg/min (17.0); Strength 155 Nm (19); QOL 0.62 (0.28). Resistance training group: n = 22 (10 male); mean (SD) age 13.1 years (2.1); body mass 38.1 kg (8.2); FEV1 58.0 % predicted (16.8); VO2 34.2 ml/kg/min (17.8); strength 156 Nm (21); QOL 0.60 (0.26). Control group: n = 22 (9 male); mean age (SD): 13.2 years (2.0); body mass: 38.5 kg (8.0); FEV1: 57.4 %predicted (17.3); VO2: 34.0 ml/kg/min (17.7); strength: 155 Nm (20); QOL: 0.62 (0.29). |
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| Interventions | Participants randomised to one of 3 groups: Aerobic training group (n = 22); Resistance training group (n = 22); Control group (n = 22).
Aerobic training group: participants completed supervised aerobic activities for 5 sessions, each of 30‐minutes duration, for a week. Activities included treadmill running or stationary cycling at 70% of peak HR. If required, supplemental oxygen to maintain oxygen saturation of at least 90% administered. If dyspnoea scored reached 7 (modified 0 ‐ 10 point Borg score) session ceased prior to 30‐minutes. Resistance training group: participants undertook upper and lower limb resistance exercises using a non‐isokinetic resistance machine with built‐in graded incremental resistance dial. Load of 70% of maximal subjective resistance established at commencement of each session. 5 sets of 10 repetitions of each exercise completed. Supervised sessions 5 times per week were undertaken. Control Group: participants undertook standard chest physiotherapy but did not attend exercise training sessions. |
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| Outcomes | Outcomes assessed at admission (within 36 hours) and discharge from hospital, and 1‐month post discharge from hospital. Weight: kg Height: cm Fat free mass: kg ‐ using skin fold thickness from four sites. Pulmonary function: FEV1 % predicted; FVC % predicted Exercise capacity: VO2 ‐ ml/kg/min; VCO2; V'E; RQ Lower limb strength (Nm): non‐dominant hamstring and quadriceps femoris strength measured using an isokinetic Cybex dynamometer. QOL: Quality of Well Being Scale* (administered on admission and 1‐month post discharge only). Physical activity participation: MJ/day ‐ activity diary and accelerometer count over 1‐week at 1‐month post discharge only. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated. |
| Allocation concealment (selection bias) | Low risk | Opaque envelopes used to conceal participant allocation order. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel aware of group allocation, the nature of the intervention would make this type of blinding difficult. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated. Awareness of group allocation by outcome assessors could have impacted upon exercise capacity testing, QOL measures and lung function testing. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 66 children randomised ‐ 2 participants missed some aspect of training sessions. The paper states "none of the children were withdrawn from the study" however the number of participants assessed at hospital discharge and one‐month post discharge is not specifically stated. It is assumed they continued on to assessment based on the statement of no withdrawals. |
| Selective reporting (reporting bias) | Unclear risk | Physical activity data completed by a subset of participants whom had previously undertaken equivalent assessment. All other outcome measures reported. |
| Other bias | Unclear risk | Subset of participants who completed physical activity assessment had previously had their baseline levels of physical activity established as a part of another study. The inclusion criteria for this alternate study were not stated. |
CF: cystic fibrosis CXR: chest X‐ray FEF25-75: forced expiratory flow from 25% to 75% of vital capacity FEV1: forced expiratory volume at one second FVC: forced vital capacity HR: heart rate kg: kilograms Max HR: maximum heart rate (beats per minute) MaxVE: maximum ventilation MJ: mega‐joules MVV: maximum voluntary ventilation Nm: Newton metres PEFR; peak expiratory flow rate QOL: quality of life RQ: respiratory quotients RV: residual volume SD: standard deviation TLC: total lung capacity VCO2:carbon dioxide production V'E: minute ventilation VO2: oxygen update (expressed in millilitres per kilogram of body weight per minute) VO2max: maximum oxygen update Wmax:maximum work capacity