Hwang 2012.
Methods | Design: Randomised controlled trial Setting: outpatient clinic, Taiwan Study duration: 8 weeks | |
Participants | 44 participants with stage NSCLC being treated with epidermal growth factor receptor inhibitors were invited. 24 randomised, 18 completed. 111 participants participated. Exercise group: n = 13 (5 M), mean age 61 (6.3) years, BMI 22.6 (2.4), 77% stage IV, 0 were current or ex smokers, 2.6 (2.1) months following diagnosis. Control group: n = 11 (7 M), mean age 58.5 (8.2) years, 91% stage IV, 1 was current or ex‐smokers, 2.8 (2.4) months post diagnosis. |
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Interventions |
Exercise (n=13): eight weeks of aerobic exercise 30‐40min, 2‐5 min intervals; intervals 80% VO2peak or RPE 15‐17, 60% VO2peak RPE 11‐13; 10 min warm up, 5 min cool down, performed 3 times per week. Control (n=11): usual care, general patient education, and social phone calls every 2–3 weeks, without supervised exercise intervention. General exercise instructions with the Theraband® Elastic Band were given if the subjects in the control group specifically asked for exercise consultation. |
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Outcomes | Exercise capacity (VO2peak), muscle force‐generating capacity (peak torque; right quad; isokinetic Biodex Nm), HRQoL (EORTC Global), dyspnoea (EORTC dyspnoea), fatigue (EORTC Fatigue) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "A computer number generator was used to assign a random order..." Quote: "A minor reallocation was made at the beginning of the study..." Comment: three participants were reallocated based on patient preference. |
Allocation concealment (selection bias) | Unclear risk | Quote: "This allocation procedure was performed by an individual who was unaware of the purpose of this study." Comment: insufficient information to permit judgment of 'low risk' or 'high risk' |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no blinding of participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All tests were performed by a blinded assessor". Comment: blinding of outcome assessment ensured, and unlikely that the blinding could have been broken |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: there was higher dropout from the intervention group compared to the control group. Comment: potentially inappropriate application of simple imputation (baseline observation carried forward) |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol available. Insufficient information to permit judgment of 'low risk' or 'high risk' |
Other bias | Low risk | Comment: the study appears to be free of other sources of bias. |