Stefanelli 2013.
Study characteristics | ||
Methods | Randomised controlled trial Setting: outpatient clinic. Study undertaken in Naples, Italy Study duration: February 2010 to December 2011 |
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Participants | 40 participants (23 men; mean age 65 (SD 7) years) with chronic obstructive pulmonary disease, undergoing lobectomy (via open thoracotomy) for stage I/II NSCLC were enrolled in study. | |
Interventions | Control (number not reported): usual care with no formal exercise training. Exercise (number not reported): 3‐week (15 × 3‐hour sessions, from Monday to Friday) preoperative outpatient intensive pulmonary rehabilitation programme based on high‐intensity training of both upper‐ and lower‐limb muscles (the upper limbs with the rowing ergometer, and the lower limbs by means of the treadmill and the ergometric bicycle). The exercise work load for each participant was set according to results of cardiopulmonary exercise test, starting with 70% of maximum work rate and increased by 10 watts when the participant was able to tolerate the set load for 30 minutes. The programme also included respiratory exercises on the bench, mattress pad and wall bars. |
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Outcomes | Postintervention and 60 days postoperatively
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Notes | Study did not report on length of hospital stay or postoperative pulmonary complications. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly assigned to two groups". Comment: insufficient information about sequence generation process to permit judgement. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement. |
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 | Unclear risk | Comment: insufficient information to permit judgement. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: insufficient reporting of attrition/exclusions to permit judgement. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Other bias | High risk | Comment: number of participants in each group not reported. |
6MWT: 6‐minute walk test; EORTC QLQ C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; EORTC LC13 CN: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Lung Cancer 13; FEV1: forced expiratory volume in one second; FVC: forced vital capacity; ICU: intensive care unit; IQR: interquartile range; NSCLC: non‐small cell lung cancer; PEF: peak expiratory flow; SD: standard deviation; SF‐36: Medical Outcomes Study 36‐Item Short Form Health Survey; VATS: video‐assisted thoracic surgery; VO2peak: peak oxygen consumption.