Lai 2019.
Study characteristics | ||
Methods | Randomised controlled trial Setting: West China Hospital, China Study duration: exercise training: 1 week preoperatively. Assessments performed before and after the preoperative intervention and complications assessed until hospital discharge. |
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Participants | 68 participants (mean age: control group: 63 (SD 8) years; exercise group: 64 (SD 7) years; eligibility age range 45–80 years) with NSCLC, scheduled to undergo lung cancer lobectomy via VATS, with a predicted postoperative FEV1 < 60%. | |
Interventions | Control (34 participants): usual care consisting of routine preoperative preparation, including laboratory and radiological examinations and preoperative education. Exercise (34 participants): 1 week of preoperative physical training combining aerobic and breathing exercises which included: breathing exercises, 20 breaths/session for 3 sessions/day via a volumetric Incentive spirometer (Hudson RCI 2500, Teleflex Inc, USA) under the guidance of specialised nurses. The spirometer was a visual feedback device that encourages maximal inspiration, including breath‐holding; aerobic exercise, 30 minutes/session every day via a Nu‐Step instrument (NuStep Inc, Ann Arbor, MI, USA) under the supervision of physical therapists. |
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Outcomes | Postintervention
Postoperatively
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Notes | Study registered (ChiCTR1800014512). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The patients were randomly assigned into one of two treatment types using a random number table after baseline assessments were completed". |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement of low risk or high risk. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Due to the nature of this research, we could not keep the participants blind to group assignment". Comment: no blinding of participants and personnel. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote from paper: "The study staff and statistical analyses were all blind to patient allocation during data collection". Trial registration: "All study personnel collecting data and conducting statistical analyses were blinded to patient allocation". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "2 IG [exercise group] patients did not complete the training programme, as they could not endure the training intensity (one stopped after the third training day and one at the fourth). Two IG patients and 3 controls were non‐NSCLC, and were all inflammatory nodules except for 1 small cell lung cancer patient in the CG [control] group. However, according to the intention of the treatment principle, all the randomized patients were included in the analysis". Comment: low attrition rate and reasons for attrition stated. |
Selective reporting (reporting bias) | High risk | Comment: trial was prospectively registered (ChiCTR1800014512). The primary outcome reported in the paper and the trial registration did not match. The primary outcome in the paper was not listed in the study registration. The only outcomes on the registry listed were lung‐related complications, quality of life and lung function. The publication also included the outcomes of functional exercise capacity (6MWT), length of hospital stay and inhospital costs. |
Other bias | High risk | Comment: sample size on registry was 200, which varies to the publication including 68 participants. |