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. 2022 Sep 28;2022(9):CD012020. doi: 10.1002/14651858.CD012020.pub3

Lai 2017b.

Study characteristics
Methods Randomised controlled trial
Setting: West China Hospital, China
Study duration: 1 January 2015 to 30 December 2015. Exercise training performed 1 week preoperatively. Assessments before and after preoperative intervention and complications assessed to 30 days postoperative.
Participants 101 participants (mean age: control group: 65 (SD 7) years; exercise group: 64 (SD 8) years) with NSCLC and presence of selected risk factors for postoperative pulmonary complications (> 20 pack‐year smoking history, aged > 75 years, body mass index > 30, postoperative predicted percentage FEV1 < 60%, postoperative predicted diffusing capacity of the lungs for carbon monoxide < 60% or chronic obstructive pulmonary disease) who were scheduled to undergo lung resection via VATS or open approach.
Interventions Control (50 participants): usual care consisted of routine care, including preoperative inhospital education, preoperative preparation (relevant examinations and arrangements) and essential encouragement or psychological caring.
Exercise (51 participants): 1‐week high‐intensity pulmonary rehabilitation preoperative programme run as inpatients. This included 1. thoracic expansion and incentive spirometry exercises (performed with visual feedback device – HUDSON RCI 2500, Teleflex, Temecula, CA, USA), 20 breaths per session for 3 sessions per day; 2. abdominal breathing exercises twice daily for 15–30 minutes per session while seated or recumbent with knees bent and shoulders relaxed; 3. aerobic endurance exercises performed daily for 30 minutes per session using a Nu‐Step device (NuStep Inc, Ann Arbor, MI, USA).
Outcomes Postintervention
  1. Functional exercise capacity using 6MWT

  2. Health‐related quality of life using EORTC QLQ C30 and LC13_CN version 3)

  3. PEF

  4. Fatigue using BORG score on 6MWT

  5. Dyspnoea using BORG score on 6MWT

  6. Energy consumption during 6MWT and blood gas analysis


Postoperatively
  1. Length of hospital stay

  2. Postoperative pulmonary complications (occurring within 30 days identified and recorded as 1. atelectasis, 2. acute respiratory distress syndrome, 3. respiratory failure, 4. mechanical ventilation at 48 hours postoperatively, 5. deep vein thrombosis/pulmonary embolism and 6. empyema or pneumonia, which was defined as ≥ 3 of: leukocytosis > 11,200/mm3 or < 3000/mm3, temperature > 38.5 °C, purulent sputum, persistent infiltrate on chest radiograph or pathogenic micro‐organisms cultured from endotracheal aspirate)

  3. Inhospital expenses included a daily nursing care fee, intraoperative examination cost, surgery‐related expenses and drug costs

Notes Study registered as a parallel group trial (ChiCTRIOR‐16008109).
Under this trial registry number, study was published as 3 different papers. 1 paper published in 2017 (Lai et al 2017b) included 2 groups (control and exercise) and included 101 participants; another paper published in 2017 (Huang et al) included 3 groups (control, exercise with inspiratory muscle training and inspiratory muscle training alone) and 90 participants; another paper was published in 2016 (Lai et al) in Chinese with 48 participants.
For this purpose of this Cochrane Review, we used the Lai et al 2017b paper for data retrieval and analysis.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were allocated to a treatment or a control group, based on a randomization table generated by a computer by an independent person".
Allocation concealment (selection bias) Low risk Quote: "group allocation placed in sequential opaque envelopes. Group allocation was revealed by a research assistant".
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "It is impossible for the patients to be blinded to their treatment group allocation due to the nature of the exercise intervention".
Comment: no blinding of participants and personnel.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "all study personnel collecting data and conducting statistical analyses were blinded to patient allocation".
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "6 patients did not finish the 7‐day regimen. Two of them required an operation before completing the 7‐day regimen; 2 requested withdrawal from the study because of a perceived lack of benefit; and 2 requested withdrawal because they felt they could not endure the regimen".
Comment: 6 participants did not complete the intervention; however, both Figure 1 and Table 2 of the paper suggest that all participants were included in the final analysis.
Selective reporting (reporting bias) High risk Quote: "Our study showed improvements in PEF and 6‐min walk distance and reductions in the total/postoperative length of stay, in‐hospital costs and occurrence of PPCs [postoperative pulmonary complications]".
Comment: study registered retrospectively (ChiCTRIOR‐16008109; www.chictr.org.cn/showprojen.aspx?proj=13593).
Study included results on hospital length of stay and inhospital expenses, which were not registered as outcomes on the registry.
Other bias High risk Comment: the registry reported a sample size of 144 (not 101 as reported in this publication).
The registry included different inclusion and exclusion criteria to the study.