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

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.
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.
Outcomes Postintervention
  1. Exercise capacity using 6MWT

  2. Health‐related quality of life using the EORTC QLQ C30

  3. Lung function as FVC, FEV1, maximum voluntary ventilation, diffusing capacity of the lungs for carbon monoxide, postoperative predicted FEV1 and postoperative predicted diffusing capacity of the lungs for carbon monoxide

  4. Fatigue and dyspnoea using the BORG on the 6MWT

  5. Arterial blood gases (blood oxygen saturation, partial pressures of oxygen and carbon dioxide)


Postoperatively
  1. Length of hospital stay

  2. Postoperative pulmonary complications based on The Society of Thoracic Surgeons and the European Society of Thoracic Surgeons General Thoracic Surgery (STS/ESTS) complication definition and Clavien–Dindo complication classification

  3. Inhospital costs

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.