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

Liu 2020.

Study characteristics
Methods Randomised controlled trial
Setting: Peking Union Medical College Hospital, China
Study duration: between March 2017 to December 2017. Exercise for 2 weeks preoperative. Assessments performed before and after the intervention, and 30 days postoperative.
Participants 73 participants (mean age: control group: 56 (SD 9) years; exercise group: 56 (SD 10) years; eligibility was aged < 70 years) with newly suspected or confirmed NSCLC, clinical stage I–III, who were scheduled for lobectomy via VATS.
85 participants recruited, 12 were excluded because of not receiving lobectomy surgery (6), failure of follow‐up (5) or final pathology was not NSCLC (1).
Interventions Control (36 participants): usual care consisting of a comprehensive preoperative anaesthesia assessment, perioperative drug recommendations for chronic diseases, smoking cessation and abstinence. No specific recommendations for preoperative exercise, diet or mental health.
Exercise (37 participants): 2‐week preoperative multimodal intervention programme. Exercises performed in the home. Programme included:
  1. 30 minutes of moderate‐ to high‐intensity aerobic endurance exercise (jogging, walking, cycling, at discretion) ≥ 3 days per week

  2. resistance exercise involving major muscle groups (upper and lower limbs, chest and core muscles) performed twice a week. Stretching and strengthening exercises using an elastic resistance band (resistance levels according to baseline strength) were the main form of anaerobic exercise and were taught by a doctor of physical therapy at baseline

  3. respiratory training included 3 sessions: a. a Tri‐Ball Respiratory Exerciser (Leventon SA, Barcelona, Spain) for breathing exercises; b. cough training; c. blowing up a small balloon in 1 breath and holding for > 5 seconds. Respiratory training for 10 minutes at least twice daily

  4. nutrition counselling with whey protein supplementation (Inerish; Sino‐American Medical Institute Inc, San Diego, CA, USA) daily to achieve adequate protein intake, recommended as 1.5 g/kg/day

  5. psychological guidance (basic mental relaxation with music)

Outcomes Postintervention and 30 days postoperatively
  1. Exercise capacity using 6MWT

  2. Lung function (FEV1, FVC, PEF, FEV1/FVC ratio)

  3. Disability using 12‐item World Health Organization Disability Assessment Schedule II

  4. Mood using Hospital Anxiety and Depression Scale


Postoperatively
  1. Length of hospital stay

  2. Postoperative complications (Clavien–Dindo classification)

  3. Short‐term recovery quality (consecutively measured in the first 3 days after surgery using the 9‐item quality of recovery QoR‐9 score)

  4. Chest tube duration

  5. Mortality

Notes Study registered (NCT03068507).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were then assigned randomly to the prehabilitation or control group according to computer‐generated random numbers".
Allocation concealment (selection bias) Low risk Quote: "assigned randomly to the prehabilitation or control group according to computer‐generated random numbers concealed in sealed envelopes."
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: "A doctor blinded to group allocation assessed all patients".
Incomplete outcome data (attrition bias)
All outcomes Low risk Quotes: "85 were enrolled and randomized. Twelve patients were excluded because of not receiving lobectomy surgery (n = 6), failure of follow‐up (n = 5), or the final pathology was not NSCLC (n = 1). The number of patients excluded in the analyses was balanced, and the reasons for dropping out were comparable between groups".
"There were no significant differences between the analyzed population and the patients who were randomized but excluded in terms of demographic and physiological characteristics".
Comment: missing outcome data balanced in numbers across groups, with similar reasons for missing data across groups. Attrition rate low (14%).
Selective reporting (reporting bias) High risk Comment: trial registered (NCT03068507). The registry states quality of life was measured but this was not reported in the publication. The publication included data on extra outcomes not specified in the trial registry. The publication included data on lung function, short‐term recovery quality, length of hospital stay, chest tube duration, postoperative complications and mortality, which were not recorded on the registry.
Other bias High risk Quote: "A sample size of 70 (35 per group) was required to detect a statistically significant difference at a 2‐sided significance level of.05 and 90% statistical power. To account for patient dropouts and missing data, we planned to recruit a total of 85 patients".
Comment: sample size on trial registry (100 participants) differed to the publication (70 participants).