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

Morano 2013.

Study characteristics
Methods Randomised controlled trial
Setting: teaching hospital in Ceara, Brazil
Study duration: March 2008 to March 2011. Exercise training: 4 weeks preoperatively. Assessments performed before and after preoperative intervention. Postoperative outcomes obtained from medical records.
Participants 24 participants (mean age: control group: 69 (SD 7) years; exercise group: 65 (SD 8) years) with NSCLC, who were undergoing lung resection via open thoracotomy or VATS, and had impaired lung function.
31 participants recruited, 7 excluded, 5 of whom refused participation, and 2 did not meet inclusion criteria because of normal pulmonary function.
Interventions Control (12 participants): usual care consisting of instructions about lung expansion techniques
Exercise (12 participants): 5 sessions/week for 4 weeks of upper and lower limb endurance training (prescribed at 80% of maximum work rate achieved during a treadmill incremental test); inspiratory muscle training; and flexibility, stretching and balance exercises.
Both groups had education: classes about the importance of preoperative and postoperative care and knowledge of the surgical process, energy conservation techniques, relaxation and stress management techniques, focus on nutrition, and the need to seek health services when necessary.
Outcomes Postintervention
  1. Physical capacity using: unsupported upper limb exercise test, endurance testing and 6MWT

  2. Quality of life using SF‐36

  3. Anxiety and depression using Hospital Anxiety and Depression Scale

  4. Serum fibrinogen and albumin using a blood sample collected in disposable Vacutainer tubes

  5. Lung function using spirometry


Postoperatively
  1. Length of hospital stay

  2. Postoperative pulmonary complications: pneumonia (new infiltrate plus either fever (temperature > 38 °C), and white blood cell count > 11,000 mm3, or fever and purulent secretions), bronchopleural fistula, bronchospasm, severe atelectasis (confirmed by chest radiographs, requiring chest physiotherapy or bronchoscopy), prolonged need for chest tubes (> 7 days), and prolonged mechanical ventilation (> 48 hours).

Notes Study published in 2 different papers. Paper published in 2013 focused on postoperative outcomes, whereas paper published in 2014 focused on postintervention (preoperative) outcomes.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "patients were randomly assigned to undergo a preoperative PR [pulmonary rehabilitation] or CPT [chest physical therapy] programme. The randomisation was done in blocks of 4".
Comment: insufficient information about the sequence generation process to permit judgement.
Allocation concealment (selection bias) Unclear risk Quote: "The randomisation was done in blocks of 4, and individual allocations were placed in sealed envelopes. An external investigator blinded to the allocation sequence picked the envelopes".
Comment: insufficient information to permit judgement.
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Single‐blinded".
Comment: no blinding of participants and personnel.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote: "Postoperative outcomes were obtained from the medical records by a physical therapist blinded to the treatment assignment".
Comment: although postoperative outcomes were obtained by a physical therapist blinded to the treatment assignment, it is unclear whether postintervention outcome measures were taken by a blind assessor. Therefore, there was insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: 2013 study: "Three patients in the CPT [chest physical therapy] arm were not submitted to lung resection because of inoperable cancer".
Quote: 2014 study: "All 24 participants successfully completed the training assignments".
Comment: 2013 study: all participants accounted for. Greater dropouts in control group but reasons given.
Selective reporting (reporting bias) High risk Comment: some reported outcomes were not prespecified in the study protocol (UTN number: U1111‐1122‐2906) and not all the study's prespecified outcomes were reported.
Other bias Low risk Comment: study appeared free of other sources of bias.