Licker 2016.
Study characteristics | ||
Methods | Randomised controlled trial Setting: University Hospital of Geneva and the Hospital of Valais, Switzerland Study duration: October 2011 to October 2014. Exercise: time before surgery (median 26 days, IQR 21–33 in the exercise group). Assessments performed before and after intervention, after surgery and 12 months postoperative |
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Participants | 151 participants (mean age: control group: 64 (SD 10) years; exercise group: 64 (SD 13) years) scheduled for lung resection with suspected or confirmed NSCLC stage IIIA or less; via VATS or open approach 164 participants recruited, 13 excluded (control group: 3 withdrew and 3 had operation cancelled; exercise group: 3 withdrew and 2 had operation cancelled |
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Interventions | Control (77 participants): usual care consisting of preoperative advice regarding active mobilisation (≥ 4 × 30‐minute walks per week) and risk factor management (e.g. healthy nutrition and smoking and alcohol cessation). Exercise (74 participants): usual care plus preoperative rehabilitation based on high‐intensity interval training delivered in an outpatient clinic. Exercise on a cycling ergometer 2 or 3 times a week under supervision physiotherapists. High‐intensity interval training: 5‐minute warm‐up period at 50% at peak work rate; then 2 × 10‐minute series of 15‐second sprint intervals (at 80–100% peak work rate) interspersed by 15‐second pauses and a 4‐minute rest between the 2 series; then 5‐minute active recovery period at 30% peak work rate cool down. Additional exercises, such as leg press, leg extension, back extension, seat row, biceps curls, or chest and shoulder press, were proposed on an individual basis. Outpatient programme run in an outpatient clinic. |
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Outcomes | Postintervention
Postoperatively
12 months postoperatively
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Notes | Study published as 3 different papers. First paper published in 2017 (Licker et al) focused on early postoperative outcomes, second paper published in 2017 (Karenovics et al) focused on 12‐month postoperative outcomes and third paper published in 2019 (Bhatia et al) focused on proof‐of‐concept of the specific exercise protocol. Study registered (NCT01258478). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Consenting patients were randomized on a 1:1 basis into a rehabilitation (Rehab) arm and UC arm by using a permuted block of four patients". Comment: insufficient information to permit judgement of low risk or high risk. |
Allocation concealment (selection bias) | Unclear risk | Quote: "The randomization sequence was developed before initiation of the trial and concealed until after enrolment". Comment: insufficient information to permit judgement of low risk or high risk. |
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: "Study was a prospective randomized, open, blinded end point controlled trial using assessor blinding". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 77/81 participants in control group and 74/83 in exercise group. 8 participants withdrew and 5 participants had operations cancelled. Missing outcome data balanced in numbers across groups, with similar reasons for missing data across groups. |
Selective reporting (reporting bias) | High risk | Comment: trial registry (NCT01258478) included secondary outcomes that were not reported in publications: quality of life scores, electrocardiogram, nutritional status and smoking behaviour (changes baseline to 3 weeks). |
Other bias | Low risk | Comment: study appeared free of other sources of bias. |