Effects of Community-based Exercise Prehabilitation for Patients Scheduled for Colorectal Surgery With High Risk for Postoperative Complications: Results of a Randomized Clinical Trial.

"JMK received research funding from Amgen. Amgen had no role in the study design, acquisition, analysis, and/or interpretation of the data, nor in writing the report and submission. Other authors report no conflicts of interest."

"This study was performed with funding from Amgen."

"This prospective, single-blinded, randomized clinical trial was carried out at 2 large Dutch teaching hospitals (Medisch Spectrum Twente in Enschede and Ziekenhuisgroep Twente in Almelo). Trial methodology and experimental intervention were designed to conform state-of-the-art recommendations (using the Cochrane risk of bias tool and CONTENT scale, respectively), as well as by using a clinical decision rule to select the right (high-risk) patients for prehabilitation; this way, methodological risk of bias is minimized and therapeutic validity is ensured. The trial started in February 2014 and inclusion was completed in December 2018. Patients with colorectal cancer or premalignant colorectal lesions (polyps with grade I-III dysplasia that could not be removed endoscopically) scheduled for elective colorectal resection were recruited. Eligible patients were ≥60 years, had a life expectancy >6 months as estimated by the surgeon, had a metabolic equivalent of task (MET) score ≤7 on the veterans-specific activity questionnaire (VSAQ), were willing to perform community-based prehabilitation at a physical therapy practice in the catchment area of both hospitals, and were able to perform a progressive cardiopulmonary exercise test (CPET). The VSAQ was used to preselect those patients with a potentially low preoperative aerobic fitness. We obtained written informed consent from all patients who met the inclusion criteria and were willing to participate. For definite inclusion, patients also had to have a low preoperative aerobic fitness (high risk for postoperative complications) at the baseline CPET, defined as a VO2 at the VAT <11 mL/kg/min. Patients in the prehabilitation group and in the usual care group were all treated within an enhanced recovery pathway according to the enhanced recovery after surgery protocol. The study was approved by the local medical ethics committee Twente in Enschede and by the institutional review boards of Ziekenhuisgroep Twente, the Netherlands (registration number P13–18), and was registered in the Netherlands Trial Registry (NTR4032). The trial followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline and was conducted according with the ethical standards of the Helsinki Declaration of 1975. A complete overview of the study protocol has been published."