Novel Methods for Reporting of Exercise Dose and Adherence: An Exploratory Analysis

ABSTRACTPurposeTo explore whether methods adapted from oncology pharmacological trials have utility in reporting adherence (tolerability) of exercise treatment in cancer.MethodsUsing a retrospective analysis of a randomized trial, 25 prostate cancer patients received an aerobic training regimen of 72 supervised treadmill walking sessions delivered thrice-weekly between 55% to 100% of exercise capacity for 24 consecutive weeks. Treatment adherence (tolerability) was assessed using conventional (lost to follow up (LTF) and attendance) and exploratory [e.g., permanent discontinuation, dose modification, relative dose intensity (RDI)] outcomes.ResultsThe mean total cumulative "planned" and "completed" dose was 200.7 ± 47.6 MET.hrs and 153.8 ± 68.8 MET.hrs, respectively, equating to a mean RDI of 77% ± 24%. Two patients (8%) were LTF and mean attendance was 79%. A total of 6 (24%) of 25 patients permanently discontinued aerobic training prior to week 24. Aerobic training was interrupted (missing ≥3 consecutive sessions) or dose reduced in a total 11 (44%) and 24 (96%) patients, respectively; a total 185 of 1800 (10%) training sessions required dose reduction owing to both health-related (all non-serious) and non health-related adverse events (AEs). 18 (72%) patients required at least one session to be terminated early; a total of 59 (3%) sessions required early termination.ConclusionNovel methods for the conduct and reporting of exercise treatment adherence and tolerability may provide important information beyond conventional metrics in patients with cancer. Purpose To explore whether methods adapted from oncology pharmacological trials have utility in reporting adherence (tolerability) of exercise treatment in cancer. Methods Using a retrospective analysis of a randomized trial, 25 prostate cancer patients received an aerobic training regimen of 72 supervised treadmill walking sessions delivered thrice-weekly between 55% to 100% of exercise capacity for 24 consecutive weeks. Treatment adherence (tolerability) was assessed using conventional (lost to follow up (LTF) and attendance) and exploratory [e.g., permanent discontinuation, dose modification, relative dose intensity (RDI)] outcomes. Results The mean total cumulative "planned" and "completed" dose was 200.7 ± 47.6 MET.hrs and 153.8 ± 68.8 MET.hrs, respectively, equating to a mean RDI of 77% ± 24%. Two patients (8%) were LTF and mean attendance was 79%. A total of 6 (24%) of 25 patients permanently discontinued aerobic training prior to week 24. Aerobic training was interrupted (missing ≥3 consecutive sessions) or dose reduced in a total 11 (44%) and 24 (96%) patients, respectively; a total 185 of 1800 (10%) training sessions required dose reduction owing to both health-related (all non-serious) and non health-related adverse events (AEs). 18 (72%) patients required at least one session to be terminated early; a total of 59 (3%) sessions required early termination. Conclusion Novel methods for the conduct and reporting of exercise treatment adherence and tolerability may provide important information beyond conventional metrics in patients with cancer. Correspondence: Lee W. Jones, PhD, Department of Medicine, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, email: jonesl3@mskcc.org This study was supported by a research grant from the National Cancer Institute (R21-CA133895) awarded to LWJ. TSN, LWJ, JS, CC, and MM are supported by the Kalvi Trust, AKTIV Against Cancer and the Memorial Sloan Kettering Cancer Center Support Grant/Core Grant (P30 CA008748). The authors would like to thank Whitney Underwood for administrative support. Authors declare no conflict of interests. The results of the present study do not constitute endorsement by ACSM. The results of the study are presented clearly, honestly, and without fabrication, falsification, or inappropriate data manipulation. Accepted for Publication: 15 December 2017 © 2018 American College of Sports Medicine

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