A Randomized Trial of Aerobic Exercise in Colorectal Cancer: Rationale, Design, Recruitment, and Exercise Adherence Results
Abstract
Background Physical activity is associated with improved disease-free survival in colorectal cancer survivors. This report describes the purpose, design, recruitment, and exercise adherence results of the National Cancer Institute (NCI)-sponsored Exercise and Colorectal Cancer Treatment (EXACT) trial. Methods The primary objective of the EXACT trial is to determine if randomization to 150 minutes per week of moderate-intensity aerobic exercise reduces systemic inflammation among stage I-III colorectal cancer survivors compared with a waitlist control group over 12 weeks. Participants were provided with an in-home treadmill and heart rate monitor. Characteristics associated with randomization using χ2 or Fisher’s exact test for categorical variables and t-tests or analysis of covariance (ANCOVA). Exercise adherence was calculated as the total minutes exercised by total minutes prescribed. Results Between August 2019 and February 2023, 3,082 colorectal cancer survivors were invited to participate, 89 were screened, and 60 were randomized to the study protocol. Younger age (P=0.02), female sex (P=0.002), white race (P=0.01), proximal time since tumor resection (P=0.02), and regional tumor stage (P<0.001) were associated with study participation. Average exercise adherence was 92.2% (95% CI: 85.5, 98.8) and all study participants achieved ≥80% exercise adherence. Endpoint data collection was completed for all participants in May 2023. Conclusion The results from the EXACT trial…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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