A randomized trial of aerobic exercise in colorectal cancer: Rationale, design, recruitment, and exercise adherence results

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-10-01 DOI:10.1016/j.cct.2024.107702

Stephanie L.E. Compton , Shengping Yang , Lauren S. Maniscalco , Reem A. Muhsen , Pratibha Shrestha , Xiaocheng Wu , Kaylee T. Woodard , Elizabeth R.M. Zunica , Eunhan Cho , Rachel L. Wall , John Brown , Anjana Jayaraman , Brian J. Kirby , L. Anne Gilmore , Frank L. Greenway , Guillaume Spielmann , Justin C. Brown

{"title":"A randomized trial of aerobic exercise in colorectal cancer: Rationale, design, recruitment, and exercise adherence results","authors":"Stephanie L.E. Compton , Shengping Yang , Lauren S. Maniscalco , Reem A. Muhsen , Pratibha Shrestha , Xiaocheng Wu , Kaylee T. Woodard , Elizabeth R.M. Zunica , Eunhan Cho , Rachel L. Wall , John Brown , Anjana Jayaraman , Brian J. Kirby , L. Anne Gilmore , Frank L. Greenway , Guillaume Spielmann , Justin C. Brown","doi":"10.1016/j.cct.2024.107702","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>The primary objective of the EXACT trial is to determine if randomization to 150 min 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 were identified using χ<sup>2</sup> or Fisher's exact test for categorical variables and <em>t</em>-tests or analysis of covariance (ANCOVA). Exercise adherence was calculated as the total minutes exercised by total minutes prescribed.</div></div><div><h3>Results</h3><div>Between August 2019 and February 2023, 3082 colorectal cancer survivors were invited to participate, 89 were screened, and 60 were randomized to the study protocol. Younger age (<em>P</em> = 0.02), female sex (<em>P</em> = 0.002), white race (<em>P</em> = 0.01), proximal time since tumor resection (<em>P</em> = 0.02), and regional tumor stage (<em>P</em> < 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.</div></div><div><h3>Conclusion</h3><div>The results from the EXACT trial will characterize the changes that occur from exercise to advance our understanding of the biological mechanisms by which exercise may prevent tumor recurrence and death in colorectal cancer survivors.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107702"},"PeriodicalIF":2.0000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424002854","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

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 min 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 were identified 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, 3082 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 will characterize the changes that occur from exercise to advance our understanding of the biological mechanisms by which exercise may prevent tumor recurrence and death in colorectal cancer survivors.

查看原文本刊更多论文

大肠癌有氧运动随机试验：原理、设计、招募和坚持锻炼的结果。

背景：体育锻炼与结直肠癌幸存者无病生存率的提高有关。本报告介绍了美国国立癌症研究所（NCI）发起的运动与结直肠癌治疗（EXACT）试验的目的、设计、招募和运动坚持情况：EXACT试验的主要目的是确定与候补对照组相比，随机安排每周150分钟的中等强度有氧运动是否能在12周内减少I-III期结直肠癌幸存者的全身炎症。研究人员为参与者提供了家用跑步机和心率监测器。对分类变量采用χ2或费雪精确检验，对随机化相关特征采用t检验或协方差分析（ANCOVA）。运动依从性以运动总分钟数乘以处方总分钟数计算：2019年8月至2023年2月期间，3082名结直肠癌幸存者受邀参加，89人接受了筛查，60人被随机分配到研究方案中。年龄较小（P = 0.02）、性别为女性（P = 0.002）、种族为白人（P = 0.01）、肿瘤切除术后近端时间（P = 0.02）和区域肿瘤分期（P 结论：EXACT试验的结果将在2019年8月至2023年2月期间公布：EXACT 试验的结果将描述运动所产生的变化，从而加深我们对运动可预防结直肠癌幸存者肿瘤复发和死亡的生物机制的了解。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.