Simon Nørskov Thomsen, Rikke Krabek, Christina Yfanti, Stine Sjöberg, Anna Sundberg, Ditte Munch Dalsgaard, Laura Mølgaard Thomsen, Eske Kvanner Aasvang, Camilla Qvortrup, Morten Mau-Sørensen, Bente Klarlund Pedersen, Peter Nørgaard Larsen, Martin Hylleholt Sillesen, Nicolai Aagaard Schultz, Jesper Frank Christensen, Casper Simonsen
{"title":"结直肠肝转移患者术后运动训练随机对照试验","authors":"Simon Nørskov Thomsen, Rikke Krabek, Christina Yfanti, Stine Sjöberg, Anna Sundberg, Ditte Munch Dalsgaard, Laura Mølgaard Thomsen, Eske Kvanner Aasvang, Camilla Qvortrup, Morten Mau-Sørensen, Bente Klarlund Pedersen, Peter Nørgaard Larsen, Martin Hylleholt Sillesen, Nicolai Aagaard Schultz, Jesper Frank Christensen, Casper Simonsen","doi":"10.1097/SLA.0000000000006587","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Postoperative morbidity can reduce quality of life, physical performance, and tolerability of postoperative chemotherapy in patients with colorectal liver metastases (CRLM). Exercise can improve these outcomes in some cancer populations. However, it remains unknown whether exercise can be delivered in the early postoperative period following surgery for CRLM without increasing the risk of harms.</p><p><strong>Objective: </strong>The primary objective was to compare the number of serious adverse events (SAEs) with exercise intervention versus control. The secondary objectives were to compare non-SAEs, chemotherapy dose modifications, patient-reported outcomes, cardiorespiratory fitness, and physical performance.</p><p><strong>Methods: </strong>Patients with CRLM scheduled to open surgery with or without postoperative chemotherapy were randomized 2:1 to intervention or control. The intervention group performed 30-50 min low-to-high intensity exercise 5 times/week for 8 weeks, initiated one day after postoperative hospital discharge. The primary outcome was SAEs. The secondary outcomes were SAEs; chemotherapy dose modifications; patient-reported outcomes; cardiorespiratory fitness; and physical performance.</p><p><strong>Results: </strong>Fifty-five participants were randomized. The number of SAEs was similar between the groups (between-group difference [95% CI]: -0.07 [-0.59; 0.43] events), whereas the number of non-SAEs was lower in intervention (between-group difference [95% CI]: -4.65 [-9.14; -0.17] events). We found between-group differences in time to postoperative chemotherapy (intervention: 25 days, control; 42 days) and chemotherapy dose modifications (RR [95%CI]: 0.55 [0.35; 0.88]). Additionally, we found between-group differences in quality of life, cardiorespiratory fitness, and physical performance, in favor of intervention.</p><p><strong>Conclusions: </strong>Early-onset postoperative exercise exhibit a favorable harms-benefit profile in patients with CRLM. This warrants further investigation in larger randomized controlled trials.</p><p><strong>Trial registration: </strong>Prospectively registered at clinicaltrials.gov (NCT04751773).</p>","PeriodicalId":8017,"journal":{"name":"Annals of surgery","volume":" ","pages":""},"PeriodicalIF":7.5000,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Postoperative Exercise Training in Patients with Colorectal Liver Metastases A Randomized Controlled Trial.\",\"authors\":\"Simon Nørskov Thomsen, Rikke Krabek, Christina Yfanti, Stine Sjöberg, Anna Sundberg, Ditte Munch Dalsgaard, Laura Mølgaard Thomsen, Eske Kvanner Aasvang, Camilla Qvortrup, Morten Mau-Sørensen, Bente Klarlund Pedersen, Peter Nørgaard Larsen, Martin Hylleholt Sillesen, Nicolai Aagaard Schultz, Jesper Frank Christensen, Casper Simonsen\",\"doi\":\"10.1097/SLA.0000000000006587\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Postoperative morbidity can reduce quality of life, physical performance, and tolerability of postoperative chemotherapy in patients with colorectal liver metastases (CRLM). Exercise can improve these outcomes in some cancer populations. However, it remains unknown whether exercise can be delivered in the early postoperative period following surgery for CRLM without increasing the risk of harms.</p><p><strong>Objective: </strong>The primary objective was to compare the number of serious adverse events (SAEs) with exercise intervention versus control. The secondary objectives were to compare non-SAEs, chemotherapy dose modifications, patient-reported outcomes, cardiorespiratory fitness, and physical performance.</p><p><strong>Methods: </strong>Patients with CRLM scheduled to open surgery with or without postoperative chemotherapy were randomized 2:1 to intervention or control. The intervention group performed 30-50 min low-to-high intensity exercise 5 times/week for 8 weeks, initiated one day after postoperative hospital discharge. The primary outcome was SAEs. The secondary outcomes were SAEs; chemotherapy dose modifications; patient-reported outcomes; cardiorespiratory fitness; and physical performance.</p><p><strong>Results: </strong>Fifty-five participants were randomized. The number of SAEs was similar between the groups (between-group difference [95% CI]: -0.07 [-0.59; 0.43] events), whereas the number of non-SAEs was lower in intervention (between-group difference [95% CI]: -4.65 [-9.14; -0.17] events). We found between-group differences in time to postoperative chemotherapy (intervention: 25 days, control; 42 days) and chemotherapy dose modifications (RR [95%CI]: 0.55 [0.35; 0.88]). Additionally, we found between-group differences in quality of life, cardiorespiratory fitness, and physical performance, in favor of intervention.</p><p><strong>Conclusions: </strong>Early-onset postoperative exercise exhibit a favorable harms-benefit profile in patients with CRLM. This warrants further investigation in larger randomized controlled trials.</p><p><strong>Trial registration: </strong>Prospectively registered at clinicaltrials.gov (NCT04751773).</p>\",\"PeriodicalId\":8017,\"journal\":{\"name\":\"Annals of surgery\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":7.5000,\"publicationDate\":\"2024-11-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of surgery\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/SLA.0000000000006587\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/SLA.0000000000006587","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
Postoperative Exercise Training in Patients with Colorectal Liver Metastases A Randomized Controlled Trial.
Background: Postoperative morbidity can reduce quality of life, physical performance, and tolerability of postoperative chemotherapy in patients with colorectal liver metastases (CRLM). Exercise can improve these outcomes in some cancer populations. However, it remains unknown whether exercise can be delivered in the early postoperative period following surgery for CRLM without increasing the risk of harms.
Objective: The primary objective was to compare the number of serious adverse events (SAEs) with exercise intervention versus control. The secondary objectives were to compare non-SAEs, chemotherapy dose modifications, patient-reported outcomes, cardiorespiratory fitness, and physical performance.
Methods: Patients with CRLM scheduled to open surgery with or without postoperative chemotherapy were randomized 2:1 to intervention or control. The intervention group performed 30-50 min low-to-high intensity exercise 5 times/week for 8 weeks, initiated one day after postoperative hospital discharge. The primary outcome was SAEs. The secondary outcomes were SAEs; chemotherapy dose modifications; patient-reported outcomes; cardiorespiratory fitness; and physical performance.
Results: Fifty-five participants were randomized. The number of SAEs was similar between the groups (between-group difference [95% CI]: -0.07 [-0.59; 0.43] events), whereas the number of non-SAEs was lower in intervention (between-group difference [95% CI]: -4.65 [-9.14; -0.17] events). We found between-group differences in time to postoperative chemotherapy (intervention: 25 days, control; 42 days) and chemotherapy dose modifications (RR [95%CI]: 0.55 [0.35; 0.88]). Additionally, we found between-group differences in quality of life, cardiorespiratory fitness, and physical performance, in favor of intervention.
Conclusions: Early-onset postoperative exercise exhibit a favorable harms-benefit profile in patients with CRLM. This warrants further investigation in larger randomized controlled trials.
Trial registration: Prospectively registered at clinicaltrials.gov (NCT04751773).
期刊介绍:
The Annals of Surgery is a renowned surgery journal, recognized globally for its extensive scholarly references. It serves as a valuable resource for the international medical community by disseminating knowledge regarding important developments in surgical science and practice. Surgeons regularly turn to the Annals of Surgery to stay updated on innovative practices and techniques. The journal also offers special editorial features such as "Advances in Surgical Technique," offering timely coverage of ongoing clinical issues. Additionally, the journal publishes monthly review articles that address the latest concerns in surgical practice.