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肺癌切除术后的居家锻炼与自我管理:一项随机临床试验。

Home-Based Exercise and Self-Management After Lung Cancer Resection: A Randomized Clinical Trial.

作者信息

Granger Catherine L, Edbrooke Lara, Antippa Phillip, Wright Gavin, McDonald Christine F, Zannino Diana, Abo Shaza, Krishnasamy Meinir, Irving Louis, Lamb Karen E, Whish-Wilson Georgina, Denehy Linda, Parry Selina M

机构信息

Department of Physiotherapy, The University of Melbourne, Parkville, Victoria, Australia.

Department of Physiotherapy, The Royal Melbourne Hospital, Parkville, Victoria, Australia.

出版信息

JAMA Netw Open. 2024 Dec 2;7(12):e2447325. doi: 10.1001/jamanetworkopen.2024.47325.

Abstract

IMPORTANCE

Patients with lung cancer have poor physical functioning and quality of life. Despite promising outcomes for those who undertake exercise programs, implementation into practice of previously tested hospital-based programs is rare.

OBJECTIVE

To evaluate a home-based exercise and self-management program for patients after lung resection.

DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial with assessor blinding was conducted among 116 patients undergoing surgery for non-small cell lung cancer from November 23, 2017, to July 31, 2023, at tertiary hospitals in Australia. Patients were followed up for 12 months postoperatively.

INTERVENTION

Patients randomized to the intervention group received a postoperative 3-month home-based exercise and self-management program, supported by weekly physiotherapist-led telephone consultations. Patients randomized to the control group received usual care.

MAIN OUTCOMES AND MEASURES

The primary outcome was self-reported physical function (30-item European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC QLQ-C30] score) at 3 months. Secondary outcomes included objective measures of physical function and exercise capacity (at 3 and 6 months) and patient-reported outcomes including quality of life (at 3 and 6 months, with some questionnaires completed at 12 months). Analysis was performed on an intent-to-treat basis.

RESULTS

A total of 1370 patients were screened, with 177 eligible and 116 consented (mean [SD] age, 66.4 [9.6] years; 68 women [58.6%]). Of these 116 patients, 58 were randomized to the intervention and 58 to the control. A total of 103 patients (88.8%) completed assessments at 3 months, 95 (81.9%) at 6 months, and 95 (81.9%) at 12 months. There were no statistically significant differences between the intervention and control groups for self-reported physical function (EORTC QLQ-C30 physical functioning domain score) at the 3-month primary end point (mean [SD] score, 77.3 [20.9] vs 76.3 [18.8]; mean difference, 1.0 point [95% CI, -6.0 to 8.0 points]). Patients in the intervention group, compared with the control group, had significantly greater exercise capacity (6-minute walk distance: mean difference, 39.7 m [95% CI, 6.8-72.6 m]), global quality of life (mean difference, 7.1 points [95% CI, 0.4-13.8 points]), and exercise self-efficacy (mean difference, 16.0 points [95% CI, 7.0-24.9 points]) at 3 months as well as greater objectively measured physical function (Short Physical Performance Battery score: mean difference, 0.8 points [95% CI, 0.1-1.6 points]), exercise capacity (6-minute walk distance: mean difference, 50.9 m [95% CI, 6.7-95.1 m]), and exercise self-efficacy (mean difference, 10.1 points [95% CI, 1.9-18.2 points]) at 6 months. One minor adverse event and no serious adverse events occurred.

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, a postoperative home-based exercise and self-management program did not improve self-reported physical function in patients with lung cancer. However, it did improve other important clinical outcomes. Implementation of this program into lung cancer care should be considered.

TRIAL REGISTRATION

http://anzctr.org.au Identifier: ACTRN12617001283369.

摘要

重要性

肺癌患者身体功能和生活质量较差。尽管参加运动计划的患者有良好的预后,但此前经过测试的医院运动计划在实际应用中却很少见。

目的

评估肺癌切除术后患者的居家运动和自我管理计划。

设计、地点和参与者:2017年11月23日至2023年7月31日在澳大利亚三级医院对116例接受非小细胞肺癌手术的患者进行了一项评估者设盲的随机临床试验。对患者术后进行了12个月的随访。

干预措施

随机分配到干预组的患者接受为期3个月的术后居家运动和自我管理计划,并由物理治疗师每周进行一次电话咨询提供支持。随机分配到对照组的患者接受常规护理。

主要结局和测量指标

主要结局是3个月时自我报告的身体功能(30项欧洲癌症研究与治疗组织核心生活质量问卷 [EORTC QLQ-C30] 评分)。次要结局包括身体功能和运动能力的客观测量指标(3个月和6个月时)以及患者报告的结局,包括生活质量(3个月和6个月时,部分问卷在12个月时完成)。分析采用意向性分析。

结果

共筛查了1370例患者,其中177例符合条件,116例同意参与(平均 [标准差] 年龄为66.4 [9.6] 岁;68名女性 [58.6%])。在这116例患者中,58例被随机分配到干预组,58例被随机分配到对照组。共有103例患者(88.8%)在3个月时完成评估,95例(81.9%)在6个月时完成评估,95例(81.9%)在12个月时完成评估。在3个月的主要终点,干预组和对照组在自我报告的身体功能(EORTC QLQ-C30身体功能领域评分)方面无统计学显著差异(平均 [标准差] 评分,77.3 [20.9] 对76.3 [18.8];平均差异为1.0分 [95% 置信区间,-6.0至8.0分])。与对照组相比,干预组患者在3个月时运动能力显著更强(6分钟步行距离:平均差异为39.7米 [95% 置信区间,6.8 - 72.6米])、整体生活质量更高(平均差异为7.1分 [95% 置信区间,0.4 - 13.8分])以及运动自我效能感更强(平均差异为16.0分 [95% 置信区间,7.0 - 24.9分]),在6个月时客观测量的身体功能(简短身体表现量表评分:平均差异为0.8分 [95% 置信区间,0.1 - 1.6分])、运动能力(6分钟步行距离:平均差异为50.9米 [95% 置信区间,6.7 - 95.1米])和运动自我效能感(平均差异为10.1分 [95% 置信区间,1.9 - 18.2分])也更强。发生了1例轻微不良事件,无严重不良事件。

结论和相关性

在这项随机临床试验中,术后居家运动和自我管理计划并未改善肺癌患者自我报告的身体功能。然而,它确实改善了其他重要的临床结局。应考虑将该计划应用于肺癌护理。

试验注册

http://anzctr.org.au 标识符:ACTRN12617001283369

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8fd/11612835/259b69583710/jamanetwopen-e2447325-g001.jpg

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