Effect of Home-based Preoperative Exercise Training on Quality of Life After Lung Cancer Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Changes in health-related quality of life
研究概览
简要总结
Lung cancer accounts for over 11% of global cancer incidence and is the leading cause of cancer death, with numbers in 2020 reaching 1.8 million deaths worldwide.
For early-stage lung cancer patients, surgical resection is the recommended treatment and the intervention associated with a better prognosis. However, in consequence of surgery there is a substantial deterioration in health-related quality of life across most dimensions, especially in the first month, with 100% of lung cancer patients concerned about the limitations in their physical function and 96% about the levels of fatigue and pain after lobectomy.
Additionally, some patients developed postoperative pulmonary complications, which are associated with increased length of hospital stay and higher risk of mortality.
In this context, and considering that the number of lung cancer cases with an indication for surgery will increase by 60% from 2018 to 2040, to find feasible and effective interventions that could optimize postoperative recovery is of major clinical relevance.
The primary purpose of this study will be to evaluate the efficacy of home-based preoperative exercise training to improve health-related quality of life after lung cancer surgery. The secondary purpose of this study will be to evaluate the efficacy of the home-based exercise program to improve physical performance and to reduce postoperative complications /length of hospital stay. Participants will be randomly allocated to a preoperative exercise intervention, that will consist of combined aerobic and resistance exercise, or to a control group that will receive usual care (i.e., no exercise training).
Based on the strong evidence indicating a therapeutic effect of exercise training on fatigue and physical function, domains of HRQOL especially affected after lung cancer surgery, the investigators hypothesized that the home-based exercise program will be effective to improve these domains before surgery and attenuate its deterioration after surgery, optimizing the recovery in postoperative HRQOL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for surgical treatment of suspected or confirmed lung cancer (clinical stage IIIA or less)
- •Waiting time for surgery of at least two weeks from baseline assessment
- •Medical clearance to exercise.
- •Signed informed consent prior to initiation of study-related procedures
排除标准
- •Metastatic cancer
- •Presence of physical or mental disabilities that contraindicated exercise training or physical testing
- •Unable to communicate in Portuguese or English
- •Performing combined aerobic plus resistance training over the past month (self-reported ≥2 days a week, ≥30 minutes each session).
结局指标
主要结局
Changes in health-related quality of life
时间窗: Baseline to 3-5 weeks after surgery
Will be assessed through the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) (version 3.0). The QLQ-C30 is composed of 30 questions, including five multi-item functioning scales, three multi-item symptom scales, six single-item symptom scales, and a two-item global health status scale \[GHS\]. Scores range from 0 to 100 points, with a higher score on the functioning scales indicating a higher level of functioning, whereas a higher score on the symptom scales indicates a higher level of symptom burden. In addition, the investigators will assess EORTC QLQ-C30 summary score (SumSc) because it provides a psychometrically more robust alternative to the GHS score that is frequently used as the primary HRQOL endpoint in clinical trials. The SumSc is calculated from the mean of 13 of the 15 QLQ-C30 scores (the GHS and financial impact scales are excluded).
次要结局
- Changes in exercise capacity(Baseline to 3-5 weeks after surgery)
- Changes in five times sit to stand test(Baseline to 3-5 weeks after surgery)
- Postoperative complications(30 days after surgery)
- Changes in handgrip strength(Baseline to 3-5 weeks after surgery)
- Postoperative length of hospital stay(3-6 days after surgery)
- Exercise attendance rate(Baseline to 2-3 days before surgery)
- Exercise compliance rate(Baseline to 2-3 days before surgery)
- Adverse events(Baseline to 2-3 days before surgery)
研究者
Pedro Machado
Principal Investigator
Instituto Politécnico de Leiria