The Effectiveness of a Mobile Lung Rehabilitation System on Patient Satisfaction and Lung Function After Lung Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Exercise capacity-oxygen consumption
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of a mobile application intervention on postoperative lung rehabilitation. The main purposes of this study are:
- To understand the effectiveness of the pulmonary rehabilitation mobile application in improving lung function.
- To assess the feasibility of the pulmonary rehabilitation mobile application in post-surgery rehabilitation care.
Researchers will compare the intervention group (using the pulmonary rehabilitation mobile application) to the usual care group to determine if the mobile application is effective in lung surgery rehabilitation.
Participants will join the study immediately after providing informed consent and will continue for up to 7 weeks post-surgery. Participants will be randomly allocated to either the intervention group or the control group. Both groups will receive regular pulmonary rehabilitation during their hospital stay (1 day before surgery and 2 to 3 days after surgery). Researchers will guide participants in the intervention group to use the mobile application for pulmonary rehabilitation exercises throughout the study period. Participants in the usual care group will receive health education and an exercise guide before discharge. Participants will undergo three study assessments: at baseline (within 1 week after enrollment), post-surgery (week 5), and at follow-up (week 8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 20 years
- •primary diagnosis of lung cancer at any stage and type
- •referral to lung cancer resection by thoracotomy or videothoracoscopy
- •ability to understand and consent to the trial procedures
- •conscious and cognition intact
排除标准
- •included adjuvant treatments (chemotherapy or radiotherapy)
- •previous history of thoracic surgery
- •neurological and/or musculoskeletal comorbidities
- •visual or hearing impairment
- •acute respiratory illness
结局指标
主要结局
Exercise capacity-oxygen consumption
时间窗: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8
Cardiorespiratory fitness is evaluated by a cardiopulmonary exercise test using a cycle ergometer. Participants will be encouraged to perform a cycle ergometer stress test to assess their cardiopulmonary function. During the test, the workload will gradually increase by 10 watts per minute until the participant reaches peak exercise capacity. Throughout the exercise test, participants will be carefully monitored for echocardiography and heart rate, and will wear a mask to analyze ventilatory outcomes using a computed gas analysis system. Peak oxygen consumption (VO2 peak) will be measured during the exercise test, and values for the difference and change in percent predicted (peak oxygen uptake \[mL/kg/min\], VO2 peak difference \[mL/kg/min\], VO2 peak change \[%\], and \[% predicted\]) will be obtained from gas analysis. The predicted values will be referenced from the system based on race, age, height, biological sex, and weight.
Exercise capacity-workload
时间窗: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8
Cardiorespiratory fitness is evaluated by a cardiopulmonary exercise test using a cycle ergometer. Participants will be encouraged to perform a cycle ergometer stress test to assess their cardiopulmonary function. During the test, the workload will gradually increase by 10 watts per minute until the participant reaches peak exercise capacity. Throughout the exercise test, participants will be carefully monitored for echocardiography and heart rate, and will wear a mask to analyze ventilatory outcomes using a computed gas analysis system. The workload achieved during exercise test will be recored by peak work rate (watts), and peak work rate (%pred.) The predicted workload will be referenced from the system based on race, age, height, biological sex, and weight.
Exercise capacity-ventilatory efficiency
时间窗: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8
Cardiorespiratory fitness is evaluated by a cardiopulmonary exercise test using a cycle ergometer. Participants will be encouraged to perform a cycle ergometer stress test to assess their cardiopulmonary function. During the test, the workload will gradually increase by 10 watts per minute until the participant reaches peak exercise capacity. Throughout the exercise test, participants will be carefully monitored for echocardiography and heart rate, and will wear a mask to analyze ventilatory outcomes using a computed gas analysis system. The gas analysis of oxygen exchange efficiency includes maximal ventilation (L/min), maximal ventilation (% predicted), ventilatory equivalents slope, VE/VCO2 slope, ventilatory equivalents, and VE/VCO2 (% predicted).
Exercise capacity-Anaerobic threshold
时间窗: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8
Cardiorespiratory fitness is evaluated by a cardiopulmonary exercise test using a cycle ergometer. Participants will be encouraged to perform a cycle ergometer stress test to assess their cardiopulmonary function. During the test, the workload will gradually increase by 10 watts per minute until the participant reaches peak exercise capacity. Throughout the exercise test, participants will be carefully monitored for echocardiography and heart rate, and will wear a mask to analyze ventilatory outcomes using a computed gas analysis system. Anaerobic threshold (AT) (mL/kg/min) is defined as a nonlinear increase in CO2 production, which will be analyze during gas analysis in an incremental exercise test.
Pulmoanry function
时间窗: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8
The pulmonary function test, assessed by spirometry, is performed to evaluate lung volumes over time and ventilatory capacity. Participants will be guided by experienced therapists to take a maximal inspiration, then exhale with maximal effort for as long and as fast as possible. Measurements include forced vital capacity (FVC \[L, % predicted\]), forced expiratory volume in one second (FEV1 \[L, % predicted\]), and the ratio of the two volumes (FEV1/FVC \[% predicted\]). The predicted values will be referenced from large population studies of healthy adults, matched by race, age, height, biological sex, and weight.
次要结局
- Global respiratory muscle strength(Baseline, post-surgery assessment at week 5, follow-up assessment at week 8)
- Six Minute Walk Test, 6MWT(Baseline, post-surgery assessment at week 5, follow-up assessment at week 8)
- Postoperative pulmonary complications(Baseline, post-surgery assessment at week 5, follow-up assessment at week 8)
- Quality of life - EORTC QLQ-C30(Baseline, post-surgery assessment at week 5, follow-up assessment at week 8)
- Qulaity of life-WHOQOL-BREF(Baseline, post-surgery assessment at week 5, follow-up assessment at week 8)
研究者
Kun-Ling Tsai
Professor
National Cheng Kung University