The Effect of a Mobile Application on Enhancing Pulmonary Rehabilitation After Lung Cancer Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Cheng Kung University
About this trial
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:
1. To understand the effectiveness of the pulmonary rehabilitation mobile application in improving lung function. 2. 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
included adjuvant treatments (chemotherapy or radiotherapy)
previous history of thoracic surgery
neurological and/or musculoskeletal comorbidities
visual or hearing impairment
Trial design
Design model
Parallel
Treatments tested in this trial
RehabLung mobile application
BehavioralParticipants in the intervention group will receive in-person pulmonary rehabilitation during their surgical admission and access to a mobile pulmonary rehabilitation application for self-training. This program begins one month before surgery and continues for seven weeks after surgery. The application is designed to encourage participants to engage in pulmonary rehabilitation exercises from preoperative preparation through postoperative care. It offers guided chest breathing exercises, using visual and movement instructions created and remotely prescribed by a physical therapist. Participants will receive daily breathing exercise prescriptions throughout the study period.
Lung cancer postoperative standard care
BehavioralParticipants in the usual care group will receive in-person pulmonary rehabilitation during surgical admission, pre-operative healthcare, and guidance on breathing exercises to practice before surgery. They will also receive post-operative breathing exercise prescriptions to follow at home.
Healthcare interactive Web Platform
Other interventionThe healthcare interactive Web Platform provides patients with surgical information through animations. This includes an introduction to lung surgery, preparation procedures, answers to common patient questions, post-surgery wound care, and a brief guide to pulmonary rehabilitation.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: application inttervention groupExperimental treatment 2 interventions
Group B: Usual care groupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Exercise capacity-oxygen consumption
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.
Time frame
Baseline, post-surgery assessment at week 5, follow-up assessment at week 82
Exercise capacity-workload
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.
Time frame
Baseline, post-surgery assessment at week 5, follow-up assessment at week 83
Exercise capacity-ventilatory efficiency
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).
Time frame
Baseline, post-surgery assessment at week 5, follow-up assessment at week 84
Exercise capacity-Anaerobic threshold
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.
Time frame
Baseline, post-surgery assessment at week 5, follow-up assessment at week 8Secondary outcomes
1
Global respiratory muscle strength
Global respiratory muscle strength is assessed using a pressure gauge and a mouthpiece. Participants are guided to perform maximal exhalation followed by full inhalation, and then maximal inhalation followed by full exhalation through the mouth. Measurements include maximal inspiratory pressure (PImax \[cmH2O, % predicted\]) and maximal expiratory pressure (PEmax \[cmH2O, % predicted\]).
Time frame
Baseline, post-surgery assessment at week 5, follow-up assessment at week 82
Six Minute Walk Test, 6MWT
The six-minute walk test is conducted by having a therapist encourage the participant to walk continuously at a comfortable speed for six minutes. The distance covered during the six-minute walk test (m) will be recorded. Throughout the test, vital signs will be carefully monitored.
Time frame
Baseline, post-surgery assessment at week 5, follow-up assessment at week 83
Postoperative pulmonary complications
Postoperative pulmonary complications (PPCs) will be recorded from medical records including atelectasis, pneumothorax, respiratory infection, respiratory failure, pleural effusion, bronchospasm, aspiration pneumonitis, acute respiratory distress syndrome,
Time frame
Baseline, post-surgery assessment at week 5, follow-up assessment at week 84
Quality of life - EORTC QLQ-C30
Quality of life specific to lung cancer patients is assessed using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30). This questionnaire evaluates various aspects of quality of life, including physical, role, cognitive, emotional, and social functioning, as well as cancer-related symptoms and overall health status. Scores range from 0 to 100 across the 30 items. A higher score on the global scale indicates a better quality of life.
Time frame
Baseline, post-surgery assessment at week 5, follow-up assessment at week 8Other outcomes
1
Demographic data
Body mass index (Kg/m2) Age (years) Sex Smoking (%) (current smokers, never smoked, past smokers) Smoking history (packs/year) Presence of COPD Surgery (lobectomy, minor resection, pneumonectomy) Surgery type (thoracotomy, videothoracoscopy) Histological feature (adenocarcinoma, squamous cell carcinoma, other) Length of hospitalization
Time frame
Baseline, post-surgery assessment at week 5, follow-up assessment at week 82
Adherence
Compliance will be assessed using a self-reported questionnaire that tracks participants\' adherence to the protocol instructions related to breathing exercises, including frequency, technique, duration, and consistency. This self-reported questionnaire includes 28 scaled questions using a 5-point Likert scale, along with one open-ended question to capture any barriers to compliance or reasons for not following the protocol. The compliance score will be calculated based on participants\' responses to the scaled questions and will be expressed as a total compliance score, with higher scores indicating better compliance. The measurement tool will be a customized compliance scale designed for this study, allowing participants to indicate the extent to which they followed the exercise instructions as prescribed.
Time frame
Post-surgery assessment will be conducted at week 5, followed by a follow-up assessment at week 8.3
Compliance
Compliance will be assessed using a self-reported questionnaire that tracks participants\' adherence to the protocol instructions related to breathing exercises, including frequency, technique, duration, and consistency. This self-reported questionnaire includes 28 scaled questions using a 5-point Likert scale, along with one open-ended question to capture any barriers to compliance or reasons for not following the protocol. The compliance score will be calculated based on participants\' responses to the scaled questions and will be expressed as a total compliance score, with higher scores indicating better compliance. The measurement tool will be a customized compliance scale designed for this study, allowing participants to indicate the extent to which they followed the exercise instructions as prescribed
Time frame
Post-surgery assessment will be conducted at week 5, followed by a follow-up assessment at week 8.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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