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Pulmonary RehabilitationNCT06600503

The Effect of a Mobile Application on Enhancing Pulmonary Rehabilitation After Lung Cancer Surgery

A study testing RehabLung mobile application and Healthcare interactive Web Platform in people with Pulmonary Rehabilitation and Telerehabilitation, run by National Cheng Kung University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
RehabLung mobile application and Healthcare interactive Web Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
1 Oct 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • included adjuvant treatments (chemotherapy or radiotherapy)
  • previous history of thoracic surgery
  • neurological and/or musculoskeletal comorbidities
  • visual or hearing impairment
  • acute respiratory illness

Trial locations and contacts

No sites are listed yet.

About this study

Official title: The Effectiveness of a Mobile Lung Rehabilitation System on Patient Satisfaction and Lung Function After Lung Cancer Surgery

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.
Read more

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).

Being tested
RehabLung mobile application, Lung cancer postoperative standard care, Healthcare interactive Web Platform
Keywords
pulmonary rehabilitation, mobile application, Telerehabilitation, Lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RehabLung mobile applicationBehavioural

    Also called The application group, RehabLung App

    Participants 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 careBehavioural

    Also called usual care, Standard chest rehabilitation

    Participants 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 PlatformOther

    The 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.

Study groups in NCT06600503
Study groupRoleWhat they receive
application inttervention groupExperimentalThe experimental group will receive standard postoperative care, including chest rehabilitation, a mobile application for remote self-training every day after surgery, and an interactive healthcare web platform for health education.
Receives: Behavioral: RehabLung mobile application; Other: Healthcare interactive Web Platform
Usual care groupActive comparatorThe usual care group will receive standard postoperative care, including chest rehabilitation and an interactive healthcare web platform for health education
Receives: Behavioral: Lung cancer postoperative standard care; Other: Healthcare interactive Web Platform

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8

  2. 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.

    Measured: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8

  3. 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).

    Measured: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8

  4. 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.

    Measured: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8

  5. Pulmoanry function

    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.

    Measured: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8

Secondary outcomes (5)
  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]).

    Measured: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8

  2. 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.

    Measured: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8

  3. 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,

    Measured: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8

  4. 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.

    Measured: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8

  5. Qulaity of life-WHOQOL-BREF

    The measurement of quality of life in participants is assessed using the WHOQOL-BREF questionnaire (World Health Organization Quality of Life Brief Version). This questionnaire includes 26 items that assess perceptions of quality of life across physical, psychological, social, and environmental domains, with scores ranging from 0 to 100. Higher scores indicate better quality of life.

    Measured: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06600503
Sponsor's protocol ID
A-ER-111-055
Status last verified
Sep 2024
First submitted
10 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD sharing plan will be decided after summarized data being published.

Publications

  • Yang HL, Hung CH, Huang YT, Cheng HC, Tseng YL, Su JM, Tsai KL. The effectiveness of the AI-based RehabLung mobile rehabilitation system on cardiopulmonary function and user satisfaction in lung cancer patients undergoing thoracic surgery: a protocol for a two-arm randomized clinical trial. Ther Adv Respir Dis. 2026 Jan-Dec;20:17534666261427319. doi: 10.1177/17534666261427319. Epub 2026 Feb 28.

    PubMed 41762649

Questions about this trial

What is this clinical trial studying?

A study testing RehabLung mobile application and Healthcare interactive Web Platform in people with Pulmonary Rehabilitation and Telerehabilitation, run by National Cheng Kung University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kun-Ling Tsai, Ph.D. (886-6-2353535 ext. 6219, kunlingtsai@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exercise capacity-oxygen consumption (time frame: Baseline, post-surgery assessment at week 5, follow-up assessment at week 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06600503, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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