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

NCT06600503 | Not Yet Recruiting

• 1 other identifier: A-ER-111-055
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.To understand the effectiveness of the pulmonary rehabilitation mobile application in improving lung function.
2. 2.To assess the feasibility of the pulmonary rehabilitation mobile application in post-surgery rehabilitation care.

Conditions

Pulmonary Rehabilitation; Telerehabilitation; Lung Cancer

Keywords

pulmonary rehabilitation; mobile application; Telerehabilitation; Lung cancer

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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.

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

• 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).

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

• 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.

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

• 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.

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

Secondary Outcomes (5)

• 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

Other Outcomes (3)

• Demographic data

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

• Adherence

  Post-surgery assessment will be conducted at week 5, followed by a follow-up assessment at week 8.

• Compliance

  Post-surgery assessment will be conducted at week 5, followed by a follow-up assessment at week 8.

Study Arms (2)

application inttervention group

EXPERIMENTAL

The 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.

Behavioral: RehabLung mobile application; Other: Healthcare interactive Web Platform

Usual care group

ACTIVE COMPARATOR

The usual care group will receive standard postoperative care, including chest rehabilitation and an interactive healthcare web platform for health education

Behavioral: Lung cancer postoperative standard care; Other: Healthcare interactive Web Platform

Interventions

RehabLung mobile application BEHAVIORAL

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.

Also known as: The application group, RehabLung App

application inttervention group

Lung cancer postoperative standard care BEHAVIORAL

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.

Also known as: usual care, Standard chest rehabilitation

Usual care group

Healthcare interactive Web Platform OTHER

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.

Usual care group; application inttervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng Kung University: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Kun-Ling Tsai, Ph.D.

CONTACT

886-6-2353535; kunlingtsai@mail.ncku.edu.tw

Hsin-lun Yang, MS.

CONTACT

886-6-2353535; t66064043@pt.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share