Smartphone-based Telerehabilitation Versus Home-based Inspiratory Muscle Training After Lung Resection in High-risk Patients

Postoperative Smartphone-based Telerehabilitation Versus Unsupervised Home-based Inspiratory Muscle Training in High-risk Patients After Lung Resection: A Randomized Controlled Trial

The goal of this clinical trial is to learn whether smartphone-based telerehabilitation for inspiratory muscle training (IMT) can improve postoperative recovery in high-risk adult patients after lung resection. Eligible participants are adults aged 19 years or older who underwent lung resection and met at least one high-risk criterion: preoperative forced expiratory volume in 1 second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) of 70% predicted or less, or age 65 years or older. The main questions it aims to answer are:

Does smartphone-based telerehabilitation for IMT improve functional exercise capacity, as measured by the 6-minute walk test (6MWT)? Is smartphone-based telerehabilitation for IMT feasible and safe in this patient population?

Researchers will compare smartphone-based telerehabilitation IMT with unsupervised home-based IMT to see whether remote supervision provides additional benefit after lung resection.

Participants will:

be randomized to either smartphone-based telerehabilitation IMT or unsupervised home-based IMT perform IMT 5 days per week for 6 weeks, starting at 20% of postoperative maximal inspiratory pressure (MIP) with progression according to tolerance complete outcome assessments at postoperative weeks 2-4, 8-10, and 14-16, including the 6MWT, pulmonary function tests (FVC, FEV1, MIP, and peak expiratory flow), handgrip strength, body composition, patient-reported outcomes, and cardiopulmonary exercise testing at final follow-up

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease; Lung Cancer (Diagnosis)
• Intervention / Treatment: Behavioral: Smartphone-based telerehabilitation IMT; Behavioral: Unsupervised home-based IMT

Detailed Description

Eligible patients who undergo lung resection will be screened during postoperative hospitalization and before their first outpatient visit to the Department of Rehabilitation Medicine. To be eligible, participants must be adults aged 19 years or older, have undergone lung resection, meet at least one of the following high-risk criteria: preoperative forced expiratory volume in 1 second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) of 70% predicted or less, or age 65 years or older, and be able to understand the study procedures and provide written informed consent. Within 7 days after surgery and before hospital discharge, informed consent will be obtained and participants will be randomized in a 1:1 ratio to either the intervention or control group.

At postoperative weeks 2-4 (Visit 1), both groups will attend an outpatient visit for baseline assessments, including the 6-minute walk test (6MWT), pulmonary function tests (FVC, FEV1, MIP, and peak expiratory flow [PEF]), handgrip strength, body composition (InBody), EQ-5D, the Korean version of the Physical Activity Scale for the Elderly (K-PASE), and the Numeric Rating Scale (NRS) for pain. All participants will be instructed to continue the standard pulmonary rehabilitation program initiated during hospitalization, including breathing exercises, coughing techniques, early ambulation, and low-intensity aerobic exercise.

The intervention group will perform inspiratory muscle training (IMT) 5 days per week (10 repetitions × 10 sets per day) for 6 weeks. Training will begin at 20% of postoperative maximal inspiratory pressure (MIP) and will be adjusted according to tolerance and symptoms, with a target of 50% of postoperative MIP and an upper limit of 4 on the Borg Dyspnea Scale. Smartphone-based telerehabilitation will be delivered through a mobile messenger application (e.g., KakaoTalk) and will include twice-weekly adherence and symptom monitoring, therapist feedback, and remote support for training progression. Communication will primarily be conducted through messaging, with telephone contact used as needed. Participants will also be able to contact the research team to ask questions or report adverse events during the intervention period, and the research team will respond within 24 hours.

The control group will perform the same IMT protocol for 6 weeks after a one-time instruction session at Visit 1, but without additional remote monitoring. Training will also begin at 20% of postoperative MIP, and participants will adjust the intensity independently based on tolerance. They will be instructed to reduce the load if they are unable to complete the prescribed training volume at the increased intensity.

Follow-up assessments will be conducted at postoperative weeks 8-10 (Visit 2) and 14-16 (Visit 3). Visit 2 will include reassessment of the same parameters measured at Visit 1 and review of exercise adherence. Visit 3 will include final outcome assessments and cardiopulmonary exercise testing (CPET).

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Pusan, South Korea
    • PusanNUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged 19 years or older
2. Patients who underwent lung resection

3. Patients who met at least one of the following high-risk criteria:

   • preoperative FEV1 or DLCO ≤70% predicted
   • age ≥65 years
4. Patients who understood the study procedures and provided written informed consent

Exclusion Criteria:

1. Pregnant women or other vulnerable populations considered inappropriate for study participation
2. Patients with limited mobility due to other conditions that could interfere with the exercise stress test or 6-minute walk test (e.g., osteoarthritis, spinal disorders, or cerebral infarction)
3. Patients with an implanted pacemaker or defibrillator that precluded bioelectrical impedance analysis
4. Patients participating in other clinical studies that could affect exercise capacity
5. Patients unable to independently use the messenger application (KakaoTalk) after standardized instruction
6. Patients judged by the investigator to be unsuitable for participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartphone-based telerehabilitation IMT; Participants in this group will perform inspiratory muscle training (IMT) at home for 6 weeks (5 days per week, 10 repetitions × 10 sets per day) with smartphone-based telerehabilitation support. Training will begin at 20% of postoperative maximal inspiratory pressure (MIP) and be adjusted according to tolerance and symptoms, with a target of 50% of postoperative MIP. Support will be delivered through a mobile messenger application (e.g., KakaoTalk) and will include twice-weekly adherence and symptom monitoring, therapist feedback, and remote support for training progression. Telephone contact will be used as needed.	Behavioral: Smartphone-based telerehabilitation IMT; Home-based inspiratory muscle training performed for 6 weeks (5 days per week, 10 repetitions × 10 sets per day), starting at 20% of postoperative maximal inspiratory pressure (MIP) with progression according to tolerance and symptoms. Participants receive smartphone-based telerehabilitation support through a mobile messenger application, including adherence checks, symptom monitoring, therapist feedback, and remote support for training progression.
Active Comparator: Unsupervised home-based IMT; Participants in this group will perform the same inspiratory muscle training (IMT) protocol at home for 6 weeks (5 days per week, 10 repetitions × 10 sets per day) after a one-time instruction session at the postoperative week 2-4 outpatient visit. Training will begin at 20% of postoperative maximal inspiratory pressure (MIP), and participants will adjust the intensity independently based on tolerance, with a target of up to 50% of postoperative MIP. No additional remote monitoring or supervision will be provided after the initial instruction session.	Behavioral: Unsupervised home-based IMT; Home-based inspiratory muscle training performed for 6 weeks (5 days per week, 10 repetitions × 10 sets per day), starting at 20% of postoperative maximal inspiratory pressure (MIP) with progression according to tolerance. After a one-time instruction session, participants continue the training independently without additional remote monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6minute walking test	Total distance walked in meters during a 6-minute walk test performed on a 30-meter flat indoor course to assess functional exercise capacity and postoperative recovery.	Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Vital Capacity (FVC)	Forced vital capacity (FVC) measured using standardized spirometry, reported in liters (L).	Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
FEV1	Forced expiratory volume in 1 second (FEV1) measured using standardized spirometry, reported in liters (L).	Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
MIP	Maximal inspiratory pressure (MIP) measured using standardized spirometry, reported in cmH2O.	Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Peak Expiratory Flow (PEF)	Peak expiratory flow (PEF) measured using standardized spirometry. Participants exhale as forcefully as possible after deep inhalation, and the highest value from three attempts is recorded.	Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Hand grip strength	Handgrip strength measured using a handheld dynamometer. Participants perform three trials with the dominant hand, and the highest value is recorded.	Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Bioelectric Impedance Analysis	Body composition assessed using bioelectrical impedance analysis (InBody S10), including skeletal muscle mass, skeletal muscle index, phase angle, and fat-free mass.	Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Questionnaires (EQ-5D-5L, EQ-VAS, and K-PASE)	Health-related quality of life was assessed using the EQ-5D-5L and EQ visual analogue scale (EQ-VAS). Self-reported physical activity related to leisure, household activities, and work was assessed using the Korean version of the Physical Activity Scale for the Elderly (K-PASE).	Visit 1 (2 to 4 weeks after surgery), Visit 2 (8 to 10 weeks after surgery), and Visit 3 (14 to 16 weeks after surgery).
Cardiopulmonary Exercise Test (CPET)	Cardiopulmonary exercise testing (CPET) performed at final follow-up. Parameters include peak oxygen uptake (VO2 peak), predicted VO2 peak, ventilatory efficiency (VE/VCO2 slope), anaerobic threshold, respiratory exchange ratio, and maximal heart rate.	Visit 3 (14 to 16 weeks after surgery).

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Collaborators: National Research Foundation of Korea
• Investigators: Principal Investigator: Sanghun Kim, MD,PhD, Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2024
• Primary Completion (Actual): December 29, 2025
• Study Completion (Actual): December 29, 2025

Study Registration Dates

• First Submitted: July 9, 2025
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Telerehabilitation; Lung Resection; Inspiratory Muscle Training; Postoperative Rehabilitation; High-risk Patients; KakaoTalk
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Lung Neoplasms; Disease
• Other Study ID Numbers: 2407-025-140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No