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

NCT07455552 | Completed

• 1 other identifier: 2407-025-140
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer (Diagnosis); Pulmonary Disease

Keywords

Lung Resection; Inspiratory Muscle Training; Telerehabilitation; Postoperative Rehabilitation; High-risk Patients; KakaoTalk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Forced Vital Capacity (FVC)

  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

  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

  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)

  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

  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).

Study Arms (2)

Smartphone-based telerehabilitation IMT

EXPERIMENTAL

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

Unsupervised home-based IMT

ACTIVE COMPARATOR

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

Interventions

Smartphone-based telerehabilitation IMT BEHAVIORAL

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.

Smartphone-based telerehabilitation IMT

Unsupervised home-based IMT BEHAVIORAL

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.

Unsupervised home-based IMT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older
• Patients who underwent lung resection
• Patients who met at least one of the following high-risk criteria:
• preoperative FEV1 or DLCO ≤70% predicted
• age ≥65 years
• Patients who understood the study procedures and provided written informed consent

You may not qualify if:

• Pregnant women or other vulnerable populations considered inappropriate for study participation
• 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)
• Patients with an implanted pacemaker or defibrillator that precluded bioelectrical impedance analysis
• Patients participating in other clinical studies that could affect exercise capacity
• Patients unable to independently use the messenger application (KakaoTalk) after standardized instruction
• Patients judged by the investigator to be unsuitable for participation

Sponsors & Collaborators

• Pusan National University Hospital: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

PusanNUH

Pusan, South Korea

Location

MeSH Terms

Conditions

Lung Diseases; Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanghun Kim, MD,PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized in a 1:1 ratio to either a smartphone-based telerehabilitation IMT group or a self-managed home-based IMT group in a parallel two-arm design.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: March 6, 2026
• Study Start: August 13, 2024
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)