NCT07455552

Comparison of Telemedicine-based and Home-based Inspiratory Muscle Training After Lung Resection in High-risk Patients

Comparison of Postoperative Telemedicine-based Inspiratory Muscle Training and Unsupervised Home-based Training for High-risk Patients Following Lung Resection: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Pusan National University Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effectiveness of remote inspiratory muscle training (IMT) after surgery in high-risk patients undergoing pulmonary lobectomy, using a randomized controlled trial design.

Detailed description

Eligible patients scheduled for pulmonary lobectomy will first be screened during their preoperative visit to the Department of Rehabilitation Medicine. Postoperatively, within 7 days after surgery and prior to hospital discharge, informed consent will be obtained and patients 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 visit the hospital outpatient clinic for baseline assessments, including the 6-minute walk test (6MWT), pulmonary function tests (FVC, FEV1, MIP, PCF), handgrip strength, body composition (InBody), EQ-5D, physical activity questionnaire (K-PASE), and Numeric Rating Scale (NRS) for pain. All participants will be instructed to continue the standard pulmonary rehabilitation program initiated during hospitalization (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 reps × 10 sets) for 6 weeks. Training will begin at 20% of postoperative MIP and be adjusted weekly based on tolerance and symptoms, with a goal of 50% MIP and a maximum perceived exertion of level 4 on the Borg Dyspnea Scale. Remote telerehabilitation will be delivered via a mobile messenger (e.g., KakaoTalk), including: Twice weekly adherence and symptom check-ins, Real-time communication with a dedicated physical therapist (response within 24 hours), Biweekly video submissions or video calls to reassess IMT performance and adjust intensity accordingly, Immediate reporting of adverse events (e.g., headache, dyspnea) via message or phone. The control group will also initiate IMT at 20% of postoperative MIP and adjust intensity independently each week without direct supervision. Patients will be advised to reduce the load if unable to complete 10 reps × 10 sets at the increased level. The control group will continue unsupervised home-based IMT for 6 weeks following one-time instruction at Visit 1. Follow-up assessments will be conducted as follows: Visit 2 (Postoperative weeks 8-10): Reassessment of the same parameters as Visit 1 and review of exercise adherence. Visit 3 (Postoperative weeks 14-16): Final evaluation including cardiopulmonary exercise testing (CPET) and outcome measures.

Conditions

• Pulmonary Disease

Interventions

Type	Name	Description
BEHAVIORAL	1:1 telemedicine-based inspiratory muscle training	Participants in this intervention will perform inspiratory muscle training (IMT) at home for 6 weeks (5 days per week, 10 reps × 10 sets per session). Training begins at 20% of postoperative maximal inspiratory pressure (MIP) and is progressively increased to 50%, using Borg Dyspnea Scale level 4 as the upper limit. A physical therapist will provide weekly supervision and feedback via mobile messenger (e.g., KakaoTalk), including training intensity adjustment, exercise adherence checks, and symptom monitoring. Video or phone calls will be used as needed to support proper technique and safe progression.
BEHAVIORAL	home-based inspiratory muscle training	Participants will perform inspiratory muscle training (IMT) independently at home for 6 weeks, following a standardized protocol of 5 sessions per week, with 10 repetitions × 10 sets per session. Training begins at 20% of the participant's postoperative maximal inspiratory pressure (MIP) and may be increased weekly by the participant based on tolerance, with a target of up to 50%. No further involvement from the research team will occur after initial instruction during the postoperative week 2-4 outpatient visit. Participants will adjust the training intensity on their own without external guidance.

Timeline

• Start date: 2024-08-13
• Primary completion: 2025-12-29
• Completion: 2025-12-29
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: South Korea