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Completed
NCT07455552
Smartphone-based Telerehabilitation Versus Home-based Inspiratory Muscle Training After Lung Resection in High-risk Patients: a Pilot Study
Conditions: Pulmonary Disease, Lung Cancer (Diagnosis)
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 58
Sponsor: Pusan National University Hospital
Location: PusanNUH Pusan
Summary
The goal of this pilot clinical trial is to assess the feasibility of smartphone-based telerehabilitation for inspiratory muscle training (IMT) and to explore its preliminary effects on 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:
Is smartphone-based telerehabilitation for IMT feasible and safe in this patient population? Does smartphone-based telerehabilitation for IMT show preliminary effects on functional exercise capacity, as measured by the 6-minute walk test (6MWT)? 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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07455552). StuddyBuddy aggregates publicly available trial information.