Smartphone-based Telerehabilitation Versus Home-based Inspiratory Muscle Training After Lung Rese… (NCT07455552) | Clinical Trial Compass
CompletedNot Applicable
Smartphone-based Telerehabilitation Versus Home-based Inspiratory Muscle Training After Lung Resection in High-risk Patients
South Korea58 participantsStarted 2024-08-13
Plain-language 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
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults aged 19 years or older
. Patients who underwent lung resection
. Patients who met at least one of the following high-risk criteria:
. Patients who understood the study procedures and provided written informed consent
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used smartphone-based telerehabilitation after lung resection — since I'm being considered for or have had lung surgery, is remote breathing exercise training something my care team thinks could help my recovery, based on what this pilot study found?
2The main thing this study measured was how far patients could walk in 6 minutes after doing inspiratory muscle training — what does that walking test actually tell us about how well someone's lungs and body are recovering from a resection?
3This was a pilot study, which means it was a smaller, early-stage trial — does that limit how confident we can be in the results, and should I be looking for larger follow-up studies before considering this kind of rehab approach?
4The study focused on 'high-risk patients' after lung resection — how would you determine whether I fall into that category, and does that change what kind of post-surgical rehabilitation you'd recommend for me?
5Since this trial is already completed, is the smartphone-based inspiratory muscle training program it tested something that's available to me now through my care team, or is it still considered experimental?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
6minute walking test
Timeframe: 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).