RecruitingNot ApplicableNCT07213128

Effect of IMT in Patients After Acute Exacerbations of COPD

The Effect of Home-based Inspiratory Muscle Training Compared to Usual Care on Readmission Rate in Patients After a Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Randomised, Multicentre, Parallel Group Clinical Trial: IN-SPIRED Trial


Sponsor

KU Leuven

Enrollment

358 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to test whether home-based inspiratory muscle training can reduce hospital readmissions and death in patients recovering from a severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The main questions this study aims to answer are: Does adding home-based inspiratory muscle training to usual care lower the risk of all-cause hospital readmission or death within 180 days after discharge? Does inspiratory muscle training improve respiratory muscle strength, symptoms of dyspnea, quality of life, and functional capacity compared to usual care? Researchers will compare patients randomized to: Intervention group: Home-based inspiratory muscle training plus usual care Control group: Usual care only to see if inspiratory muscle training leads to fewer readmissions and deaths, and better patient-reported and physiological outcomes. Participants will: Be hospitalized for ≥3 days due to AECOPD, age ≥35 years, able to consent, and own a compatible smartphone. In the intervention group, receives usual care and additionally inspiratory muscle training: Inspiratory muscle training twice daily for 90 days, then once daily up to day 180, with remote telemonitoring via a smartphone app and online supervised sessions. The control group will continue with usual care (pharmacological treatment, smoking cessation advice, vaccinations, and referral to pulmonary rehabilitation if available). Follow-up assessments will include hospital readmissions, survival, and quality of life questionnaires up to 12 months after discharge.


Eligibility

Min Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether breathing muscle training (called inspiratory muscle training, or IMT) using an app and smartphone can help people recover better after a serious flare-up of COPD (chronic obstructive pulmonary disease, a lung condition). The program is done at home using a smartphone. **You may be eligible if...** - You have been hospitalized for at least 3 days due to a COPD flare-up - You are 35 years old or older - You speak French, Dutch, or English - You own a compatible smartphone and can participate in video meetings **You may NOT be eligible if...** - You are already doing this type of breathing muscle training - Your life expectancy is less than 90 days - Your main lung diagnosis is something other than COPD - You have an active cancer, unstable heart problems, or a collapsed lung - You are waitlisted for a lung transplant or scheduled for lung volume reduction surgery soon - You are already in an in-hospital rehabilitation program or another COPD trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTraining

home-based inspiratory muscle training (IMT) will be delivered using a portable IMT device connected via Bluetooth to a smartphone application that provides real-time feedback, adherence monitoring, and telemonitoring by the study team. Patients will train for 365 days following hospital discharge due to an acute exacerbation of COPD: * Intensive phase (Day 0-90): 2 daily sessions, each consisting of 30 breaths against an inspiratory load set by thetelemonitor, with regular online supervised IMT sessions, 7 sessions in total * Maintenance phase (Day 91-180): One daily session of 30 breaths, with sporadic online supervised IMT sessions, 2 sessions in total. * Follow-up phase (Day 181-365): Participants may continue IMT unsupervised. Supervision includes both in-person sessions at hospital visits and online sessions with telemonitors.


Locations(12)

AZORG

Aalst, Belgium

Campus Joseph Bracops, Hôpitaux Iris Sud

Anderlecht, Belgium

Centre Hospitalier Universitaire Saint-Pierre

Brussels, Belgium

Grand Hopial de Charleroi

Charleroi, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

AZ Maria Middelares

Ghent, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

AZ Groeninge

Kortrijk, Belgium

University Hospitals Leuven

Leuven, Belgium

Centre hospitalier universitaire de Liège

Liège, Belgium

AZ Delta

Roeselare, Belgium

Centre Hospitalier Universitaire UCL Namur

Yvoir, Belgium

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NCT07213128


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