About this trial
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 criteria
Qualifiers
Patients admitted to the hospital ≥3 days for AECOPD
Read and speak French, Dutch or English
Age ≥ 35 years
Able to provide informed consent
Disqualifiers
Patients already performing IMT at time of inclusion
Patients with estimated <90 days life expectancy
Non-COPD pulmonary disease as primary diagnosis
Active malignancy
Trial design
Treatments tested in this trial
- Training
Treatment groups
Sponsors and collaborators
KU Leuven
Lead sponsor
Hopitaux Iris Sud
Collaborator
Centre Hospitalier Universitaire Saint Pierre
Collaborator
Onze Lieve Vrouw Hospital
Collaborator
AZ Delta
Collaborator
University Hospital, Antwerp
Collaborator
Algemeen Ziekenhuis Maria Middelares
Collaborator
Grand Hôpital de Charleroi
Collaborator
Centre Hospitalier Universitaire UCLouvain Namur
Collaborator
Centre Hospitalier Universitaire de Liege
Collaborator
General Hospital Groeninge
Collaborator
University Hospital, Ghent
Collaborator