Effect of IMT in Patients After Acute Exacerbations of COPD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorKU Leuven

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

358 Participants
are divided into 2 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