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Clinical Trials in Belgium / NCT07213128
Recruiting Not applicable

Effect of IMT in Patients After Acute Exacerbations of COPD

NCT07213128 · tracked via the Priya Life Science Belgium tracker
Sponsor
KU Leuven
Phase
Not applicable
Started
2026-01-06
Last updated
2026-05-28

Condition(s) studied

Chronic Obstructive Pulmonary DiseasesCOPDSymptom Exacerbation

Investigational drug(s) / intervention(s)

Training

Training: 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.

Study 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

Sex
ALL
Min age
35 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients admitted to the hospital ≥3 days for AECOPD * Read and speak French, Dutch or English * Age ≥ 35 years * Able to provide informed consent * Possessing a smartphone, compatible with the tele-monitoring app and able to perform video meetings. Exclusion Criteria: * Patients already performing IMT at time of inclusion * Patients with estimated \<90 days life expectancy * Non-COPD pulmonary disease as primary diagnosis * Active malignancy * Inability to perform IMT or response to questionnaires (e.g., neurological/cognitive impairment) * Acute instable cardiac arrythmia or ischemia * Acute pneumothorax * Planned lung volume reduction procedure \<180days * Waitlisted for lung transplantation * Patients admitted to an in-hospital rehabilitation ward * Patients included in other interventional trial related to COPD that would interfere with our trial outcomes.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
AZORG Aalst Belgium Recruiting
Campus Joseph Bracops, Hôpitaux Iris Sud Anderlecht Belgium Recruiting
Centre Hospitalier Universitaire Saint-Pierre Brussels Belgium Recruiting
Grand Hopial de Charleroi Charleroi Belgium Recruiting
Universitair Ziekenhuis Antwerpen Edegem Belgium Not Yet Recruiting
AZ Maria Middelares Ghent Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
AZ Groeninge Kortrijk Belgium Recruiting
University Hospitals Leuven Leuven Belgium Recruiting
Centre hospitalier universitaire de Liège Liège Belgium Recruiting
AZ Delta Roeselare Belgium Recruiting
Centre Hospitalier Universitaire UCL Namur Yvoir Belgium Recruiting

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Other trials for the same condition

Supramaximal High-Intensity Interval Training in People With and Without Chronic Obstructive Pulmonary Disease Recruiting
Biannual Review of Exhaled Air and Trends in Health Evaluation in COPD Recruiting
Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs Enrolling by invitation
Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07213128 on ClinicalTrials.gov ↗ ← All trials in Belgium