NCT07213128 Effect of IMT in Patients After Acute Exacerbations of COPD
| NCT ID | NCT07213128 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KU Leuven |
| Condition | Chronic Obstructive Pulmonary Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 358 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 358 participants in total. It began in 2026-01-06 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Daniel Langer, PhD
PRINCIPAL INVESTIGATOR
KU Leuven
Frequently Asked Questions
Who can join the NCT07213128 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, studying Chronic Obstructive Pulmonary Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07213128 currently recruiting?
Yes, NCT07213128 is actively recruiting participants. Contact the research team at marine.vanhollebeke@kuleuven.be for enrollment information.
Where is the NCT07213128 trial being conducted?
This trial is being conducted at Aalst, Belgium, Anderlecht, Belgium, Brussels, Belgium, Charleroi, Belgium and 8 additional locations.
Who is sponsoring the NCT07213128 clinical trial?
NCT07213128 is sponsored by KU Leuven. The principal investigator is Daniel Langer, PhD at KU Leuven. The trial plans to enroll 358 participants.