RecruitingNot Applicable

Effect of IMT in Patients After Acute Exacerbations of COPD

Belgium358 participantsStarted 2026-01-06

Plain-language 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.

Who can participate

Age range

35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite outcome (all-cause hospital readmission or mortality)

Timeframe: within 180 days after hospital discharge

Trial details

NCT IDNCT07213128

SponsorKU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Marine Van Hollebeke, PhD

0032498606820 marine.vanhollebeke@kuleuven.be

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Diseases trials