Home-based inspiratory muscle training after an acute COPD flare
The Effect of Home-based Inspiratory Muscle Training Compared to Usual Care on Readmission Rate in Patients After a Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Randomised, Multicentre, Parallel Group Clinical Trial: IN-SPIRED Trial
This study will test whether adding a home-based inspiratory muscle training program to usual care can reduce 180-day hospital readmissions or death and improve breathing, symptoms, and function in adults recovering from a severe COPD exacerbation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 358 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 12 sites (Aalst and 11 other locations) |
| Trial ID | NCT07213128 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial compares home-based inspiratory muscle training (IMT) plus usual care versus usual care alone in patients hospitalized for at least three days with an acute COPD exacerbation. The IMT program is delivered at home using a tele-monitoring smartphone app and scheduled video contacts to guide and record training sessions. The primary outcome is all-cause hospital readmission or death within 180 days after discharge, with secondary outcomes including respiratory muscle strength, dyspnea, quality of life, and functional capacity. Key eligibility includes age ≥35, ability to consent, possession of a compatible smartphone, and fluency in French, Dutch, or English, while exclusions include prior IMT use, non-COPD primary lung disease, limited life expectancy, or inability to perform the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults (≥35 years) recently hospitalized ≥3 days for an acute COPD exacerbation who can consent, speak French/Dutch/English, and use a compatible smartphone for the tele-monitored IMT program.
Not a fit: Patients already performing IMT, those with a non-COPD primary lung diagnosis, very limited life expectancy, inability to perform IMT or use the app, or those listed for lung transplant or in competing interventional COPD trials are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the program could reduce 180-day readmissions and deaths and improve breathing strength, symptoms, and daily functioning for people recovering from severe COPD flares.
How similar studies have performed: Previous studies show IMT can improve respiratory muscle strength, dyspnea, and exercise capacity in COPD, but high-quality evidence that home-based IMT reduces hospital readmissions or mortality after severe exacerbations is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aalst and 11 other locations
- 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 (Not_yet_recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
- Centre Hospitalier Universitaire UCL Namur — Yvoir, Belgium (Recruiting)
Study contacts
- Principal investigator: Daniel Langer, PhD — KU Leuven
- Study coordinator: Marine Van Hollebeke, PhD
- Email: marine.vanhollebeke@kuleuven.be
- Phone: 0032498606820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.