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Effect of IMT in Patients After Acute Exacerbations of COPD

Study acronym: IN-SPIRED
StatusRecruiting
PhaseNot applicable
SponsorKU Leuven
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 12 sitesv6
  2. Site details revised at 2 of 12 sitesv5
  3. Site details revised at 5 of 12 sitesv4
  4. Site details revised at 2 of 12 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2025 to Jan 6, 2026
    • Site details revised at 12 of 12 sites
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
KU Leuven
69 trials monitored
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COPD
1,119 trials monitored
See 34 trials at risk
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.
Trial Details
NCT Number NCT07213128
Lead Sponsor KU Leuven
Collaborators: Hopitaux Iris Sud, Centre Hospitalier Universitaire Saint Pierre, Onze Lieve Vrouw Hospital, AZ Delta, University Hospital, Antwerp, Algemeen Ziekenhuis Maria Middelares, Grand Hôpital de Charleroi, Centre Hospitalier Universitaire UCLouvain Namur, Centre Hospitalier Universitaire de Liege, General Hospital Groeninge, University Hospital, Ghent
Conditions
(from sponsor)		 Chronic Obstructive Pulmonary Diseases, COPD, Symptom Exacerbation
Related terms Pulmonary Disease, Chronic Obstructive, Symptom Flare Up
Enrollment 358 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov