RecruitingNot ApplicableNCT07213128

Effect of IMT in Patients After Acute Exacerbations of COPD

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


Sponsor

KU Leuven

Enrollment

358 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 35 Years

Inclusion Criteria5

  • 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 Criteria11

  • 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.

Interventions

OTHERTraining

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.


Locations(12)

AZORG

Aalst, Belgium

Campus Joseph Bracops, Hôpitaux Iris Sud

Anderlecht, Belgium

Centre Hospitalier Universitaire Saint-Pierre

Brussels, Belgium

Grand Hopial de Charleroi

Charleroi, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

AZ Maria Middelares

Ghent, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

AZ Groeninge

Kortrijk, Belgium

University Hospitals Leuven

Leuven, Belgium

Centre hospitalier universitaire de Liège

Liège, Belgium

AZ Delta

Roeselare, Belgium

Centre Hospitalier Universitaire UCL Namur

Yvoir, Belgium

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NCT07213128


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