Actively Recruiting

Phase Not Applicable
Age: 35Years +
All Genders
NCT07213128

Effect of IMT in Patients After Acute Exacerbations of COPD

Led by KU Leuven · Updated on 2026-04-01

358

Participants Needed

12

Research Sites

160 weeks

Total Duration

On this page

Sponsors

K

KU Leuven

Lead Sponsor

H

Hopitaux Iris Sud

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of IMT in Patients After Acute Exacerbations of COPD

Who Can Participate

Age: 35Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted to the hospital for 3 days or more due to acute exacerbation of COPD
  • Able to read and speak French, Dutch, or English
  • Age 35 years or older
  • Able to provide informed consent
  • Own a smartphone compatible with the tele-monitoring app and able to participate in video meetings
Not Eligible

You will not qualify if you...

  • Currently performing inspiratory muscle training at the time of inclusion
  • Estimated life expectancy less than 90 days
  • Primary diagnosis of a non-COPD pulmonary disease
  • Active cancer
  • Unable to perform inspiratory muscle training or complete questionnaires due to neurological or cognitive impairment
  • Presence of acute unstable cardiac arrhythmia or ischemia
  • Acute pneumothorax
  • Planned lung volume reduction procedure within 180 days
  • Waiting for lung transplantation
  • Admitted to an in-hospital rehabilitation ward
  • Enrolled in another interventional COPD trial that could interfere with this study's outcomes

AI-Screening

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Trial Site Locations

Total: 12 locations

1

AZORG

Aalst, Belgium, 9300

Actively Recruiting

2

Campus Joseph Bracops, Hôpitaux Iris Sud

Anderlecht, Belgium, 1070

Actively Recruiting

3

Centre Hospitalier Universitaire Saint-Pierre

Brussels, Belgium, 1000

Actively Recruiting

4

Grand Hopial de Charleroi

Charleroi, Belgium, 6000

Actively Recruiting

5

Universitair Ziekenhuis Antwerpen

Edegem, Belgium, 2650

Not Yet Recruiting

6

AZ Maria Middelares

Ghent, Belgium, 9000

Actively Recruiting

7

Universitair Ziekenhuis Gent

Ghent, Belgium, 9000

Actively Recruiting

8

AZ Groeninge

Kortrijk, Belgium, 8500

Actively Recruiting

9

University Hospitals Leuven

Leuven, Belgium, 3000

Actively Recruiting

10

Centre hospitalier universitaire de Liège

Liège, Belgium, 4000

Not Yet Recruiting

11

AZ Delta

Roeselare, Belgium, 8800

Actively Recruiting

12

Centre Hospitalier Universitaire UCL Namur

Yvoir, Belgium, 5530

Actively Recruiting

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Research Team

M

Marine Van Hollebeke, PhD

CONTACT

D

Daniel Langer, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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