Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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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

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 35
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
AZORG
RECRUITING
Aalst
Campus Joseph Bracops, Hôpitaux Iris Sud
RECRUITING
Anderlecht
Centre Hospitalier Universitaire Saint-Pierre
RECRUITING
Brussels
Grand Hopial de Charleroi
RECRUITING
Charleroi
Universitair Ziekenhuis Antwerpen
NOT_YET_RECRUITING
Edegem
AZ Maria Middelares
RECRUITING
Ghent
Universitair Ziekenhuis Gent
RECRUITING
Ghent
AZ Groeninge
RECRUITING
Kortrijk
University Hospitals Leuven
RECRUITING
Leuven
Centre hospitalier universitaire de Liège
NOT_YET_RECRUITING
Liège
AZ Delta
RECRUITING
Roeselare
Centre Hospitalier Universitaire UCL Namur
RECRUITING
Yvoir
Contact Information
Primary
Marine Van Hollebeke, PhD
marine.vanhollebeke@kuleuven.be
0032498606820
Backup
Daniel Langer, PhD
daniel.langer@kuleuven.be
0032 16 37 64 97
Time Frame
Start Date: 2026-01-06
Estimated Completion Date: 2029-02
Participants
Target number of participants: 358
Treatments
Experimental: Intervention
No_intervention: Control
Patients will receive usual care, including optimal pharmacological therapy per international guidelines, advise on smoking cessation, vaccination, and physical activity participation and advised to attend physiotherapy or a respiratory rehabilitation program based on accessibility and patient preference.
Sponsors
Collaborators: Centre Hospitalier Universitaire de Liege, AZ Delta, General Hospital Groeninge, Centre Hospitalier Universitaire UCLouvain Namur, Centre Hospitalier Universitaire Saint Pierre, Onze Lieve Vrouw Hospital, Algemeen Ziekenhuis Maria Middelares, Grand Hôpital de Charleroi, University Hospital, Antwerp, University Hospital, Ghent, Hopitaux Iris Sud
Leads: KU Leuven

This content was sourced from clinicaltrials.gov