Effect of IMT in Patients After Acute Exacerbations of COPD

NCT07213128 | Recruiting

• 2 other identifiers: S68174INV23-1479
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

COPD; Chronic Obstructive Pulmonary Diseases; Symptom Exacerbation

Keywords

Inspiratory muscle training; Respiratory muscle training; acute exacerbation; chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

• Composite outcome (all-cause hospital readmission or mortality)

  within 180 days after hospital discharge

Secondary Outcomes (23)

• Composite outcome (all-cause hospital readmission or mortality)

  within 90 days after hospital discharge

• Time-to-composite outcome (all-cause hospital readmission or mortality)

  within 180 days after hospital discharge

• Hospital re-admission

  Day 28, 90 and 180 after hospital discharge

• All-cause mortality

  Day 28, 90 and 180 after hospital discharge

• Primary care and specialty consultationsc

  Day 90 and 180 after hospital discharge

Other Outcomes (12)

• Intensive care unit admission

  Day 90, 180, 365 after hospital discharge

• Lung function: Diffusion capacity

  Day 180 after hospital discharge

• 1 minute sit-to-stand test, Repetitions from Baseline

  Day 180 after hospital discharge

Study Arms (2)

Intervention

EXPERIMENTAL

Other: Training

Control

NO INTERVENTION

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.

Interventions

Training OTHER

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.

Intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KU Leuven: lead
• Hopitaux Iris Sud: collaborator
• Centre Hospitalier Universitaire Saint Pierre: collaborator
• Onze Lieve Vrouw Hospital: collaborator
• AZ Delta: collaborator
• University Hospital, Antwerp: collaborator
• Algemeen Ziekenhuis Maria Middelares: collaborator
• Grand Hôpital de Charleroi: collaborator
• Centre Hospitalier Universitaire UCLouvain Namur: collaborator
• Centre Hospitalier Universitaire de Liege: collaborator
• General Hospital Groeninge: collaborator
• University Hospital, Ghent: collaborator

Study Sites (12)

AZORG

Aalst, 9300, Belgium

RECRUITING

Campus Joseph Bracops, Hôpitaux Iris Sud

Anderlecht, 1070, Belgium

RECRUITING

Centre Hospitalier Universitaire Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

Grand Hopial de Charleroi

Charleroi, 6000, Belgium

RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

NOT YET RECRUITING

AZ Maria Middelares

Ghent, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

AZ Groeninge

Kortrijk, 8500, Belgium

RECRUITING

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

Centre hospitalier universitaire de Liège

Liège, 4000, Belgium

RECRUITING

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

Centre Hospitalier Universitaire UCL Namur

Yvoir, 5530, Belgium

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Symptom Flare Up

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Recurrence

Study Officials

• Daniel Langer, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marine Van Hollebeke, PhD

CONTACT

0032498606820; marine.vanhollebeke@kuleuven.be

Daniel Langer, PhD

CONTACT

0032 16 37 64 97; daniel.langer@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor Faculty of Movement and Rehabilitation Sciences

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 8, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (12)