Effect of IMT in Patients After Acute Exacerbations of COPD

Not Applicable

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Diseases; COPD; Symptom Exacerbation

• Registration Number: NCT07213128
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-09-15
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-01
• Last Update Submitted: 2025-10-01
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Study Start: 2025-12-01
• Primary Completion: 2028-06
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 358

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite outcome (all-cause hospital readmission or mortality)	within 180 days after hospital discharge

Secondary Outcome Measures

Name	Time	Method
Composite outcome (all-cause hospital readmission or mortality)	within 90 days after hospital discharge	Occurrence
Time-to-composite outcome (all-cause hospital readmission or mortality)	within 180 days after hospital discharge	Time-to-event
Hospital re-admission	Day 28, 90 and 180 after hospital discharge	1. Occurrence; 2. Reason
All-cause mortality	Day 28, 90 and 180 after hospital discharge	1. Occurrence; 2. Reason
Primary care and specialty consultationsc	Day 90 and 180 after hospital discharge	Number of days post-discharge
Re-exacerbation	Day 90 and 180 after hospital discharge	1. Occurrence; 2. Number of occurrences/patient post-discharge
Change in Forced Expiratory Volume in 1 Second (FEV₁), liters	Day 90 and 180 after hospital discharge	\- Mean change in FEV₁ (liters) from baseline, measured by spirometry, according to ATS/ERS guidelines.
Change in Forced Expiratory Volume in 1 Second (FEV₁), %pred	Day 90 and 180 after hospital discharge	\- Mean change in FEV₁ (% predicted) from baseline, measured by spirometry.
Change in Forced Vital Capacity (FVC), liters	Day 90 and Day 180 after hospital discharge	\- Mean change in FVC (liters) from baseline, measured by spirometry.
Change in Forced Vital Capacity (FVC), %predicted	Day 90 and Day 180 after hospital discharge	\- Mean change in FVC (% predicted) from baseline, measured by spirometry.
Change in FEV₁/FVC Ratio (%)	Day 90 and Day 180 after hospital discharge	Mean change in the ratio of FEV₁ to FVC (percentage) from baseline, measured by spirometry.
Change in Functional Residual Capacity (FRC), liters	Day 180 after hospital discharge	\- Mean change in FRC (liters) from baseline, measured by body plethysmography.
Change in Functional Residual Capacity (FRC), %predicted	Day 180 after hospital discharge	\- Mean change in FRC (% predicted) from baseline, measured by body plethysmography.
Change in Residual Volume (RV), liters	Day 180 after hospital discharge	\- Mean change in RV (liters) from baseline, measured by body plethysmography.
Change in Residual Volume (RV), % predicted	Day 180 after hospital discharge	\- Mean change in RV (% predicted) from baseline, measured by body plethysmography.
Change in Total Lung Capacity (TLC), liters	Day 180 after hospital discharge	\- Mean change in TLC (liters) from baseline, measured by body plethysmography.
Change in Total Lung Capacity (TLC), %predicted	Day 180 after hospital discharge	\- Mean change in TLC (% predicted) from baseline, measured by body plethysmography.
Maximal inspiratory pressure (PImax)	Day 90 and 180 after hospital discharge	Change from baseline
Baseline/Transition Dyspnea Index (BDI/TDI)	Day 28, 90, 180 after hospital discharge	Change from baseline
EQ-5D-5L questionnaire	Day 28, 90, 180 after hospital discharge	Change from baseline
COPD Assessment test (CAT)	Day 28, 90, 180 after hospital discharge	Change from baseline
Adverse events	Day 90, 180 after hospital discharge	1. Occurrence; 2. Number of occurrences/patient post-discharge
Serious adverse events	Day 90 and 180 after hospital discharge	1. Occurrence; 2. Number of occurrences/patient post-discharge

Trial Locations

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

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