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| ID | Type | Description | Link |
|---|---|---|---|
| INV23-1479 | Other Identifier | KCE Trials | |
| S68174 | Other Identifier | UZ/KU Leuven |
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| Name | Class |
|---|---|
| Hopitaux Iris Sud | UNKNOWN |
| Centre Hospitalier Universitaire Saint Pierre | OTHER |
| Onze Lieve Vrouw Hospital | OTHER |
| AZ Delta |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome (all-cause hospital readmission or mortality) | within 180 days after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome (all-cause hospital readmission or mortality) | Occurrence | within 90 days after hospital discharge |
| Time-to-composite outcome (all-cause hospital readmission or mortality) | Time-to-event |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive care unit admission | Number of days post-discharge | Day 90, 180, 365 after hospital discharge |
| Lung function: Diffusion capacity | Mean of 2 acceptable assessments |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marine Van Hollebeke, PhD | Contact | 0032498606820 | marine.vanhollebeke@kuleuven.be | |
| Daniel Langer, PhD | Contact | 0032 16 37 64 97 | daniel.langer@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Langer, PhD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZORG | Recruiting | Aalst | 9300 | Belgium |
At this time, there are no plans to share individual participant data (IPD). De-identified participant-level data will not be made publicly available. However, summary results of the trial will be published in peer-reviewed journals and presented at scientific meetings. Researchers interested in secondary analyses may contact the sponsor (UZ Leuven) to discuss possibilities for collaborative projects, subject to approval by the Trial Steering Committee and compliance with applicable regulations and GDPR.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000067251 | Symptom Flare Up |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| OTHER |
| University Hospital, Antwerp | OTHER |
| Algemeen Ziekenhuis Maria Middelares | OTHER |
| Grand Hôpital de Charleroi | OTHER |
| Centre Hospitalier Universitaire UCLouvain Namur | OTHER |
| Centre Hospitalier Universitaire de Liege | OTHER |
| General Hospital Groeninge | OTHER |
| University Hospital, Ghent | OTHER |
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|
| 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 | Number of days post-discharge | Day 90 and 180 after hospital discharge |
| Re-exacerbation |
| Day 90 and 180 after hospital discharge |
| Change in Forced Expiratory Volume in 1 Second (FEV₁), liters | - Mean change in FEV₁ (liters) from baseline, measured by spirometry, according to ATS/ERS guidelines. | Day 90 and 180 after hospital discharge |
| Change in Forced Expiratory Volume in 1 Second (FEV₁), %pred | - Mean change in FEV₁ (% predicted) from baseline, measured by spirometry. | Day 90 and 180 after hospital discharge |
| Change in Forced Vital Capacity (FVC), liters | - Mean change in FVC (liters) from baseline, measured by spirometry. | Day 90 and Day 180 after hospital discharge |
| Change in Forced Vital Capacity (FVC), %predicted | - Mean change in FVC (% predicted) from baseline, measured by spirometry. | Day 90 and Day 180 after hospital discharge |
| Change in FEV₁/FVC Ratio (%) | Mean change in the ratio of FEV₁ to FVC (percentage) from baseline, measured by spirometry. | Day 90 and Day 180 after hospital discharge |
| Change in Functional Residual Capacity (FRC), liters | - Mean change in FRC (liters) from baseline, measured by body plethysmography. | Day 180 after hospital discharge |
| Change in Functional Residual Capacity (FRC), %predicted | - Mean change in FRC (% predicted) from baseline, measured by body plethysmography. | Day 180 after hospital discharge |
| Change in Residual Volume (RV), liters | - Mean change in RV (liters) from baseline, measured by body plethysmography. | Day 180 after hospital discharge |
| Change in Residual Volume (RV), % predicted | - Mean change in RV (% predicted) from baseline, measured by body plethysmography. | Day 180 after hospital discharge |
| Change in Total Lung Capacity (TLC), liters | - Mean change in TLC (liters) from baseline, measured by body plethysmography. | Day 180 after hospital discharge |
| Change in Total Lung Capacity (TLC), %predicted | - Mean change in TLC (% predicted) from baseline, measured by body plethysmography. | Day 180 after hospital discharge |
| Maximal inspiratory pressure (PImax) | Change from baseline | Day 90 and 180 after hospital discharge |
| Baseline/Transition Dyspnea Index (BDI/TDI) | Change from baseline | Day 28, 90, 180 after hospital discharge |
| EQ-5D-5L questionnaire | Change from baseline | Day 28, 90, 180 after hospital discharge |
| COPD Assessment test (CAT) | Change from baseline | Day 28, 90, 180 after hospital discharge |
| Adverse events |
| Day 90, 180 after hospital discharge |
| Serious adverse events |
| Day 90 and 180 after hospital discharge |
| Day 180 after hospital discharge |
| 1 minute sit-to-stand test, Repetitions from Baseline | Mean change in the number of repetitions completed in the 1-minute sit-to-stand test compared with baseline. | Day 180 after hospital discharge |
| Number of Participants Achieving the Minimal Important Difference (MID) in the 1-Minute Sit-to-Stand Test | Number of participants who improved their 1-minute sit-to-stand repetitions by more than the minimal important difference (MID) | Day 180 after hospital discharge |
| Hospital Anxiety & Depression Scale (HADS) | Change from baseline | Day 90 and 180 after hospital discharge |
| EQ-5D-5L | Change from baseline | Day 365 after hospital discharge |
| COPD Assessment test (CAT) | Change from baseline | Day 365 after hospital discharge |
| Baseline/Transition Dyspnea Index (BDI/TDI) | Change from baseline | Day 365 after hospital discharge |
| Hospital re-admission | Time to event | Day 365 after hospital discharge |
| All-cause mortality |
| Day 365 after hospital discharge |
| Rate of AECOPD treated with systemic corticosteroids |
| Day 90, 180, 365 after hospital discharge |
| Rate of AECOPD treated with antibiotics |
| Day 90, 180, 365 after hospital discharge |
| Campus Joseph Bracops, Hôpitaux Iris Sud | Recruiting | Anderlecht | 1070 | Belgium |
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| Centre Hospitalier Universitaire Saint-Pierre | Recruiting | Brussels | 1000 | Belgium |
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| Grand Hopial de Charleroi | Recruiting | Charleroi | 6000 | Belgium |
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| Universitair Ziekenhuis Antwerpen | Not yet recruiting | Edegem | 2650 | Belgium |
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| AZ Maria Middelares | Recruiting | Ghent | 9000 | Belgium |
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| Universitair Ziekenhuis Gent | Recruiting | Ghent | 9000 | Belgium |
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| AZ Groeninge | Recruiting | Kortrijk | 8500 | Belgium |
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| University Hospitals Leuven | Recruiting | Leuven | 3000 | Belgium |
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| Centre hospitalier universitaire de Liège | Recruiting | Liège | 4000 | Belgium |
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| AZ Delta | Recruiting | Roeselare | 8800 | Belgium |
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| Centre Hospitalier Universitaire UCL Namur | Recruiting | Yvoir | 5530 | Belgium |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012008 | Recurrence |