Chronic Obstructive Pulmonary Diseases, COPD, Symptom Exacerbation
Conditions
Keywords
Inspiratory muscle training, Respiratory muscle training, acute exacerbation, chronic obstructive pulmonary disease
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.
Interventions
OTHERTraining
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.
Sponsors
KU Leuven
Hopitaux Iris Sud
Centre Hospitalier Universitaire Saint Pierre
Onze Lieve Vrouw Hospital
AZ Delta
University Hospital, Antwerp
Algemeen Ziekenhuis Maria Middelares
Grand Hôpital de Charleroi
Centre Hospitalier Universitaire UCLouvain Namur
Centre Hospitalier Universitaire de Liege
General Hospital Groeninge
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome (all-cause hospital readmission or mortality) | within 180 days after hospital discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Contacts
CONTACTMarine Van Hollebeke, PhD
CONTACTDaniel Langer, PhD
PRINCIPAL_INVESTIGATORDaniel Langer, PhD
KU Leuven
Outcome results
None listed