Effect of IMT in Patients After Acute Exacerbations of COPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorKU Leuven
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted to the hospital ≥3 days for AECOPD
Read and speak French, Dutch or English
Age ≥ 35 years
Able to provide informed consent
Disqualifiers
Patients already performing IMT at time of inclusion
Patients with estimated <90 days life expectancy
Non-COPD pulmonary disease as primary diagnosis
Active malignancy
Trial design
Design model
Parallel
Treatments tested in this trial
Training
Other interventionhome-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.
Treatment groups
358 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Composite outcome (all-cause hospital readmission or mortality)
Time frame
within 180 days after hospital dischargeSecondary outcomes
1
Composite outcome (all-cause hospital readmission or mortality)
Occurrence
Time frame
within 90 days after hospital discharge2
Time-to-composite outcome (all-cause hospital readmission or mortality)
Time-to-event
Time frame
within 180 days after hospital discharge3
Hospital re-admission
1. Occurrence 2. Reason
Time frame
Day 28, 90 and 180 after hospital discharge4
All-cause mortality
1. Occurrence 2. Reason
Time frame
Day 28, 90 and 180 after hospital dischargeOther outcomes
1
Intensive care unit admission
Number of days post-discharge
Time frame
Day 90, 180, 365 after hospital discharge2
Lung function: Diffusion capacity
Mean of 2 acceptable assessments
Time frame
Day 180 after hospital discharge3
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.
Time frame
Day 180 after hospital discharge4
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)
Time frame
Day 180 after hospital dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
KU Leuven
Lead sponsor
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
Source ClinicalTrials.gov