Effect of IMT in Patients After Acute Exacerbations of COPD

KU Leuven358 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

358

Conditions

Interventions

TrainingOTHER

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.

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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.

Locations (12)

AZORG

Aalst, Belgium

RECRUITING

Campus Joseph Bracops, Hôpitaux Iris Sud

Anderlecht, Belgium

NOT_YET_RECRUITING

Centre Hospitalier Universitaire Saint-Pierre

Brussels, Belgium

NOT_YET_RECRUITING

Grand Hopial de Charleroi

Charleroi, Belgium

NOT_YET_RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

NOT_YET_RECRUITING

AZ Maria Middelares

Ghent, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, Belgium

NOT_YET_RECRUITING

AZ Groeninge

Kortrijk, Belgium

NOT_YET_RECRUITING

University Hospitals Leuven

Leuven, Belgium

RECRUITING

Centre hospitalier universitaire de Liège

Liège, Belgium

NOT_YET_RECRUITING

...and 2 more locations

Outcomes

Primary Outcomes

Composite outcome (all-cause hospital readmission or mortality)

Time frame: within 180 days after hospital discharge

Secondary Outcomes

Composite outcome (all-cause hospital readmission or mortality)

Occurrence

Time frame: within 90 days after hospital discharge

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

Time-to-event

Time frame: within 180 days after hospital discharge

Hospital re-admission

1. Occurrence 2. Reason

Time frame: Day 28, 90 and 180 after hospital discharge

All-cause mortality

1. Occurrence 2. Reason

Time frame: Day 28, 90 and 180 after hospital discharge

Primary care and specialty consultationsc

Number of days post-discharge

Time frame: Day 90 and 180 after hospital discharge

Re-exacerbation

1. Occurrence 2. Number of occurrences/patient post-discharge

Time frame: 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.

Time frame: 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.

Time frame: Day 90 and 180 after hospital discharge

Change in Forced Vital Capacity (FVC), liters

\- Mean change in FVC (liters) from baseline, measured by spirometry.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 180 after hospital discharge

Change in Functional Residual Capacity (FRC), %predicted

\- Mean change in FRC (% predicted) from baseline, measured by body plethysmography.

Time frame: Day 180 after hospital discharge

Change in Residual Volume (RV), liters

\- Mean change in RV (liters) from baseline, measured by body plethysmography.

Time frame: Day 180 after hospital discharge

Change in Residual Volume (RV), % predicted

\- Mean change in RV (% predicted) from baseline, measured by body plethysmography.

Time frame: Day 180 after hospital discharge

Change in Total Lung Capacity (TLC), liters

\- Mean change in TLC (liters) from baseline, measured by body plethysmography.

Time frame: Day 180 after hospital discharge

Change in Total Lung Capacity (TLC), %predicted

\- Mean change in TLC (% predicted) from baseline, measured by body plethysmography.

Time frame: Day 180 after hospital discharge

Maximal inspiratory pressure (PImax)

Change from baseline

Time frame: Day 90 and 180 after hospital discharge

Baseline/Transition Dyspnea Index (BDI/TDI)

Change from baseline

Time frame: Day 28, 90, 180 after hospital discharge

EQ-5D-5L questionnaire

Change from baseline

Time frame: Day 28, 90, 180 after hospital discharge

COPD Assessment test (CAT)

Change from baseline

Time frame: Day 28, 90, 180 after hospital discharge

Adverse events

1. Occurrence 2. Number of occurrences/patient post-discharge

Time frame: Day 90, 180 after hospital discharge

Serious adverse events

1. Occurrence 2. Number of occurrences/patient post-discharge

Time frame: Day 90 and 180 after hospital discharge

Effect of IMT in Patients After Acute Exacerbations of COPD

Overview

Conditions

Interventions

Eligibility

Locations (12)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts