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Recruiting NCT07213128

Effect of IMT in Patients After Acute Exacerbations of COPD

No phase Interventional Chronic Obstructive Pulmonary Diseases COPD Symptom Exacerbation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Training.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Diseases, COPD, Symptom Exacerbation. Basic parameters: from 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of Home-based Inspiratory Muscle Training Compared to Usual Care on Readmission Rate in Patients After a Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Randomised, Multicentre, Parallel Group Clinical Trial: IN-SPIRED Trial

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.

Interventions

  • Other Training
    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 IM

Primary outcome measures

  • Composite outcome (all-cause hospital readmission or mortality) [Time frame: within 180 days after hospital discharge]
Secondary outcome measures (12)
  • Composite outcome (all-cause hospital readmission or mortality) [Time frame: within 90 days after hospital discharge]
  • Time-to-composite outcome (all-cause hospital readmission or mortality) [Time frame: within 180 days after hospital discharge]
  • Hospital re-admission [Time frame: Day 28, 90 and 180 after hospital discharge]
  • All-cause mortality [Time frame: Day 28, 90 and 180 after hospital discharge]
  • Primary care and specialty consultationsc [Time frame: Day 90 and 180 after hospital discharge]
  • Re-exacerbation [Time frame: Day 90 and 180 after hospital discharge]
  • Change in Forced Expiratory Volume in 1 Second (FEV₁), liters [Time frame: Day 90 and 180 after hospital discharge]
  • Change in Forced Expiratory Volume in 1 Second (FEV₁), %pred [Time frame: Day 90 and 180 after hospital discharge]
  • Change in Forced Vital Capacity (FVC), liters [Time frame: Day 90 and Day 180 after hospital discharge]
  • Change in Forced Vital Capacity (FVC), %predicted [Time frame: Day 90 and Day 180 after hospital discharge]
  • Change in FEV₁/FVC Ratio (%) [Time frame: Day 90 and Day 180 after hospital discharge]
  • Change in Functional Residual Capacity (FRC), liters [Time frame: Day 180 after hospital discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 12 centers
  • AZORG — Aalst
  • Campus Joseph Bracops, Hôpitaux Iris Sud — Anderlecht
  • Centre Hospitalier Universitaire Saint-Pierre — Brussels
  • Grand Hopial de Charleroi — Charleroi
  • Universitair Ziekenhuis Antwerpen — Edegem
  • AZ Maria Middelares — Ghent
  • Universitair Ziekenhuis Gent — Ghent
  • AZ Groeninge — Kortrijk
  • … and 4 more centers

Identifiers

NCT: NCT07213128 · S68174 · INV23-1479 · S68174

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗