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NCT Number: NCT07213128

Effect of IMT in Patients After Acute Exacerbations of COPD

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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Key information

Conditions

Chronic Obstructive Pulmonary Diseases COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Recurrence Respiratory Tract Diseases Symptom Exacerbation Symptom Flare Up

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZORG, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • 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.

Primary outcomes

  1. Composite outcome (all-cause hospital readmission or mortality)

    Time frame: within 180 days after hospital discharge

Secondary outcomes

  1. Composite outcome (all-cause hospital readmission or mortality)

    Time frame: within 90 days after hospital discharge

    Occurrence

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

    Time frame: within 180 days after hospital discharge

    Time-to-event

  3. Hospital re-admission

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

    • Occurrence
    • Reason

  4. All-cause mortality

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

    • Occurrence
    • Reason

  5. Primary care and specialty consultationsc

    Time frame: Day 90 and 180 after hospital discharge

    Number of days post-discharge

  6. Re-exacerbation

    Time frame: Day 90 and 180 after hospital discharge

    • Occurrence
    • Number of occurrences/patient post-discharge

  7. Change in Forced Expiratory Volume in 1 Second (FEV₁), liters

    Time frame: Day 90 and 180 after hospital discharge

    • Mean change in FEV₁ (liters) from baseline, measured by spirometry, according to ATS/ERS guidelines.

  8. Change in Forced Expiratory Volume in 1 Second (FEV₁), %pred

    Time frame: Day 90 and 180 after hospital discharge

    • Mean change in FEV₁ (% predicted) from baseline, measured by spirometry.

  9. Change in Forced Vital Capacity (FVC), liters

    Time frame: Day 90 and Day 180 after hospital discharge

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

  10. Change in Forced Vital Capacity (FVC), %predicted

    Time frame: Day 90 and Day 180 after hospital discharge

    • Mean change in FVC (% predicted) from baseline, measured by spirometry.

  11. Change in FEV₁/FVC Ratio (%)

    Time frame: Day 90 and Day 180 after hospital discharge

    Mean change in the ratio of FEV₁ to FVC (percentage) from baseline, measured by spirometry.

  12. Change in Functional Residual Capacity (FRC), liters

    Time frame: Day 180 after hospital discharge

    • Mean change in FRC (liters) from baseline, measured by body plethysmography.

  13. Change in Functional Residual Capacity (FRC), %predicted

    Time frame: Day 180 after hospital discharge

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

  14. Change in Residual Volume (RV), liters

    Time frame: Day 180 after hospital discharge

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

  15. Change in Residual Volume (RV), % predicted

    Time frame: Day 180 after hospital discharge

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

  16. Change in Total Lung Capacity (TLC), liters

    Time frame: Day 180 after hospital discharge

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

  17. Change in Total Lung Capacity (TLC), %predicted

    Time frame: Day 180 after hospital discharge

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

  18. Maximal inspiratory pressure (PImax)

    Time frame: Day 90 and 180 after hospital discharge

    Change from baseline

  19. Baseline/Transition Dyspnea Index (BDI/TDI)

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

    Change from baseline

  20. EQ-5D-5L questionnaire

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

    Change from baseline

  21. COPD Assessment test (CAT)

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

    Change from baseline

  22. Adverse events

    Time frame: Day 90, 180 after hospital discharge

    • Occurrence
    • Number of occurrences/patient post-discharge

  23. Serious adverse events

    Time frame: Day 90 and 180 after hospital discharge

    • Occurrence
    • Number of occurrences/patient post-discharge

Other outcomes

  1. Intensive care unit admission

    Time frame: Day 90, 180, 365 after hospital discharge

    Number of days post-discharge

  2. Lung function: Diffusion capacity

    Time frame: Day 180 after hospital discharge

    Mean of 2 acceptable assessments

  3. 1 minute sit-to-stand test, Repetitions from Baseline

    Time frame: Day 180 after hospital discharge

    Mean change in the number of repetitions completed in the 1-minute sit-to-stand test compared with baseline.

  4. Number of Participants Achieving the Minimal Important Difference (MID) in the 1-Minute Sit-to-Stand Test

    Time frame: Day 180 after hospital discharge

    Number of participants who improved their 1-minute sit-to-stand repetitions by more than the minimal important difference (MID)

  5. Hospital Anxiety & Depression Scale (HADS)

    Time frame: Day 90 and 180 after hospital discharge

    Change from baseline

  6. EQ-5D-5L

    Time frame: Day 365 after hospital discharge

    Change from baseline

  7. COPD Assessment test (CAT)

    Time frame: Day 365 after hospital discharge

    Change from baseline

  8. Baseline/Transition Dyspnea Index (BDI/TDI)

    Time frame: Day 365 after hospital discharge

    Change from baseline

  9. Hospital re-admission

    Time frame: Day 365 after hospital discharge

    Time to event

  10. All-cause mortality

    Time frame: Day 365 after hospital discharge

    • Time to event
    • Reason

  11. Rate of AECOPD treated with systemic corticosteroids

    Time frame: Day 90, 180, 365 after hospital discharge

    • Occurrence
    • Time to event

  12. Rate of AECOPD treated with antibiotics

    Time frame: Day 90, 180, 365 after hospital discharge

    • Occurrence
    • Time to event

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Langer, PhD

CONTACT

[email protected]

0032 16 37 64 97

Marine Van Hollebeke, PhD

CONTACT

[email protected]

0032498606820

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • AZ Delta
  • Algemeen Ziekenhuis Maria Middelares
  • Centre Hospitalier Universitaire Saint Pierre
  • Centre Hospitalier Universitaire UCLouvain Namur
  • Centre Hospitalier Universitaire de Liege
  • General Hospital Groeninge
  • Grand Hôpital de Charleroi
  • Hopitaux Iris Sud
  • Onze Lieve Vrouw Hospital
  • University Hospital, Antwerp
  • University Hospital, Ghent

Registry information

Official study 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

Acronym: IN-SPIRED

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Oct 8, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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