Chronic Obstructive Pulmonary DiseasesIN-SPIREDNCT07213128
Effect of IMT in Patients After Acute Exacerbations of COPD
A study testing Training in people with Chronic Obstructive Pulmonary Diseases and COPD, run by KU Leuven at 12 sites in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Diseases, COPD, Symptom Exacerbation
- What is being tested?
- Training
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 12 sitesBelgium
- Study dates
- 6 Jan 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Belgium12 sites, 12 recruiting
- Recruiting
AZORG
Aalst, 9300
Dimitri Stylemans, 0032 53 72 42 89, dimitri.stylemans@azorg.be
Dimitri Stylemans
- Recruiting
Campus Joseph Bracops, Hôpitaux Iris Sud
Anderlecht, 1070
Emmanuelle Papleux, 0032 2 432 81 71, epapleux@his-izz.be
Olivier Bauwens
- Recruiting
Centre Hospitalier Universitaire Saint-Pierre
Brussels, 1000
Maria Gabrovska, 0032 2 535 42 03, maria.gabrovska@stpierre-bru.be
Maria Gabrovska
- Recruiting
Grand Hopial de Charleroi
Charleroi, 6000
Antoine Fremault, 003260 11 12 13, Antoine.FREMAULT@ghdc.be
Antoine Fremault
- Not yet recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Jo Raskin, 0032 3 821 32 50, Jo.Raskin@uza.be
Jo Raskin
- Recruiting
AZ Maria Middelares
Ghent, 9000
Sarah Loof, 00329 246 84 00, Sarah.Loof@mijnziekenhuis.be
Sarah Loof
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Eric Derom, 0032 9 332 26 72, Eric.Derom@uzgent.be
Eric Derom
- Recruiting
AZ Groeninge
Kortrijk, 8500
Martijn Vandebotermet, 0032 16 33 22 11, MARTIJN.VANDEBOTERMET@azgroeninge.be
Martijn Vandebotermet
- Recruiting
University Hospitals Leuven
Leuven, 3000
Daniel Langer, PhD, 0032 16 37 64 97, daniel.langer@kuleuven.be
Stephanie Everaerts, PhD, stephanie.everaerts@uzleuven.be
- Recruiting
Centre hospitalier universitaire de Liège
Liège, 4000
Vincent Heinen, 0032 2 609 54 95, V.Heinen@chuliege.be
Olivier Bonhomme
- Recruiting
AZ Delta
Roeselare, 8800
Bernard Bouckaert, 003251 69 85 94, bernard.bouckaert@azdelta.be
Bernard Bouckaert
- Recruiting
Centre Hospitalier Universitaire UCL Namur
Yvoir, 5530
Eric Marchand, 0032 81 423361, eric.marchand@chuuclnamur.uclouvain.be
Charlotte SCHLESSER
About this study
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
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:
Read more
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.
- Being tested
- Training
- Keywords
- Inspiratory muscle training, Respiratory muscle training, acute exacerbation, chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Symptom Flare Up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Training |
| Control | No intervention | Patients will receive usual care, including optimal pharmacological therapy per international guidelines, advise on smoking cessation, vaccination, and physical activity participation and advised to attend physiotherapy or a respiratory rehabilitation program based on accessibility and patient preference. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome (all-cause hospital readmission or mortality)
Measured: within 180 days after hospital discharge
Secondary outcomes (23)
Composite outcome (all-cause hospital readmission or mortality)
Occurrence
Measured: within 90 days after hospital discharge
Time-to-composite outcome (all-cause hospital readmission or mortality)
Time-to-event
Measured: within 180 days after hospital discharge
Hospital re-admission
- Occurrence
- Reason
Measured: Day 28, 90 and 180 after hospital discharge
All-cause mortality
- Occurrence
- Reason
Measured: Day 28, 90 and 180 after hospital discharge
Primary care and specialty consultationsc
Number of days post-discharge
Measured: Day 90 and 180 after hospital discharge
Re-exacerbation
- Occurrence
- Number of occurrences/patient post-discharge
Measured: 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.
Measured: 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.
Measured: Day 90 and 180 after hospital discharge
Change in Forced Vital Capacity (FVC), liters
- Mean change in FVC (liters) from baseline, measured by spirometry.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 180 after hospital discharge
Change in Functional Residual Capacity (FRC), %predicted
- Mean change in FRC (% predicted) from baseline, measured by body plethysmography.
Measured: Day 180 after hospital discharge
Change in Residual Volume (RV), liters
- Mean change in RV (liters) from baseline, measured by body plethysmography.
Measured: Day 180 after hospital discharge
Change in Residual Volume (RV), % predicted
- Mean change in RV (% predicted) from baseline, measured by body plethysmography.
Measured: Day 180 after hospital discharge
Change in Total Lung Capacity (TLC), liters
- Mean change in TLC (liters) from baseline, measured by body plethysmography.
Measured: Day 180 after hospital discharge
Change in Total Lung Capacity (TLC), %predicted
- Mean change in TLC (% predicted) from baseline, measured by body plethysmography.
Measured: Day 180 after hospital discharge
Maximal inspiratory pressure (PImax)
Change from baseline
Measured: Day 90 and 180 after hospital discharge
Baseline/Transition Dyspnea Index (BDI/TDI)
Change from baseline
Measured: Day 28, 90, 180 after hospital discharge
EQ-5D-5L questionnaire
Change from baseline
Measured: Day 28, 90, 180 after hospital discharge
COPD Assessment test (CAT)
Change from baseline
Measured: Day 28, 90, 180 after hospital discharge
Adverse events
- Occurrence
- Number of occurrences/patient post-discharge
Measured: Day 90, 180 after hospital discharge
Serious adverse events
- Occurrence
- Number of occurrences/patient post-discharge
Measured: Day 90 and 180 after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start6 Jan 2026
- Primary completionJun 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseasesStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Daniel Langer, KU Leuven
- Investigators
- Daniel Langer, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213128
- Sponsor's protocol ID
- S68174
- Other IDs
- INV23-1479, S68174
- Acronym
- IN-SPIRED
- Status last verified
- Jan 2026
- First submitted
- 15 Sep 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there are no plans to share individual participant data (IPD). De-identified participant-level data will not be made publicly available. However, summary results of the trial will be published in peer-reviewed journals and presented at scientific meetings. Researchers interested in secondary analyses may contact the sponsor (UZ Leuven) to discuss possibilities for collaborative projects, subject to approval by the Trial Steering Committee and compliance with applicable regulations and GDPR.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07213128
- Acronym / sponsor ID
- IN-SPIRED / S68174
- Keywords
- Inspiratory muscle training, Respiratory muscle training, acute exacerbation, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- 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 start
- 6 Jan 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Training |
| Control | No intervention | –Patients will receive usual care, including optimal pharmacological therapy per international guidelines, advise on smoking cessation, vaccination, and physical activity participation and advised to attend physiotherapy or a respiratory rehabilitation program based on accessibility and patient preference. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traininghome-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. | Other | Intervention |
Primary outcome
Composite outcome (all-cause hospital readmission or mortality)
Time frame: within 180 days after hospital discharge
23 secondary outcomes
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
Change in Functional Residual Capacity (FRC), %predicted
Time frame: Day 180 after hospital discharge
Change in Residual Volume (RV), liters
Time frame: Day 180 after hospital discharge
Change in Residual Volume (RV), % predicted
Time frame: Day 180 after hospital discharge
Change in Total Lung Capacity (TLC), liters
Time frame: Day 180 after hospital discharge
Change in Total Lung Capacity (TLC), %predicted
Time frame: Day 180 after hospital discharge
Maximal inspiratory pressure (PImax)
Time frame: Day 90 and 180 after hospital discharge
Baseline/Transition Dyspnea Index (BDI/TDI)
Time frame: Day 28, 90, 180 after hospital discharge
EQ-5D-5L questionnaire
Time frame: Day 28, 90, 180 after hospital discharge
COPD Assessment test (CAT)
Time frame: Day 28, 90, 180 after hospital discharge
Adverse events
Time frame: Day 90, 180 after hospital discharge
Serious adverse events
Time frame: Day 90 and 180 after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No. At this time, there are no plans to share individual participant data (IPD). De-identified participant-level data will not be made publicly available. However, summary results of the trial will be published in peer-reviewed journals and presented at scientific meetings. Researchers interested in secondary analyses may contact the sponsor (UZ Leuven) to discuss possibilities for collaborative projects, subject to approval by the Trial Steering Committee and compliance with applicable regulations and GDPR.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Langer, PhD principal investigator
KU Leuven
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Chronic Obstructive Pulmonary Diseases and COPD, run by KU Leuven at 12 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marine Van Hollebeke, PhD (0032498606820, marine.vanhollebeke@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome (all-cause hospital readmission or mortality) (time frame: within 180 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.