Effect of IMT in Patients After Acute Exacerbations of COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-06

Study Completion Date

2029-02-28

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Diseases COPD Symptom Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Training

Intervention Type 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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Daniel Langer

associate professor Faculty of Movement and Rehabilitation Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Langer, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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AZORG

Aalst, , Belgium

Site Status RECRUITING