Effect of IMT in Patients After Acute Exacerbations of COPD (IN-SPIRED)

Catholic University (KU) of Leuven

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Diseases; Symptom Exacerbation; COPD

Treatments: Other: Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07213128

INV23-1479 (Other Identifier)

S68174 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 358 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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358 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Other: Training

Control

No Intervention group

Description:

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.