Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | IN-SPIRED: a randomised, multicentre, parallel group clinical trial to investigate 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 |
| Participants (P) | Patients aged 35 and above with chronic obstructive pulmonary disease (COPD) hospitalised due to an acute exacerbation, without other significant pulmonary disease or acute cardiac instability. |
| Intervention (I) | Home inspiratory muscle training (IMT), with 2 sessions daily during the intensive phase (days 0 to 90) and once daily during the maintenance phase (days 91 to 180), in addition to usual care. IMT will be performed using a device (either Airofit PRO 2.0 or POWERBreathe Medic Plus) and supported with a smartphone app. IMT will also be supervised in 9 telemonitoring sessions. |
| Control (C) | Usual care includes: • optimal pharmacological therapy per international guidelines including long-acting bronchodilators, inhaled corticosteroids and long-term macrolides at the discretion of the treating physician • advice on smoking cessation • vaccination • physical activity participation for example advised to attend community physiotherapy or a hospital ambulatory respiratory rehabilitation program based on accessibility and patient preference |
| Outcome (O) | A composite endpoint defined as all-cause hospital readmission or death within 180 days after hospital discharge |
| Trial Design | Randomized, multicentre, parallel-group clinical superiority trial |
| Sample Size | 358 participants |
| Trial duration | 42 months from FPI to CSR |
| Budget | 1,650,000 € |
Trial team
| Sponsor | UZ Leuven |
| Chief Investigator | Prof. Dr. PT. Daniel Langer |
| External partners | not applicable |
| Number of participating sites | 12 sites in Belgium (3 Wallonia, 2 Brussels and 7 Flanders) |
DOCUMENTS
References
Clinicaltrials.gov: NCT07213128
Webpage: https://www.inspiredtrial.be/en
Funding scheme
