Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Airofit IMT device: The Airofit is a new IMT device, which combines a calibrated inspiratory flow resistance with a pressure transducer and mobile device app. As the user inhales throug
the magnitude of the load is proportional to the rate of air flow, as well as to the flow resistance properties of the load setting. The former has been identified as a limitation of flow-resistive IM
Sponsors
Airofit AS Copenhagen Denmark
Padmashree Dr D Y Patil Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 1. All the subjects with spirometry-proven, stable COPD (GOLD stage II and above) will be screened for inclusion. 2.Patients with maximal inspiratory pressure (MIP) less than 100% of predicted will be included 3.Patients with the age between 35 to 65 years will be included in the study
Exclusion criteria
Exclusion criteria: 1. Subjects without access to a suitable smartphone or tablet for the duration of intervention 2. Subjects with an inability to read and understand written and verbal instructions in English 3. Subjects with a history of hospitalization during the previous 4 weeks 4. Subjects with severe orthopedic problems during the previous 4 weeks 5. Subjects with a diagnosed psychiatric or cognitive disorders 6. Subjects with a progressive neurological or neuromuscular disorder 7. Subjects on the waiting list of lung transplantation 8. Subjects with previous inclusion in a rehabilitation program 9. Subjects with previous experience of IMT 10. Patients with underlying bronchiectasis, ILC, post-covid, and post tuberculosis sequelae 11. All the COPD patients with active Covid status or within 15 days of post-covid recovery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the ability of Airofit device to provide improvement in the inspiratory muscle strength, assessed using a change in MIP after 12 weeks of home-based IMT intervention in COPD patients.Timepoint: To evaluate the ability of Airofit device to provide improvement in the inspiratory muscle strength, assessed using a change in MIP after 12 weeks of home-based IMT intervention in COPD patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the ability of the COPD patients to use the Airofit device and a mobile app interface for routine, home-based use as a medical device to improve inspiratory muscle strengthTimepoint: After 4 and 12 weeks of intervention;To evaluate the occurrence of any adverse event (AE) throughout the study period.Timepoint: At the baseline and after intervention of 4 and 12 weeks;To explore the change in MIP after loading the inspiratory muscles using home-based IMT with the Airofit device in comparison to an existing medical device â??POWERbreatheâ??, and a control device â??Breathing pacerâ?? in COPD patients.Timepoint: After 4 and 12 weeks of intervention | — |
Countries
India
Contacts
Public ContactDr Atul Deshmukh
Padmashree Dr. D Y Patil University Navi Mumbai
Outcome results
None listed