Idiopathic pulmonary fibrosis Idiopathic interstitial pneumonia
Conditions
Interventions
Patients in the inspiratory muscle training group are given the Power-Breeze Medic Plus on the first day of training and are asked to perform inspiratory muscle training. Patients in the control group
Respiratory muscle training
Sponsors
Ohkubo Hirotsugu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who have been diagnosed with idiopathic pulmonary fibrosis according to international guidelines (2) Patients currently receiving treatment at Nagoya City University Hospital, Nagoya City University Midori Municipal Hospital, Nagoya City University Medical School Eastern Medical Center, Fujita Health University Hospital, Kyoto University Hospital, Tokyo Medical University Hospital, and Shiga University of Medical Science Hospital (3) 40 years of age or older and 85 years of age or younger (4) Patients with an mMRC score of grade 1 to grade 3 for shortness of breath (5) Patients who understand the necessity of participating in this study and who provide written informed consent
Exclusion criteria
Exclusion criteria: (1) Patients who have experienced acute exacerbation of idiopathic pulmonary fibrosis or pneumonia within 3 months prior to enrollment (2) Patients with a history of pneumothorax or pneumomediastinum (3) Asthma patients with frequent exacerbations (4) Patients with ear damage such as tympanic membrane rupture (5) Patients with abdominal hernia (6) Patients with pulmonary hypertension (predicted pulmonary artery pressure of 45 mmHg or more by echocardiography) (7) Patients with large cysts on chest X-ray (8) Patients with a history of osteoporosis and fractures (9) Patients who have undergone abdominal surgery within 2 months prior to enrollment (10) Patients receiving oxygen therapy at rest (11) Patients who have difficulty in walking tests due to wheelchair use, etc. (12) Patients with malignant tumors whose progression is deemed uncontrollable (13) Patients with aortic aneurysms (14) Other patients who the principal investigator/subinvestigator deems inappropriate as study subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in health-related QOL (Activity score of the SGRQ questionnaire) after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Changes in health-related QOL (Activity score of the SGRQ questionnaire) from the start of treatment at 24, 40, and 56 weeks b) Changes in resting SpO2 and pulse rate from the start of treatment at 8, 24, 40, and 56 weeks c) Changes in health-related QOL (Total score, Symptom score, and Impact score of the SGRQ questionnaire) from the start of treatment at 8, 24, 40, and 56 weeks d) Changes in maximum inspiratory oral pressure (PImax) measured by the IOP-01 respiratory muscle dynamometer from the start of treatment at 8, 24, 40, and 56 weeks e) Changes in shortness of breath assessment (mMRC score) from the start of treatment at 8, 24, 40, and 56 weeks f) Changes in shortness of breath (dyspnea 12 questionnaire) from the start of treatment at 8, 24, 40, and 56 weeks g) Changes in depression and anxiety questionnaire scores (HADS) from the start of treatment at 8, 24, 40, and 56 weeks h) Changes in forced vital capacity from the start of treatment at 8, 24, 40, and 56 weeks i) Changes in pulmonary diffusion capacity from the start of treatment at 8 and 56 weeks j) Changes in walking distance and minimum SpO2 in the 6-minute walk test from the start of treatment at 8 and 56 weeks k) Comparison of the incidence of adverse events between the inspiratory muscle training group and the control group up to 8 weeks, 24 weeks, 40 weeks, and 56 weeks after the start of inspiratory muscle training Comparison of the frequency of occurrence of adverse events | — |
Contacts
Public ContactHirotsugu Ohkubo
Nagoya City University Hospital
Outcome results
None listed