Interstitial lung disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients diagnosed with interstitial lung disease Patients aged 18 years or older Patients judged by a physician to be able to participate in the study Patients with stable interstitial lung disease
Exclusion criteria
Exclusion criteria: Patients immediately after acute exacerbation of interstitial lung disease Patients with marked hypoxemia Patients in whom pulse oximeter measurement is considered unreliable Patients with orthopedic disease or peripheral neuropathy that prevents performance of the 6-minute walk test, 1-minute sit-to-stand test, or 6-minute step test Patients in whom bioelectrical impedance body composition assessment may be affected by implanted metal devices, pacemakers, or similar conditions Patients who do not provide informed consent or who withdraw consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Concurrent validity based on the correlations among the 6-minute walk distance in the 6-minute walk test, the number of repetitions in the 1-minute sit-to-stand test, and the number of steps in the 6-minute step test 2. Validity of the 1-minute sit-to-stand test and the 6-minute step test for detecting exercise-induced desaturation compared with the 6-minute walk test 3. Agreement in exercise limitation factors related to respiratory, circulatory, and skeletal muscle function, namely whether the 1-minute sit-to-stand test and the 6-minute step test can detect exercise limitation factors to a similar extent as the 6-minute walk test | — |
Secondary
| Measure | Time frame |
|---|---|
| As exploratory outcomes, the following variables will be collected or assessed: Patient characteristics: age, sex, height, body weight, body mass index, GAP Index, smoking history, diagnosis, disease history, and medication history. Blood tests: PaO2, PaCO2, white blood cell count, C-reactive protein, KL-6, and SP-D. Pulmonary function: VC, %VC, FVC, %FVC, FEV1.0, %FEV1.0, DLco, %DLco, MIP, and MEP. Dyspnea: modified Medical Research Council dyspnea scale. Physical function: Short Physical Performance Battery. Skeletal muscle assessment: grip strength, isometric knee extension strength, skeletal muscle mass, muscle mass, and skeletal muscle index. Exercise tests: In the 6-minute walk test, 6-minute walk distance, modified Borg Scale scores for dyspnea and lower-limb fatigue, blood pressure, SpO2, respiratory rate, heart rate, tissue oxygen saturation (tissue saturation index: TSI, tissue oxygen saturation: StO2), oxyhemoglobin, deoxyhemoglobin, and total hemoglobin will be assessed. In the 1-minute sit-to-stand test, the number of repetitions, modified Borg Scale scores for dyspnea and lower-limb fatigue, blood pressure, SpO2, respiratory rate, heart rate, tissue oxygen saturation (TSI, StO2), oxyhemoglobin, deoxyhemoglobin, and total hemoglobin will be assessed. In the 6-minute step test, the number of steps, modified Borg Scale scores for dyspnea and lower-limb fatigue, blood pressure, SpO2, respiratory rate, heart rate, tissue oxygen saturation (TSI, StO2), oxyhemoglobin, deoxyhemoglobin, and total hemoglobin will be assessed. | — |
Countries
Japan
Contacts
Seirei Christopher University Faculty of Rehabilitation