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The usefulness of the 1-minute sit-to-stand test in patients with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis in an open-label, randomized, crossover, controlled trial.

The usefulness of the 1-minute sit-to-stand test

Yoshito Miyata

Showa University School of Medicine

1-5-8 Hatanodai, Shinagawa-ku

ym820127@med.showa-u.ac.jp

Yoshito Miyata

Showa University School of Medicine

1-5-8 Hatanodai, Shinagawa-ku

+81-337848000

ym820127@med.showa-u.ac.jp

Recruiting

April. 17, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

crossover assignment

diagnostic purpose

1) Patients diagnosed with IPF or PPF attending the outpatient department of respiratory allergy at Showa University Hospital
2) Patients who are 20 years of age or older at the time of consent (regardless of gender)
3) Patients who have given written consent to participate in this study

1) Patients who developed unstable angina pectoris or myocardial infarction within 1 month
2) Patients diagnosed with stable angina pectoris
3) Patients with a resting heart rate of 120/min or higher or a resting blood pressure of 180/100 mm Hg or higher
4) Patients with gait disturbance because of complications of neurological disease, orthopedic disease, or peripheral arterial disease
5) Patients who developed a respiratory infection within one month
6) Patients receiving home oxygen therapy
7) Patients expected to have difficulty continuing with the 6-minute walk test or 1-minute sit-to-stand test
8) Patients deemed ineligible at the discretion of the investigator.

Both

Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

On the same day, Group A (6-minute walk test to 1-minute sit-to-stand test) and Group B (1-minute sit-to-stand test to 6-minute walk test) will be determined and administered with a 30-minute break between tests.

idiopathic pulmonary fibrosis, progressive pulmonary fibrosis

Difference in minimum transcutaneous arterial blood oxygen saturation during exertion at 6MWT and 1STST

Comparison of the percentage of patients with SpO2 less than 90% during the study in 6MWT and 1STST
Comparison of the percentage of patients with a difference of over 4% in SpO2 at rest and during exertion at 6MWT and 1STST
Comparison of SpO2 at rest in 6MWT and 1STST
Heart rate at rest in 6MWT and 1STST
Maximal heart rate during exertion at 6MWT and 1STST
Comparison of post-test Borg scale in 6MWT and 1STST
Comparison of clinical characteristics of patients with and without a difference of MCID (1 point) on the post-test Borg scale at 6MWT and 1STST
Comparison of clinical characteristics of patients with a minimum SpO2 value of less than 90% and over 90% during exertion at 6MWT and 1STST
Comparison of clinical characteristics of patients with a difference in SpO2 between resting and exertion of over 4% and less than 4% at 6MWT and 1STST

+81-3-3784-8129

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