Tokyo, June 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061919) titled 'Comparison of exercise limitation factors detected by three field tests including assessment of skeletal muscle function in patients with interstitial lung disease: a comparison of the 6-minute walk test, 1-minute sit-to-stand test, and 6-minute step test' on June 16.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Seirei Christopher University
Condition:
Condition - Interstitial lung disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to perform the 6-minute walk test, 1-minute sit-to-stand test, and 6-minute step test in the same patients with interstitial lung disease and to clarify the following three points. First, the concurrent validity of the 1-minute sit-to-stand test and the 6-minute step test against the 6-minute walk test will be examined based on the correlations among 6-minute walk distance, the number of repetitions in the 1-minute sit-to-stand test, and the number of steps in the 6-minute step test. Second, the 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 will be examined. Third, the agreement in exercise limitation factors related to respiratory, circulatory, and skeletal muscle function will be evaluated to determine 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.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Participants will undergo the 6-minute walk test, 1-minute sit-to-stand test, and 6-minute step test. During each test, SpO2 and heart rate will be measured using a pulse oximeter, tissue saturation index (tissue oxygen saturation) of the right vastus lateralis will be assessed using near-infrared spectroscopy, and video recording will be performed to evaluate respiratory rate. Adequate rest will be provided between tests, and the procedures will be performed with priority given to safety while monitoring general condition, respiratory status, SpO2, subjective symptoms, and fatigue. For each participant, measurements will be performed over approximately 1 to 2 days for inpatients and over 2 to 3 days within approximately 1 month for outpatients. The participant's physical condition and clinical schedule will be prioritized, and the assessments may be divided into separate sessions as needed.
Eligibility:
Age-lower limit - 18
years-old
<
Age-upper limit - Not applicable
Gender - Male and Female
Key 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
Key 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
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 05 Day
Date of IRB - 2026 Year 06 Month 05 Day
Anticipated trial start date - 2026 Year 06 Month 16 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070848
Disclaimer: Curated by HT Syndication.
