Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058488) titled 'Portable Cardiopulmonary Assessment in ILD: Prospective Interventional Study Comparing Three Exercise Testing Modalities' on July 16.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kanagawa Cardiovascular and Respiratory Center
Condition:
Condition - Interstitial Lung Disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Three types of exercise tests will be performed and evaluated with a portable respiratory gas exchange analyzer for comparison. Exercise tolerance and cardiopulmonary responses will be evaluated and their relationship to severity will be investigated.
Basic objectives2 - Bio-equivalence
Intervention:
Interventions/Control_1 - Participants will wear a portable respiratory gas exchange analyzer and perform three types of exercise tests.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients will be deemed eligible for the study if they are diagnosed with interstitial lung disease, clinically stable, and have no pulmonary rehabilitation session for the passed 6 months.
Key exclusion criteria - People with CRD will be excluded if they (i) have the potential to cause significant hypoxemia with exercise; (ii) require nasal cannula oxygenation (including home oxygen therapy) ; (iii) have complications or disabilities that make exercise difficult; (iv) have cardiac disease that puts participants at risk for exercise; (v) forbidden by their doctors to exercise; (vi) have inadequate understanding of exercise stress testing; (vii) are diagnosed with dementia; (viii) have visual or hearing problems in performing exercise training
Target Size - 60
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2021 Year 02 Month 21 Day
Date of IRB - 2021 Year 04 Month 05 Day
Anticipated trial start date - 2021 Year 04 Month 15 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066855
Disclaimer: Curated by HT Syndication.