Tokyo, July 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062295) titled 'Elucidating temporal changes in percutaneous arterial oxygen saturation and gait during dyspnea, and exploring fall risk' on July 21.

Study Type: Observational

Primary Sponsor: Institute - Reiwa Health Sciences University

Condition: Condition - Chronic respiratory disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To simultaneously measure SpO2 time-series and gait metric time-series during the 6-Minute Walk Test (6MWT), quantify the effect of SpO2 decline on gait changes, and identify the SpO2 threshold that predicts gait deterioration. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - Disease: Stable chronic respiratory disease (primarily COPD and interstitial lung disease) / Age: 40 years or older / Pulmonary function: Obstructive or restrictive ventilatory impairment confirmed by spirometry / Ambulatory status: Able to walk independently (with or without a walking aid) / Physical condition: Able to perform the 6MWT / Capacity to consent: Able to provide written informed consent Key exclusion criteria - 1. Acute exacerbation: History of acute exacerbation (e.g., airway infection, worsening dyspnea) or hospitalization within 1 month before enrollment. 2. Long-term oxygen therapy (LTOT): Patients for whom adequate oxygenation during the 6MWT cannot be maintained without changing the usual conditions (flow rate, device). 3. Neurological, muscular, or musculoskeletal disease: Any condition affecting gait (e.g., Parkinson's disease, post-stroke sequelae, peripheral neuropathy, osteoarthritis, post-fracture sequelae). 4. Cognitive function: Unable to provide consent due to cognitive impairment. 5. Physician's judgment: Deemed ineligible for participation by the attending physician for other reasons. Target Size - 40

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 07 Month 21 Day Date of IRB - 2026 Year 07 Month 16 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071290

Disclaimer: Curated by HT Syndication.