Tokyo, Sept. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062806) titled 'A study to evaluate the effects and safety of respiratory muscle stretching exercise with smartwatch-based remote monitoring in patients with COPD (chronic obstructive pulmonary disease)' on Sept. 7.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Juntendo University

Condition: Condition - COPD Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy, safety, and adherence of a home-based respiratory muscle stretching exercise program combined with ICT-based remote monitoring in patients with COPD, through a multicenter randomized controlled trial. This study also aims to clarify the feasibility and continuity of an ICT-based home pulmonary rehabilitation program for patients who have difficulty accessing outpatient-based pulmonary rehabilitation. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intervention group: After a 1-week wearable-only run-in period (remote monitoring of step count and heart rate via smartwatch, without exercise), participants perform respiratory muscle stretching exercise at home twice daily for 8 weeks, based on a video program developed by the principal investigator. Throughout the exercise period, step count, heart rate, and exercise adherence continue to be remotely monitored via smartwatch, and chatbot-based feedback messages are delivered via a provided tablet application to promote continued exercise and walking activity. A mid-point outpatient visit is conducted 4 weeks after exercise initiation to confirm adherence and provide guidance. Interventions/Control_2 - Control group: Participants continue usual care, without the respiratory muscle stretching program or wearable-based remote monitoring. Assessments (pulmonary function tests, questionnaires, etc.) are performed at baseline and at 8 weeks.

Eligibility: Age-lower limit - 50 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Outpatients regularly attending the relevant department at a participating institution Aged 50 years or older at the time of consent Diagnosed with COPD according to the Japanese Guideline for the Diagnosis and Treatment of COPD, 2022 Able to walk independently (with or without a cane) Clinically stable on standard treatment No history of COPD exacerbation within 3 months before enrollment Provided written informed consent voluntarily after receiving a full explanation and understanding of the study Key exclusion criteria - Unable to walk independently, or unable to complete interviews/questionnaires Presence of a cardiac pacemaker (due to unconfirmed safety of the digital wearable device) Severe cerebrovascular, cardiac, respiratory, hepatic, renal, gastrointestinal, or endocrine/metabolic disease Life expectancy of less than 1 year due to malignancy or other conditions Severe physical disability requiring long-term rehabilitation Any other reason judged by the principal investigator to make the patient unsuitable for participation Target Size - 60

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 06 Month 01 Day Date of IRB - 2026 Year 08 Month 10 Day Anticipated trial start date - 2026 Year 09 Month 04 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=R000071897

Disclaimer: Curated by HT Syndication.