Tokyo, Nov. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059708) titled 'Safety and Efficacy of Home-Based Respiratory Muscle Stretching Exercises Using Information and Communication Technology in Patients with Chronic Obstructive Pulmonary Disease' on Nov. 10.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Juntendo University

Condition: Condition - Chronic Obstructive Pulmonary Disease Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to compare the implementation of ICT-supported home-based respiratory muscle stretching exercises for COPD patients before and after the intervention, evaluating its effectiveness (changes in CAT scores), safety (adverse events, readmissions, falls), and implementation rate. Furthermore, it will examine the feasibility and continuity of an ICT-supported program for patients who find outpatient rehabilitation difficult. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants performed respiratory muscle stretching exercises at home twice daily for 8 weeks using an instructional video. A smartwatch and tablet application were used to monitor step count, heart rate, and exercise adherence. Feedback and reminders were provided via chatbot. A follow-up outpatient visit was held at week 4, and reassessment was conducted at week 8.

Eligibility: Age-lower limit - 50 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Outpatient follow-up visits to the above medical departments 2.Aged 50 or older at the time of consent acquisition 3.Ability to walk independently (including with a cane) 4.Condition is stable with standard treatment. 5.Individuals with a COPD Assessment Test score of 10 or higher, or an mMRC grade of 2 or higher. 6.No history of COPD exacerbation within the past 3 months 7.Individuals who, after receiving sufficient explanation regarding participation in this study, provided written consent of their own free will based on full understanding 8.Individuals living with family members Key exclusion criteria - 1.Patients unable to walk independently or unable to undergo medical interviews or questionnaire administration 2.Patients with pacemakers (as the safety of digital devices like Fitbit cannot be guaranteed) 3.Patients with severe cerebrovascular disease, heart disease, respiratory disease, liver disease, kidney disease, digestive disease, or endocrine/metabolic disease 4.Patients with a life expectancy of less than one year due to malignant diseases, etc. 5.Patients with severe physical disabilities requiring long-term rehabilitation 6.Other individuals deemed unsuitable as research subjects by the principal investigator 7.Among the research subjects described in (1) above, eligibility is determined by satisfying all selection criteria in (2) and not meeting any exclusion criteria in (3). Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 10 Day Date of IRB - 2025 Year 10 Month 07 Day Anticipated trial start date - 2025 Year 11 Month 10 Day Last follow-up date - 2026 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068294

Disclaimer: Curated by HT Syndication.