Tokyo, Aug. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058841) titled 'Randomized controlled trial of multifactorial intervention for the prevention of lung function decline in elderly people at risk of chronic obstructive pulmonary disease' on Aug. 19.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Kobe University

Condition: Condition - The risk of chronic obstructive pulmonary disease is higher for older people. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to verify the effectiveness of a comprehensive program (exercise, lifestyle, nutrition) centered on exercise, including respiratory muscle training, for older people at risk of chronic obstructive pulmonary disease in a randomized controlled trial. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Implement a multifactorial intervention program consisting of an exercise program and a group work program focused on lifestyle habits and nutrition. The exercise program will consist of group exercise classes covering 1) stretching, 2) strength training, 3) aerobic exercise, and 4) respiratory muscle training, held once a week for 90 minutes per session, totaling 52 sessions over one year (assuming 52 weeks). Interventions/Control_2 - Distribution of health education texts.

Eligibility: Age-lower limit - 60 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) At the time of registration, you must be a resident of Taisho Ward, Osaka City, and 60 years of age or older. 2) Smoking history (including passive smoking). Passive smoking refers to daily or occasional exposure to smoke from other smokers in the home or workplace. 3) No diagnosis of COPD. 4) Dementia assessment (DASC-21) score of less than 31 points. Key exclusion criteria - 1) No history of smoking, including passive smoking. 2) Severe functional impairment requiring prohibition or restriction of movement, eating, or drinking (including bone and joint diseases, renal failure, ischemic heart disease, or cardiopulmonary dysfunction). 3) Diagnosed with dementia. 4) Even if not meeting exclusion criterion 2), if the attending physician or primary care physician determines that the subject is unsuitable for the study while undergoing outpatient treatment. Target Size - 100

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 03 Month 28 Day Date of IRB - 2025 Year 03 Month 28 Day Anticipated trial start date - 2025 Year 04 Month 07 Day Last follow-up date - 2027 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067281

Disclaimer: Curated by HT Syndication.