Clinical Trial: Effects of a Pottery Program in Community Pharmacy on the Physical and Psychosocial Health of Older Adults (Japan)

Tokyo, Sept. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059019) titled 'Effects of a Pottery Program in Community Pharmacy on the Physical and Psychosocial Health of Older Adults' on Sept. 6.

Study Type: Interventional

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

Primary Sponsor: Institute - Konan Pharmacy

Condition: Condition - Not applicable (community-dwelling older adults aged 75 years or older with independent ADL) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of a community-pharmacy-based "Pottery + Health Monitoring Program (Senior Plan)" on social connectedness (LSNS-6 as the primary focus) and on physical, cognitive, sleep, and depressive symptoms through a 12-24-month longitudinal intervention. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Pottery + Health Monitoring Program (Senior Plan): Once per week, 60-90 minutes per session, for 12-24 months. At each session, measure body weight, blood pressure, pulse rate, SpO2, and grip strength, with brief health guidance as needed. Primary assessment at 12 months. Assessments at baseline, 3, 6, 12, 18, and 24 months.

Eligibility: Age-lower limit - 75 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Community-dwelling older adults aged 75 years or older Independent in ADL Able to understand the study and provide written informed consent Able to attend pottery sessions throughout the study period LSNS-6 can be assessed at baseline Key exclusion criteria - Medical conditions that preclude safe participation (e.g., severe or unstable cardiopulmonary disease) Severe upper-limb functional impairment or severe visual/hearing impairment that prevents safe pottery work or outcome assessments Cognitive impairment that precludes consent or adherence Considered inappropriate by the investigator Residents of institutional care facilities (not community-dwelling) Target Size - 16

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 06 Month 02 Day Date of IRB - 2025 Year 07 Month 11 Day Anticipated trial start date - 2025 Year 08 Month 01 Day Last follow-up date - 2027 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067495

Disclaimer: Curated by HT Syndication.