Tokyo, July 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062120) titled 'Prospective Observational Study of Changes in Physical Function, Autonomic Nervous Function, and Quality of Life Associated with Wearing the Relive Innerwear (Top and Leggings Set)' on July 3.

Study Type: Observational

Primary Sponsor: Institute - Hiroshima University

Condition: Condition - nothing Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this prospective observational study is to evaluate longitudinal changes in physical function, autonomic nervous system function, peripheral circulation, sleep, mood status, subjective health status, and health-related quality of life (QOL) in adults aged 60 years or older who routinely wear the Relive Inner Shirt and Leggings Set. The study will also exploratorily assess wearing adherence, safety, and feasibility to obtain preliminary data regarding the potential of this non-pharmacological approach for supporting health maintenance and quality of life in older adults. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 60 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Male or female participants aged 60 years or older. 2.Participants who subjectively experience fatigue, easy fatigability, or decreased muscle strength in daily life. 3.Participants who are able and willing to wear the Relive Inner Shirt and Leggings Set continuously during the study period in their daily lives. Key exclusion criteria - 1.Participants with severe cardiovascular, respiratory, neurological, psychiatric, or malignant diseases, or any other serious underlying medical condition, who are considered unsuitable for participation by the principal investigator or sub-investigator. 2.Participants with skin diseases, rash, pruritus, contact dermatitis, allergy to clothing materials, or other conditions that may worsen with wearing the Relive Inner Shirt and Leggings Set. 3.Participants with cognitive impairment, communication difficulties, or visual or hearing impairment that would interfere with understanding the study, providing informed consent, completing questionnaires, or undergoing study assessments. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 14 Day Anticipated trial start date - 2026 Year 08 Month 15 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=R000071083

Disclaimer: Curated by HT Syndication.