Tokyo, April 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061379) titled 'Effects and associations of exercise and health support programs on physical function, immune function, cognitive function, posture, blood flow, quality of life, and comprehensive health-related indicators in adult men' on April 30.

Study Type: Interventional

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

Primary Sponsor: Institute - Hiroshima University

Condition: Condition - Adult men who are eligible for assessment of health-related indicators, including health status, physical function, bone density, immune function, cognitive function, posture, blood flow or circulatory function, quality of life, lifestyle, and psychological and behavioral indicators Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to examine multidimensional changes in and associations among health-related indicators, including bone density, physical function, muscle strength, gait function, cognitive function, posture, quality of life, lifestyle, psychological and behavioral indicators, and blood flow or circulatory function, through exercise and health support programs including the BONE program and related assessments for adult men. The study also aims to exploratorily clarify the effectiveness, safety, feasibility, and applicability of the programs or assessment methods. The target population includes a broad range of adult men, from healthy young adults to middle-aged and older adults. The delivery format is not limited to on-demand delivery and may include face-to-face, remote, home-based, facility-based, or combined formats. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants in the intervention group will participate in exercise and health support programs, including the BONE program, after providing informed consent and according to the study protocol. The programs may include exercise and health support components aimed at improving trunk function, lower-limb function, posture, flexibility, muscle strength, balance, and physical activity. The delivery format is not limited to on-demand delivery and may include face-to-face, remote, home-based, facility-based, or combined formats. The frequency, duration, session length, and delivery method will be determined according to the study protocol. Assessments of physical function, bone density, cognitive function, posture, blood flow or circulatory function, quality of life, lifestyle, and subjective health status may be conducted before and after the intervention or between assessment time points. Interventions/Control_2 - Participants in the control group will continue their usual lifestyle or usual activities during the study period. Similar to the intervention group, assessments of physical function, bone density, cognitive function, posture, blood flow or circulatory function, quality of life, lifestyle, and subjective health status may be conducted before and after the observation period or between assessment time points according to the study protocol.

Eligibility: Age-lower limit - 18 years-old = Gender - Male Key inclusion criteria - Eligible participants are individuals who meet the following criteria: Adult men. Individuals ranging from healthy young adult men to middle-aged and older adult men who are able to participate in the assessments or interventions specified in the study protocol. Individuals who provide informed consent to participate in the study. Individuals who are able to participate in exercise and health support programs including the BONE program, physical function assessments, bone density measurements, cognitive function assessments, posture assessments, blood flow or circulatory function assessments, quality-of-life assessments, lifestyle surveys, and subjective assessments. Individuals who are able to participate in assessments or interventions delivered at facilities, at home, face-to-face, remotely, on demand, or through combined methods specified in the study protocol. Key exclusion criteria - Individuals who meet any of the following criteria will be excluded: Individuals who are judged to have difficulty participating in the intervention or assessments. Individuals who have been restricted from exercising by a physician or other healthcare professional. Individuals with serious disease, pain, injury, neuromuscular disorders, cardiovascular disease, or other medical conditions that may interfere with participation. Individuals who cannot provide informed consent to participate in the study. Individuals who are judged by the principal investigator or co-investigators to be inappropriate for participation in this study. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 01 Day Anticipated trial start date - 2026 Year 04 Month 30 Day Last follow-up date - 2026 Year 07 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070230

Disclaimer: Curated by HT Syndication.