Clinical Trial: An interventional study examining the effects and correlations of exercise and health support programs including the BONE program on physical function, immune function, cognitive function, posture, quality of life, and comprehensive health indicators in middle-aged and older adult women (Japan)

Tokyo, April 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061376) titled 'Effects and associations of exercise and health support programs including the BONE program on physical function, immune function, cognitive function, posture, and comprehensive health-related indicators in middle-aged and older adult women' on April 26.

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 - Middle-aged and older adult women with concerns regarding aging, physical inactivity, decreased physical activity, reduced bone density, decreased immune function, reduced physical function, cognitive decline, impaired posture-related function, and decreased health-related indicators Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to examine multidimensional changes in and correlations among bone density, immune function, muscle strength, gait function, cognitive function, posture, quality of life, lifestyle, psychological and behavioral indicators, and subjective health status through the implementation of exercise and health support programs including the BONE program for middle-aged and older adult women, and to exploratorily clarify the effectiveness, safety, feasibility, and applicability of the programs. The programs may be delivered face-to-face, online, on demand, at home, in facilities, or through a combination of these methods. This study may also include other related experiments, measurements, questionnaires, physical function assessments, cognitive function assessments, posture assessments, psychological and behavioral assessments, and feasibility assessments beyond those listed above. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants who provide informed consent will be randomly allocated to the intervention group or the control group. Participants in the intervention group will perform exercise and health support programs including the BONE program for a specified period. The programs may include components designed to maintain or improve bone and muscle function, gait function, postural control, physical activity, cognitive function, quality of life, and comprehensive health-related indicators. The delivery method is not limited to on-demand distribution; the programs may be delivered face-to-face, online, on demand, at home, in facilities, or through a combination of these methods. The frequency, duration, and intervention period will be determined according to the study protocol, participant conditions, safety considerations, and feasibility. Interventions/Control_2 - Participants in the control group will not perform the exercise or health support programs including the BONE program specified in the study during the same period and will continue their usual lifestyle or usual activities. Similar to the intervention group, health checks, physical function assessments, immune function assessments, cognitive function assessments, posture assessments, quality-of-life questionnaires, lifestyle surveys, subjective assessments, and related evaluations may be conducted before and after the study period.

Eligibility: Age-lower limit - 18 years-old = Gender - Female Key inclusion criteria - Adult women, including middle-aged and older adults Individuals who receive an explanation of the study and provide informed consent to participate Individuals who are able to participate in exercise and health support programs including the BONE program, health checks, physical function assessments, immune function assessments, cognitive function assessments, posture assessments, quality-of-life surveys, lifestyle surveys, subjective assessments, and related evaluations Individuals who are able to participate in interventions or assessments delivered face-to-face, online, on demand, at home, in facilities, or through a combination of these methods Individuals who are able to participate in the study while continuing their usual lifestyle or usual activities Key exclusion criteria - Individuals who have been prohibited from exercising by a physician or other healthcare professional Individuals who are judged to have difficulty completing the intervention or assessments Individuals with serious disease, acute symptoms, or orthopedic, neurological, or cardiovascular problems that may interfere with exercise participation Individuals who do not 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 26 Day Last follow-up date - 2026 Year 06 Month 26 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070229

Disclaimer: Curated by HT Syndication.