Clinical Trial: Effects of the BONE Program on Bone Health, Peripheral Circulation, and Glycation-Related Indices in Older Women: A Randomized Wait-list Controlled Trial (Japan)

Tokyo, Sept. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062983) titled 'Effects of the BONE Program on Bone Health, Peripheral Circulation, and Glycation in Older Women' on Sept. 18.

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 - Bone health in older women (not limited to a specific disease) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to investigate the effects of a once-weekly, 2-month BONE exercise program on bone health, peripheral circulation, and glycation-related indices in community-dwelling older women. All participants will initially undergo a 2-month control period and will then be randomly assigned to two groups with different intervention start times using a wait-list controlled design. The effect of the BONE program will be evaluated by comparing the early-start group with the delayed-start group during the same study period. All participants will ultimately receive the BONE intervention, allowing additional within-participant comparisons between control and intervention periods. Bone health will be assessed using lumbar spine bone mineral density measured by REMS and ultrasound-based bone parameters of the radius. Peripheral circulation will be assessed using estimated hemoglobin levels, vessel width, VOI, and finger surface temperature measured by ASTRIM FIT. Glycation-related indices will be assessed using the AGE Scanner. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will continue their usual daily activities without the BONE program during the initial 2-month control period. Following randomization at month 2, participants will receive the BONE exercise program once weekly for 2 months, from month 2 to month 4. They will subsequently undergo a 2-month post-intervention follow-up period from month 4 to month 6. Assessments will be performed at baseline and at months 2, 4, and 6. Interventions/Control_2 - Participants will continue their usual daily activities without the BONE program during the initial 4-month wait-list control period. Following randomization at month 2, participants will remain on the wait-list for an additional 2 months and will then receive the BONE exercise program once weekly for 2 months, from month 4 to month 6. Assessments will be performed at baseline and at months 2, 4, and 6.

Eligibility: Age-lower limit - 60 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - 1. Community-dwelling women aged 60 years or older. 2. Individuals who have received sufficient information about the study and provided written informed consent. 3. Individuals who are able to safely participate in the BONE exercise program. 4. Individuals who are able to continuously participate in the once-weekly, 2-month BONE exercise program. 5. Individuals who are able to complete the scheduled assessments during the study period. 6. Individuals who are not regularly participating in the BONE program at the start of the study. Key exclusion criteria - 1. Individuals who have been advised by a physician to restrict physical exercise. 2. Individuals with severe cardiovascular, musculoskeletal, neurological, or other conditions that may prevent safe participation in the exercise program. 3. Individuals who are unable to continuously participate in the exercise program or complete the required assessments during the study period. 4. Individuals who are regularly participating in the BONE program at the start of the study. 5. Individuals who are considered unsuitable for participation by the principal investigator. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 18 Day Date of IRB - 2026 Year 05 Month 12 Day Anticipated trial start date - 2026 Year 09 Month 19 Day Last follow-up date - 2027 Year 03 Month 19 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072108

Disclaimer: Curated by HT Syndication.