Tokyo, April 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061377) titled 'Exploratory study on the effects of a foot bone-strengthening program on bone-related, foot function, and health-related indicators' 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 - Male and female athletes and healthy individuals with, or at risk of, reduced bone-related indicators, impaired foot function, reduced toe muscle strength, impaired posture and balance function, or other physical and health-related concerns Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to exploratorily examine the effects of the BONE program, a foot bone-strengthening program focusing on the skeletal structure of the foot, on bone-related indicators, toe muscle strength, foot function, plantar pressure distribution, posture and balance function, physical function, body composition, vascular indicators, lifestyle factors, psychological and behavioral indicators, and health-related indicators in male and female participants. This study will also examine interrelationships among bone-related indicators, toe muscle strength, foot function, plantar pressure distribution, physical function, body composition, vascular indicators, lifestyle factors, and subjective assessments, and will comprehensively evaluate the effectiveness, safety, feasibility, and applicability of the program. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants who provide informed consent will be randomly allocated to either the intervention group or the control group. Participants in the intervention group will undergo foot-related, bone-related, and physical function improvement programs, including the BONE program, in addition to their usual club activities, usual practice, usual warm-up, or usual activity. The programs aim to provide low-intensity mechanical stimulation to the foot and lower limbs, enhance foot arch function, utilize the lever function of the foot bones, improve mobility of the foot bones, improve toe muscle strength and foot function, enhance posture and balance function, and improve physical function and health-related indicators. The programs may include foot stimulation using a wooden ball or similar tool, toe exercises, foot and lower-limb exercises, weight-bearing exercises, balance exercises, stretching, education, self-monitoring, and feedback. The intervention will generally be performed several times per week for approximately 15 minutes per session over approximately 1 to 3 months. The frequency, duration per session, intervention period, and method may be adjusted according to the study protocol, considering participant affiliation, training environment, feasibility, and safety. Interventions/Control_2 - Participants who provide informed consent and are randomly allocated to the control group will continue their usual club activities, usual practice, usual warm-up, or usual support without the additional BONE program or foot-related, bone-related, and physical function improvement programs. The control group will undergo assessments during the same period as the intervention group, including bone-related indicators, toe muscle strength, foot function, plantar pressure distribution, posture and balance function, physical function, body composition, vascular indicators, health-related indicators, and questionnaire-based measures.

Eligibility: Age-lower limit - 8 years-old = Gender - Male and Female Key inclusion criteria - Elementary school to high school-aged individuals. Male or female participants. Individuals who are able to participate in sports activities, physical activities, or assessments of health and physical function. Individuals who are able to participate in the BONE program, foot bone-strengthening program, usual activity, measurements, surveys, or assessments. Individuals who are able to undergo assessments of bone-related indicators, foot function, toe muscle strength, plantar pressure distribution, posture and balance function, physical function, body composition, vascular indicators, health-related indicators, lifestyle factors, or questionnaire-based measures. Individuals from whom consent for study participation can be obtained from both the participant and a parent or guardian. Key exclusion criteria - Individuals judged by the principal investigator or co-investigators to be unsuitable for participation in this study. Individuals who are judged to have difficulty participating in the BONE program, foot bone-strengthening program, exercise, usual activity, measurements, surveys, or assessments for safety reasons. Individuals judged to have difficulty participating in the intervention, measurements, surveys, or assessments due to conditions related to the foot, lower limbs, bones, muscles, joints, nervous system, cardiovascular system, or other health conditions. Individuals from whom consent for study participation cannot be obtained from the participant or a parent or guardian. Individuals otherwise judged to be unsuitable for participation according to the study protocol. 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=R000070226

Disclaimer: Curated by HT Syndication.