Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061890) titled 'Exploratory Intervention Study of a Group Exercise Program Using the Hybrid Assistive Limb (HAL) for Community-Dwelling Older Adults: Focusing on Individuals at Risk of Frailty and Mild Cognitive Impairment' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tohoku University

Condition: Condition - Community-dwelling older adults at risk of frailty, mild cognitive impairment, or physical function decline Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This exploratory intervention study aims to examine the effects of a group exercise program using the lumbar type Hybrid Assistive Limb (HAL) in community-dwelling older adults at risk of frailty, mild cognitive impairment, or physical function decline. Physical function, health-related outcomes, and cognitive function will be assessed before and after the intervention, while Cyvis100 and accelerometer-based measurements will be used to monitor physical activity during the program. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Participants will perform a group exercise program while wearing the lumbar-type Hybrid Assistive Limb (HAL). The program will be conducted once weekly for 10 sessions (8 exercise sessions) and will include stretching, sit-to-stand exercises, balance training, and stepping/walking exercises.

Eligibility: Age-lower limit - 60 years-old = Gender - Male and Female Key inclusion criteria - 1.Community-dwelling older adults who participated in a community health assessment program conducted by Ami Town, Japan. 2.Individuals identified as being at risk of frailty, mild cognitive impairment, or physical function decline based on assessment results. 3.Aged 60 to 90 years at enrollment. 4.Able to participate in a group exercise program. 5.Able to understand the study procedures and provide written informed consent. Key exclusion criteria - 1.Individuals prohibited from exercise by their physician. 2.Individuals with severe cardiovascular, respiratory, neurological, or musculoskeletal conditions that would make participation unsafe. 3.Individuals who experienced myocardial infarction, stroke, fracture, surgery, or other major medical events within the previous three months. 4.Individuals with severe balance impairment or frequent falls that would make safe participation difficult. 5.Individuals unable to wear the HAL device or assessment equipment. 6.Individuals unable to understand the study procedures or provide valid informed consent. 7.Any other individual judged unsuitable by the principal investigator. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 19 Day Anticipated trial start date - 2026 Year 09 Month 20 Day Last follow-up date - 2027 Year 09 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070814

Disclaimer: Curated by HT Syndication.