Tokyo, Sept. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058956) titled 'A Community-based Long-term Care Prevention Program Using a Cybernic System: A Pre-Post Study with the Wearable Cyborg HAL' on Sept. 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 independent older adults (independent in daily life, with or without chronic lifestyle-related diseases), older adults eligible for long-term care prevention programs, and older adults with pre-frailty
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the effects of a long-term care and frailty prevention program using a Cybernic System (Wearable Cyborg HAL and Cyvis100) in collaboration with a local municipality, targeting community-dwelling older adults (healthy, eligible for care prevention, or pre-frail). The program involves weekly exercise sessions for approximately one to two months, in which participants wear the HAL device to perform exercises in rhythm with music, while the Cyvis100 is used to collect physiological data during exercise. Physical function data and mental health indicators will be measured before and after the program to assess the effects of the intervention.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Perform the exercise regimen with the lumbar-type Hybrid Assistive Limb (HAL) attached.
Eligibility:
Age-lower limit - 60
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Participant Condition
Community-dwelling older adults who are independent in their activities of daily living (ADL) and are capable of participating in local community activities or health classes.
Individuals may have lifestyle-related diseases such as hypertension, diabetes, or dyslipidemia, as long as they are not prohibited by a physician from engaging in daily activities or light to moderate exercise.
(2) Age
Approximately 65 years or older at the time of enrollment.
(3) Gender
No restrictions.
(4) Health-related Conditions
Individuals who are able to maintain a standing position and do not have severe musculoskeletal, neurological, or cardiovascular diseases that would interfere with program participation.
(5) Informed Consent
Individuals who have received both oral and written explanations about the purpose and content of the study, have fully understood them, and have provided written informed consent of their own free will.
Key exclusion criteria - Since the participants are recruited from local health promotion classes, it is assumed that all individuals are cleared to engage in physical activity. However, the following conditions should be confirmed, and individuals meeting any of them should be excluded:
Physician restriction: Individuals who are prohibited or cautioned against physical activity by their doctor.
Difficulty with independent walking or standing, or high risk of falling (e.g., 2 or more falls in the past 6 months).
Cardiovascular or respiratory instability: Resting blood pressure >= 180/110 mmHg, resting heart rate >= 120 bpm, unstable angina, heart failure (NYHA class III-IV), use of home oxygen, etc.
Acute phase, infection, or severe pain: Fever >= 37.5 C, active infection, stroke/fracture/surgery in the past 3 months, or joint pain rated >= 7 out of 10 on the NRS scale at rest or with light load.
Device incompatibility: Presence of implantable electrical devices that are incompatible or contraindicated with HAL/Cyvis100, allergy to electrodes or gel, or skin lesions at the application site.
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 22 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067239
Disclaimer: Curated by HT Syndication.
