Clinical Trial: Research Project on the Effective Utilization of Community-Based Programs in Collaboration with Acupuncturists for Frailty Prevention (Japan)

Tokyo, Oct. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059449) titled 'Research Project on the Effective Utilization of Community-Based Programs in Collaboration with Acupuncturists for Frailty Prevention' on Oct. 17.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Japan Acupuncture & Moxibustion Association

Condition: Condition - Elderly people who do not require care Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this research is to implement, in a socially practical manner, the utilisation of community centres as new health resources. This will be achieved by dispatching acupuncturists to these centres to provide acupuncture treatments for various ailments affecting the elderly, alongside instruction in self-care through acupoint stimulation, thereby aiming to enhance the quality of life (QOL) of the elderly. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Acupuncture treatment group: Acupuncture treatment is added to the recreational activities conducted at the salon, with participants being instructed in self-care based on Eastern medicine principles. The frequency of acupuncture treatment is set at once every two weeks, as most salons operate on a bi-weekly schedule. Participants are also required to perform self-care between each acupuncture session. The acupuncture treatment method will be based on localised treatment targeting the participants' primary complaints, using standard techniques. Needles with a diameter of0.14-0.25 mm and a length of 30-60 mm will be used. Furthermore, when the subject experiences severe pain or pronounced muscle hardening, electroacupuncture may be employed at the acupuncturist's discretion. For adhesive needles, circular adhesive needles or similar types will be used. Additionally, where fine needles are unsuitable or as supplementary treatment, finger-pressure needles, en-shin needles, or roller needles may be used according to the subject's condition. Moxibustion will primarily utilise moxa cones. For Oriental medicine-based self-care, guidance shall be provided to the subject using the guide issued by the Japan Society of Acupuncture and Moxibustion. The items used for the subject's self-care shall be adhesive contact electrodes and moxa cones. Those performing acupuncture and moxibustion treatment and providing self-care guidance shall hold a Japanese acupuncturist and moxibustion practitioner licence, have held this licence for at least five years, and be a member of either the Japan Society of Acupuncture and Moxibustion or the All Japan Society of Acupuncture and Moxibustion. Interventions/Control_2 - Recreational group: Each salon conducts physical recreation and activity-based recreation. Physical recreation includes walks, gymnastics, training, and ground golf. Activity-based recreation includes painting, cooking, handicrafts, and tea gatherings. Recreational activities are generally held every two weeks.

Eligibility: Age-lower limit - 65 years-old = Gender - Male and Female Key inclusion criteria - (1) Persons aged 65 or over (2) Persons able to attend the day center (3) Gender is not a factor Key exclusion criteria - (1) Persons certified as requiring support or nursing care. (2) Persons with mental disorders or associated psychiatric symptoms deemed to have impaired communication. (3) Persons with uncontrolled cancer. (4) Persons already receiving treatment at acupuncture clinics, osteopathic clinics, or massage clinics at the time of study enrolment. Target Size - 140

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 08 Month 01 Day Date of IRB - 2025 Year 10 Month 16 Day Anticipated trial start date - 2025 Year 10 Month 19 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=R000067984

Disclaimer: Curated by HT Syndication.