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 (UMIN000059446) 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 - The Japan Acupuncture & Moxibustion Association

Condition: Condition - Non-frail elderly adult volunteers Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to dispatch acupuncturists to community centers to provide acupuncture treatments for various health issues among the elderly, while also instructing them in self-care through acupoint stimulation. This aims to improve the QOL of the elderly and implement the utilization of community centers as new health resources in a socially practical manner. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Acupuncture Treatment Group: Acupuncture treatment is added to the recreational activities conducted at the salon, and participants are instructed in self-care based on Eastern medicine principles. The frequency of acupuncture treatment will be once every two weeks, for a total of four interventions. The acupuncture treatment method will be based on local treatment targeting the participants' primary complaints, using standard techniques.

The needles used are Seirin Co., Ltd. JSP needles, 0.14-0.25mm thick and 30-60mm long. If the patient is in severe pain or has significant muscle hardening, the acupuncturist may decide to use electroacupuncture in addition. When using adhesive acupuncture needles, Seirin Co., Ltd. Pinex ZERO 0.3mm needles are used. In addition, when fine needles are not possible or as an additional treatment, pin needles, round needles, and roller needles are also used depending on the patient. As a general rule, pedestal moxibustion needles (such as Yamasho and Chosho moxibustion needles) are used. Moxibustion should be used with caution on patients with diabetes or those taking immunosuppressants such as steroids. Oriental medical self-care is instructed on patients using a guide published by the Japan Acupuncture and Moxibustion Association. The equipment used for self-care by the target individuals will be Painex Zero (a tape-attached contactor [non-invasive acupuncture device for home use] manufactured by Seirin Co., Ltd.) and pedestal moxa (such as Sennenkyu Rainbow (Sennenkyu Co., Ltd.)). Those who provide acupuncture and moxibustion treatments and self-care instruction will be licensed as a Japanese acupuncturist or moxibustion practitioner, have held the license for more than five years, and be members of the Japan Acupuncture and Moxibustion Association or the All Japan Acupuncture and Moxibustion Society. Interventions/Control_2 - Recreation Groups(Control Group): Each salon conducts exercise-based and activity-based recreation sessions. Recreation sessions are held once every two weeks as a general rule. Exercise-based recreation includes activities such as walking, calisthenics, training, and ground golf. Activity-based recreation includes painting, cooking, handicrafts, and tea gatherings.

Eligibility: Age-lower limit - 65 years-old

Gender - Male and Female Key inclusion criteria - (1) Those aged 65 or older (2) Those who can attend a day care facility (3) Gender is not an issue Key exclusion criteria - (1) Individuals certified as requiring assistance or nursing care (2) Individuals with mental disorders or symptoms that make communication difficult (3) Individuals with poorly controlled cancer (4) Individuals already receiving acupuncture, osteopathic, or massage treatment at the time of study enrollment Target Size - 140

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 08 Month 30 Day Date of IRB - 2025 Year 10 Month 17 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=R000067985

Disclaimer: Curated by HT Syndication.