UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059446 |
|---|---|
| Receipt number | R000067985 |
| Scientific Title | Research Project on the Effective Utilization of Community-Based Programs in Collaboration with Acupuncturists for Frailty Prevention |
| Date of disclosure of the study information | 2025/10/17 |
| Last modified on | 2025/10/17 18:11:46 |
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Basic information
Public title
Research Project on the Effective Utilization of Community-Based Programs in Collaboration with Acupuncturists for Frailty Prevention
Acronym
Preventing frailty using acupuncturists(PFUA)
Scientific Title
Research Project on the Effective Utilization of Community-Based Programs in Collaboration with Acupuncturists for Frailty Prevention
Scientific Title:Acronym
Preventing frailty using acupuncturists(PFUA)
Region
| Japan |
Condition
Condition
Non-frail elderly adult volunteers
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjects' Quality of Life Assessment (Short Form-8 Health Survey)
Key secondary outcomes
1. QOL Assessment (QDIS-1)
2. Visual Analogue Scale for Subject Complaints (Acupuncture Intervention Complaints)
3. Basic Checklist
4. Depression Assessment (PHQ-9)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 120 | 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 sample size
140
Research contact person
Name of lead principal investigator
| 1st name | TOSHIHIRO |
| Middle name | |
| Last name | KOYAMA |
Organization
The Japan Acupuncture & Moxibustion Association
Division name
Head Office
Zip code
1700005
Address
3-44-14 Minami-otsuka, Toshima-ku, Tokyo
TEL
03-5944-5089
harikyuisshin@gmail.com
Public contact
Name of contact person
| 1st name | MASAO |
| Middle name | |
| Last name | SUZUKI |
Organization
Research Institute affiliated with Fukushima Medical University Aizu Medical Center
Division name
Laboratory of Kampo Medicine
Zip code
969-3492
Address
21-2 Maed, Tanazawa, Katou-machi, Aizuwakamatsu City, Fukushima, Japan
TEL
0242752100
Homepage URL
masuzuki@fmu.ac.jp
Sponsor or person
Institute
The Japan Acupuncture & Moxibustion Association
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Japan Society of Acupuncture and Moxibustion
Address
3-44-14, Minami-otsuka, Toshima-ku, Tokyo 170-0005, Japan
Tel
03-6272-3960
honbu@jsam.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067985
