UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059449 |
|---|---|
| Receipt number | R000067984 |
| 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 22:03:20 |
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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
Elderly people who do not require care
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of Life Assessment (SF-8; SF-8 Health Survey)
Mean difference at 8 weeks compared to baseline
Key secondary outcomes
1. Quality of Life Assessment (QDIS-1)
2. Subject's Visual Analogue Scale for 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
Institution is not considered as adjustment factor.
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, 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.
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
| 100 | 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 sample size
140
Research contact person
Name of lead principal investigator
| 1st name | TOSHIHIRO |
| Middle name | |
| Last name | KOYAMA |
Organization
Japan Acupuncture & Moxibustion Association
Division name
Headquarters
Zip code
170-0005
Address
3-44-14 Minami Otsuka, Toshima-ku, Tokyo Japan
TEL
03-5944-5089
info@harikyu.or.jp
Public contact
Name of contact person
| 1st name | TOSHIHIRO |
| Middle name | |
| Last name | KOYAMA |
Organization
Japan Acupuncture & Moxibustion Association
Division name
Headquarters
Zip code
170-0005
Address
3-44-14 Minami Otsuka, Toshima-ku, Tokyo Japan
TEL
03-5944-5089
Homepage URL
info@harikyu.or.jp
Sponsor or person
Institute
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
Ethics Review Committee of 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 | 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 |
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=R000067984
