UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062603 |
|---|---|
| Receipt number | R000071599 |
| Scientific Title | Training Older Instructors to Implement Relaxation Programs for Frailty Prevention in the Community |
| Date of disclosure of the study information | 2026/08/18 |
| Last modified on | 2026/08/18 15:34:09 |
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Basic information
Public title
Implementation and evaluation of relaxation programs among elderly people in the community
Acronym
Preventing frailty among Older in the community
Scientific Title
Training Older Instructors to Implement Relaxation Programs for Frailty Prevention in the Community
Scientific Title:Acronym
Relaxation Programs for Frailty Prevention in the Community
Region
| Japan |
Condition
Condition
Older People
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to train older instructors to conduct relaxation programs for frailty prevention within the community and to establish the relaxation programs implemented by these instructors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assess the self-monitoring sheet before and after the intervention.
Key secondary outcomes
Blood pressure, pulse
Interview Details after practicing Progressive Muscle Relaxation
Content of the summary
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A relaxation program (based on the framework of progressive muscle relaxation, including practical exercises) will be conducted.
Interventions/Control_2
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Living at home 2.If suffering from respiratory or circulatory disorders, the condition must be stable.
Key exclusion criteria
1.Individuals currently hospitalized 2.Individuals diagnosed with dementia 3.Individuals for whom the implementation of a relaxation program is difficult 4.Individuals with hypotension for whom a relaxation response is contraindicated 5.Individuals experiencing severe physical symptoms following surgery or chemotherapy.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shiho |
| Middle name | |
| Last name | Ikemata |
Organization
Aichi Prefectural University
Division name
School of Nursing & Health
Zip code
463-8502
Address
Tohgoku, Kamishidami, Moriyama-ku, Nagoya-city, Aichi
TEL
0527787135
ikemata@nrs.aichi-pu.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Ikemata |
Organization
Aichi Prefectural University
Division name
School of Nursing & Health
Zip code
463-8502
Address
Tohgoku, Kamishidami, Moriyama-ku, Nagoya-city, Aichi
TEL
0527787135
Homepage URL
ikemata@nrs.aichi-pu.ac.jp
Sponsor or person
Institute
Aichi Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Aichi Prefectural University
Address
Tohgoku, Kamishidami, Moriyama-ku, Nagoya-city, Aichi
Tel
0527787135
ikemata@nrs.aichi-pu.ac.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
| 2026 | Year | 08 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 08 | Month | 18 | Day |
Last modified on
| 2026 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071599
