UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053603 |
|---|---|
| Receipt number | R000061164 |
| Scientific Title | Picture Sound book with Ninja-essence targeting older poeple affected by the Fukushima Daiichi nuclear plant accident: Development and evaluation A pilot before and after clinical trial |
| Date of disclosure of the study information | 2024/02/13 |
| Last modified on | 2024/02/13 10:32:33 |
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Basic information
Public title
Picture Sound book with Ninja-essence targeting older poeple affected by the Fukushima Daiichi nuclear plant accident: Development and evaluation
A pilot before and after clinical trial
Acronym
Picture Sound book with Ninja-essence targeting older poeple affected by the Fukushima Daiichi nuclear plant accident: Development and evaluation
A pilot before and after clinical trial
Scientific Title
Picture Sound book with Ninja-essence targeting older poeple affected by the Fukushima Daiichi nuclear plant accident: Development and evaluation
A pilot before and after clinical trial
Scientific Title:Acronym
Picture Sound book with Ninja-essence targeting older poeple affected by the Fukushima Daiichi nuclear plant accident: Development and evaluation
A pilot before and after clinical trial
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Medicine in general | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examined the feasibility of a picture sound book with Ninja-essence; to maintain or improve exercise habits and , physical, and mental conditions that targets the older peopleof the elderly affected by the Fukushima Daiichi Nuclear Power plant accident.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before intervention : Demographic and PTSD checklist
Before and after intervention:
Scores of the toe-grip force, hand-grip strength, and maximum phonation time
Self-reported 20-item questionnaires related to exercise habits and mental condition and physical condition including swallowing function at the time of while answering the question.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The book was delived to participants of Gruop A to practice at home.
Intervention period is 2 months
Interventions/Control_2
The participants of Group b as the control group were instructed to use tools at home as well as regularly performed exercises at a geriatric club meeting.
Intervention period is 2 months
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
Person who experienced evacuation due to the Fukushima nNuclear disaster regardless of whether or not return to the area
Person who is living in an area where the evacuation order had beenwas lifted or an area evaluated within Fukushima Prefecture.
Key exclusion criteria
Individuals who had severe cognitive impairment, were at risk of engaging in risky behavior by readinghaving the book, or failed towere unable to understand the study instructions were excluded.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | kashiko |
| Middle name | |
| Last name | fujii |
Organization
Tokyo Kasei University
Division name
Nursing department
Zip code
3501398
Address
2-15-1 Inaniyama Sayama city Saitama prefecture
TEL
0429521621
fujii-k@tokyo-kasei.ac.jp
Public contact
Name of contact person
| 1st name | kashiko |
| Middle name | |
| Last name | fujii |
Organization
Tokyo Kasei University
Division name
Nursing department
Zip code
3501398
Address
2-15-1 Inaniyama Sayama city Saitama prefecture
TEL
0429521621
Homepage URL
fujii-k@tokyo-kasei.ac.jp
Sponsor or person
Institute
Tokyo Kasei University
Institute
Department
Personal name
Funding Source
Organization
Yuumi Memorial Fundation at Home Health Care
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Information Sciences
Address
4-1Onaridai Wagakaba-ku Chiba City Chiba Prefecture
Tel
0432364710
soaoken@affrs.tuis.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
| 2024 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
not applicalbe URL
Publication of results
Unpublished
Result
URL related to results and publications
not applicable
Number of participants that the trial has enrolled
29
Results
There was a significant difference was observed in both groups of participants between their left and right hand-grip strength,. A significant difference was found in the maximum phonation time in the participants of the group that regularly engaged in exercise, and. Significant p-values were found in the questions regarding swallowing exercises and singing songs or practicing words (p < 0.013 and, p < 0.033 significantly);. Sixteen 16 of among 29 participants reportedly they enjoyed the program.
Results date posted
| 2024 | Year | 02 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age of the participants was 77 (SD 7.618) and 82 (SD = 7.014) years, with 6 males and 15 females in returnees and 2 males and 5 females in evacuees. Of 29 participants, participants answered self-reported diagnosed diseases. Back pain was the highest rate in both groups (24% and 50%, respectively).
Participant flow
Study participants were home-based, older adults (elderly) who moved back to the area within the evacuation zone after postlifting restrictions in Namie Town (Participants who lived in Namie are called returnees thereafter) or those who evacuated and lived in the disaster complex in Nihonmatu
Adverse events
Not applicable
Outcome measures
The scores of the toe-grip force, hand-grip strength, and maximum phonation time
Self-reported 20-item questionnaire related to exercise status and living status including swallowing function
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 13 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061164
