UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050706 |
|---|---|
| Receipt number | R000057769 |
| Scientific Title | Effects of group recreation on cerebral blood flow |
| Date of disclosure of the study information | 2023/03/30 |
| Last modified on | 2023/09/28 10:30:16 |
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Basic information
Public title
Effects of group recreation on cerebral blood flow
Acronym
Effects of group recreation on cerebral blood flow
Scientific Title
Effects of group recreation on cerebral blood flow
Scientific Title:Acronym
Effects of group recreation on cerebral blood flow
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effects of cognitive rehabilitation (group recreation) by actually practicing cognitive rehabilitation (group recreation) in long-term care insurance facilities and day services, and visualizing and quantifying it using cerebral blood flow. Specifically, since the data obtained so far from the fNIRS cerebral blood flow measurement device suggest that relationships with others may enhance the effect, we will verify the effect of recreation targeting groups rather than individual recreation so far. Furthermore, we will explore what kind of ingenuity is necessary to practice group recreation efficiently.
The Clinical Practice Guideline for Dementia states that "the effects of non-drug therapies have been confirmed to be significant in terms of improving cognitive function, but the results are inconsistent and the evidence is insufficient." Non-drug therapies such as validation therapy, exercise therapy, massage, reminiscence, music therapy, and supportive psychotherapy are recommended, but the evidence is also scarce and high-quality evidence is needed for the future. This study visualizes and quantifies the effects of unexplained non-drug therapies, especially recreation in groups, and verifies their effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cerebral blood flow during solo recreation and cerebral blood flow during group recreation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Facility staff who are collaborators will wear fNIRS cerebral blood flow measurement devices on the subjects. The subject stares at a plain construction paper for 90 seconds. Collect numerical values obtained from measuring devices. (Previous studies have shown that staring at plain construction paper for 90 seconds stabilizes the cerebral blood flow waveform of fNIRS back to the reference line.) The subject performs a 10-minute solo recreation with the facility staff and collects the values obtained from the measuring device. During the recreation, the researchers use a video camera to film and record the subjects' words and actions.
Interventions/Control_2
Participants will rest for 10 minutes after performing the solo recreation, and the collaborator, facility staff, will stare at plain construction paper for 90 seconds after attaching the fNIRS cerebral blood flow measurement device to the subjects. Collect numerical values obtained from measuring devices. Subjects perform similar recreation while interacting with other subjects in a group (group of 4 people) with facility staff, and collect the numerical values obtained from the measuring device. During group recreation, researchers use video cameras to film and record the subjects' words and actions.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly persons aged 65 years or older who live in Takatsuki City and who do not interfere with their daily lives in terms of vision, hearing, or language ability. It is intended for those who use day services conducted at research cooperation facilities. Regarding selection, the researcher informs the person in charge of the facility who is the research collaborator in advance of the selection criteria of the target person, and the researcher explains in writing to the person introduced by the facility staff at the facility and obtains consent.
Key exclusion criteria
Those with higher brain dysfunction due to a history of psychiatric or cerebrovascular disease, and those with an MMSE (Mini Mental State Examination) score of 23 or less are excluded.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Kubota |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Nursing
Zip code
569-0095
Address
7-6 Hacchonishi-machi Takatsuki City, Osaka
TEL
072-684-7223
masakazu.kubota@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Kubota |
Organization
Osaka Medical and Pharmaceutical University
Division name
Faculty of Nursing
Zip code
569-0095
Address
7-6 Hacchonishi-machi Takatsuki City, Osaka
TEL
072-684-7223
Homepage URL
masakazu.kubota@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
7-6 Hacchonishi-machi Takatsuki City, Osaka
Tel
072-684-7223
masakazu.kubota@ompu.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
| 2023 | Year | 03 | Month | 30 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057769
