UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051992 |
|---|---|
| Receipt number | R000059042 |
| Scientific Title | Effects of Laughter Yoga on physical activity levels in the geriatric health services facility |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2024/12/29 19:12:54 |
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Basic information
Public title
Effects of Laughter Yoga on physical activity levels in the geriatric health services facility
Acronym
Effects of Laughter Yoga on physical activity levels in the geriatric health services facility
Scientific Title
Effects of Laughter Yoga on physical activity levels in the geriatric health services facility
Scientific Title:Acronym
Effects of Laughter Yoga on physical activity levels in the geriatric health services facility
Region
| Japan |
Condition
Condition
Persons admitted to the geriatric health services facility
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that an 8-week laughter yoga intervention for residents of the geriatric health services facility will increase physical activity after the intervention compared to usual care alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity assessment using an accelerometer
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
8-week laughter yoga intervention
Interventions/Control_2
Normal Care
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
Persons admitted to the geriatric health services facility.
Key exclusion criteria
Those who have difficulty in conducting various types of evaluations such as questionnaires.
Disabled elderly persons with a daily living independence level of C.
Those who are not expected to be admitted for more than 8 weeks
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Naohiro |
| Middle name | |
| Last name | Kubota |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo, Kitakatsuragi, Nara 635-0832
TEL
0745-54-1601
f3942691@kio.ac.jp
Public contact
Name of contact person
| 1st name | Naohiro |
| Middle name | |
| Last name | Kubota |
Organization
the geriatric health services facility Yumesaki Hakujuen
Division name
Rehabilitation Division
Zip code
672-2135
Address
77-9,tsukamoto,yumesaki,himezi,hyogo
TEL
079-335-3320
Homepage URL
https://www.junshin.or.jp/yumesakihakujuen.html
f3942691@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umami-naka, Koryo, Kitakatsuragi, Nara 635-0832
Tel
0745-54-1601
kansa@kio.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 | 08 | Month | 31 | 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
30
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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 23 | 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 | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059042
