UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050645 |
|---|---|
| Receipt number | R000057706 |
| Scientific Title | Laughter on prevention of life-style diseases incident and its complication: a randomized intervention study |
| Date of disclosure of the study information | 2023/03/23 |
| Last modified on | 2023/03/22 15:41:12 |
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Basic information
Public title
Laughter on prevention of life-style related diseases and its complication: a randomized intervention study
Acronym
Laughter on prevention of life-style related diseases: a randomized intervention study
Scientific Title
Laughter on prevention of life-style diseases incident and its complication: a randomized intervention study
Scientific Title:Acronym
Effects of laughter on life-style diseases: a randomized intervention study
Region
| Japan |
Condition
Condition
Metabolic syndrome, hypertension, diabetes mellitus, dyslipidemia, obesity
Classification by specialty
| Endocrinology and Metabolism | Psychosomatic Internal Medicine | Geriatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of laughter therapy on lifestyle-related diseases and their control in this randomized intervention study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Metabolic syndrome (Body weight, waist circumference, blood pressure, HbA1c) after 12-week intervention.
Key secondary outcomes
Autonomic nerves function, Depressive symptom, QOL, physical function, dyslipidemia, physical activity, psychological health after 12-week intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Laughter Yoga (1hour, 12times/12 weeks)
Interventions/Control_2
Lecture about laughter and health (30min, 12 times/12 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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
BMI >=25kg/m2 or
Waist circumference >=85cm for men >=90cm for women or
SBP >=130mmHg or DBP >=85mmHg or
HbA1c >=5.6% or
TG >=150mg/dL or HDL cholesterol<40mg/dL
or Medication use (hypertension, diabetes mellitus, or dyslipidemia)
Key exclusion criteria
acute myocardial infarction
acute stroke
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ohira |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Epidemiology
Zip code
960-1295
Address
Hikarigaoka 1, Fukushima-shi, Fukushima-ken, 960-1295 Japan
TEL
024-547-1343
teoohira@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ohira |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of Epidemiology
Zip code
960-1295
Address
Hikarigaoka 1, Fukushima-shi, Fukushima-ken, 960-1295 Japan
TEL
024-547-1343
Homepage URL
teoohira@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka University, Okayama University, Ryukyu University, Chiba University, National Hospital Organization Kyoto Medical Center
Name of secondary funder(s)
Japan Agency for Medical Research and Development
IRB Contact (For public release)
Organization
Ethical Review Board of Osaka University Hospital
Address
Yamadaoka 2-2, Suita-shi, 565-0871, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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 | 23 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | 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 | 22 | Day |
Last modified on
| 2023 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057706
