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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027145
Receipt No. R000030171
Scientific Title Effects of laughter therapy on prevention of life-style diseases incident and its complication: a randomized intervention study
Date of disclosure of the study information 2017/04/27
Last modified on 2017/10/16

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Basic information
Public title Effects of laughter therapy on prevention of life-style diseases incident and its complication: a randomized intervention study
Acronym Effects of laughter therapy on life-style diseases: a randomized intervention study
Scientific Title Effects of laughter therapy on prevention of life-style diseases incident and its complication: a randomized intervention study
Scientific Title:Acronym Effects of laughter therapy 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 thier control in this randomized intervention study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Metabolis syndrome (Body weight, waist circumference, blood pressure, HbA1c) after 12-week intervension.
Key secondary outcomes Autonomic nervus function, Depressive symptom, QOL, physical function, dyslipidemia, physical activity, psychological health after 12-week intervension.

Base
Study type Interventional

Study design
Basic design Parallel
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, 8 times/12 weeks)
Interventions/Control_2 Lecture about laughter and health (30min, 8 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
Weist 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 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Ohira
Organization University of Fukushima School of Medicine
Division name Department of Epidemiology
Zip code
Address Hikarigaoka 1, Fukushima-shi
TEL 024-547-1343
Email teoohira@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Ohira
Organization University of Fukushima School of Medicine
Division name Department of Epidemiology
Zip code
Address Hikarigaoka 1, Fukushima-shi
TEL 024-547-1343
Homepage URL
Email teoohira@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka University, Okayama University, Ryukyu University, Chiba University,National Hospital Organizastion Kyoto Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 福島県立医科大学(福島県)、岡山大学(岡山県)、大阪大学(大阪府)、琉球大学(沖縄県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 27 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 Open public recruiting
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 26 Day
Last modified on
2017 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030171

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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