UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054692 |
|---|---|
| Receipt number | R000058076 |
| Scientific Title | Effects of a laughter program on frail prevention and control: a randomized intervention study |
| Date of disclosure of the study information | 2024/06/18 |
| Last modified on | 2024/06/18 14:56:21 |
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Basic information
Public title
Effects of a laughter program on frail prevention and control: a randomized intervention study
Acronym
Effects of a laughter on frail control: a randomized intervention study
Scientific Title
Effects of a laughter program on frail prevention and control: a randomized intervention study
Scientific Title:Acronym
Effects of a laughter on frail control: a randomized intervention study
Region
| Japan |
Condition
Condition
frailty
Classification by specialty
| Geriatrics | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a laughter program on frailty in this randomized intervention for people with pre-frailty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty (grip strength, oral function) after 12-week intervention.
Key secondary outcomes
Cognitive functions, depressive symptom, QOL, physical function, 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
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Laughter Yoga (1hour, 10 times/12 weeks)
Interventions/Control_2
Lecture about laughter and health (30min, 10 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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who have at least one of the following
1. Fried et al.'s criteria for assessment of frailty (weight loss: 2-3 kg in 6 months, subjective fatigue, decreased physical activity, decreased physical ability (walking speed <1.0 m/sec), decreased muscle strength (grip strength: men <28 Kg, women <18 Kg)
2. Decreased oral function (dry mouth, swallowing, difficulty eating hard foods)
3. cognitive function decline (memory loss)
Key exclusion criteria
acute myocardial infarction
acute stroke
Target sample size
100
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
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
TEL
024-547-1343
Homepage URL
teoohira@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Fukushima Medical University
Address
Hikarigaoka 1, Fukushima-shi, Fukushima -ken, 960-1295 Japan
Tel
024-547-1825
rs@fmu.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 | 06 | Month | 18 | 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
| 2020 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | 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
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058076
