UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027869 |
|---|---|
| Receipt number | R000031932 |
| Scientific Title | Physical activity intervention at Hairdresser/Barber |
| Date of disclosure of the study information | 2017/06/22 |
| Last modified on | 2022/06/30 15:05:07 |
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Basic information
Public title
Physical activity intervention at Hairdresser/Barber
Acronym
Physical activity intervention at Hairdresser/Barber
Scientific Title
Physical activity intervention at Hairdresser/Barber
Scientific Title:Acronym
Physical activity intervention at Hairdresser/Barber
Region
| Japan |
Condition
Condition
Healthy adults (customers in hairdresser/barber)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, aging ratio reaches 30% in 2025. Successful aging is important issue in this super aging society. Improving physical activity is a corner stone to prevent disease and maintain health. Although factors for improving physical activity and effectiveness of physical activity are well studied, the study of effective intervention to improve physical activity is not well identified. Hairdresser/Barber is dotted in community. People visit regularly. Our study idea is to improve physical activity by using the strength of Hairdresser/Barber. In Akita prefecture, statistically, most populating with older people in Japan, sport population is worst second. On the other hand, Hairdresser/Barber ratio is number one in Japan. Therefore, our study aims to improve physical activity by using Hairdresser/Barber.
Basic objectives2
Others
Basic objectives -Others
Effectiveness
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity
Frailty
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Educate about physical activity
Interventions/Control_2
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
1) regular customer
2) age is between 40 and 79 year old
3) 5 participants from each age group
(40s, 50s, 60s, 70s)
Key exclusion criteria
No specific exclusion criteria. But, customer with pacemaker needs to be aware that internet system is used by Wi-Fi system. Although Wi-Fi is set at the corner of shop with good distance, there is an electromagnetic wave when using a tablet. If the participants concern about this, they should not participate with this project.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Makabe |
Organization
Akita University Graduate School of Health Sciences
Division name
Department of Clinical Nursing
Zip code
0108543
Address
1-1-1, Hondo, Akita, 010-8543, Japan
TEL
0188846539
1smakabe@gipc.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Makabe |
Organization
Akita University Graduate School of Health Sciences
Division name
Department of Clinical Nursing
Zip code
0108543
Address
1-1-1, Hondo, Akita, 010-8543, Japan
TEL
0188846539
Homepage URL
1smakabe@gipc.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Toyota research foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita Univeristy Graduate School of Health Sciences
Address
Akita city, 1-1-1
Tel
0188846028
soken@hos.akita-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
| 2017 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
https://link.springer.com/content/pdf/10.1007%2Fs43545-022-00361-4.pdf
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/content/pdf/10.1007%2Fs43545-022-00361-4.pdf
Number of participants that the trial has enrolled
45
Results
Female customers, and highly educated customers were interested in participating in the study. Frailty status was identifed and found to be unrelated to age. Further, the frailty status was not afected by the intervention. Nevertheless, customers assessed as frail were advised to visit the regional comprehensive support center for further frailty assessment and enroll in a prevention program.
Results date posted
| 2022 | Year | 06 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The majority were women (82%), employed (93%), had high school education or above (62%), with a median age of 53.0 years. Most participants could sleep (73%), did not smoke (91%), answered positively for alcohol intake (40%), and were currently undergoing medical treatment (51%). The majority of participants had pain in more than three body parts. The median physical activity score was 4830.0.
Participant flow
To participate in this study, customers were recruited between August and December 2018
by the owners.
Adverse events
None
Outcome measures
Frailty
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 22 | Day |
Last modified on
| 2022 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031932
