UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018416 |
|---|---|
| Receipt number | R000021319 |
| Scientific Title | Physical and health check of participants before and after the training for Nagasaki Kunchi |
| Date of disclosure of the study information | 2015/07/24 |
| Last modified on | 2023/01/30 18:16:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Physical and health check of participants before and after the training for Nagasaki Kunchi
Acronym
Physical and health check in Nagasaki Kunchi
Scientific Title
Physical and health check of participants before and after the training for Nagasaki Kunchi
Scientific Title:Acronym
Physical and health check in Nagasaki Kunchi
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make the reference data on practice and decision for bearers of float in Nagasaki Kunchi
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical measurements, laboratory data, ankle brachial pressure index
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
healthy adult participants
Key exclusion criteria
participants who were not able to continue to practice
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kawano |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197288
hkawano@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kawano |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Cardiovascular Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197288
Homepage URL
hkawano@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
medical office expense
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
Nagasaki University Graduate School of Biomedical Sciences
Address
Sakamoto1-7-1, Nagasaki
Tel
0958197288
hkawano@nagasaki-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
| 2015 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
PubMed
Publication of results
Published
Result
URL related to results and publications
Intern Med . 2017;56(1):11-16
Number of participants that the trial has enrolled
34
Results
In the hypertensive participants, the BW, BMI, and body fat percentage, SBP, DBP, PR, PP, and API were significantly decreased after the training. The bearing power was significantly increased, but the muscle volume did not change significantly. In the normotensive participants, the SBP, DBP, PR, API, and AVI did not significantly change, but the BW, BMI and body fat percentage were significantly decreased, and the PP, muscle volume, and bearing power were significantly increased.
Results date posted
| 2023 | Year | 01 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among the 38 bearers of the Shachidaiko from Ginya Town that participated in the 2014 Nagasaki Kunchi, 34 healthy men ranging in age from 20 to 49 years (mean age 35.7 years) and without any apparent diseases were examined after agreeing to participate in this study and providing informed consent.
Participant flow
The following parameters were assessed before and nine months after the beginning of the training: body weight (BW), body mass index (BMI), body fat percentage, muscle volume, systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate (PR), pulse pressure (PP), arterial pressure volume index (API) and arterial velocity pulse index (AVI).
Adverse events
none
Outcome measures
body weight (BW), body mass index (BMI), body fat percentage, muscle volume, systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate (PR), pulse pressure (PP), arterial pressure volume index (API) and arterial velocity pulse index (AVI).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Retrospective study
Research participants were randomely selected from participants in this festival without any diseases pointed out by medical check.
Management information
Registered date
| 2015 | Year | 07 | Month | 24 | Day |
Last modified on
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021319
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/07/29 | おくんち⑮実施計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/07/29 | 担ぎ手のみ前後比較全員非高血圧者BMIあり名前削除.xls |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/07/29 | 担ぎ手のみ前後比較全員非高血圧者BMIあり名前削除.xls |
Single case data URL
Value
https://center6.umin.ac.jp/ice/21319
