UMIN-CTR Clinical Trial

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

healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

physical measurements, laboratory data, ankle brachial pressure index

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

hkawano@nagasaki-u.ac.jp

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

Email

hkawano@nagasaki-u.ac.jp

Institute

Nagasaki University Graduate School of Biomedical Sciences

Institute

Department

Personal name

Organization

medical office expense

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nagasaki University Graduate School of Biomedical Sciences

Address

Sakamoto1-7-1, Nagasaki

Tel

0958197288

Email

hkawano@nagasaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

07

Month

24

Day

URL releasing protocol

PubMed

Publication of results

Published

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

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 related information

Retrospective study
Research participants were randomely selected from participants in this festival without any diseases pointed out by medical check.

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