UMIN-CTR Clinical Trial

Public title

Distribution of heart rate variability in the upper grades of elementary school who can attend school

Acronym

NHRV test

Scientific Title

Distribution of heart rate variability in the upper grades of elementary school where school can be attended

Scientific Title:Acronym

NHRV test

Region

Japan

Condition

Elementary school seniors who can attend school

Classification by specialty

Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In children unable to attend school, changes in heart rate variability (HRV) over time can be observed . There are no reports of normal HRV values in children recorded using the types of HRV-measuring instruments currently available in Japan. In order to identify the abnormalities present in the HRV of children who refuse to attend school, data for normal values were gathered first.

Basic objectives2

Others

Basic objectives -Others

It is already known that measured HRV values can change due to age, posture, and the presence or absence of heart failure, diabetes mellitus, and ischemic heart disease. In addition to the above-mentioned conditions, mood disorders are also reported to cause changes in HRV. Refusal to attend school in children is often associated with mood disorders. To identify HRV abnormalities in children who refuse to attend school, the distribution of HRV in children in the upper grades of elementary school who attend school was examined first.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

HRV is measured for elementary school seniors, CVRR obtained from SDNN and Mean from the time series analysis, VLF, LF, HF, Total Power, etc. from the frequency analysis by AR-Power Spectrum (Non-Detrend), naturally converted numerical values are added, and the average value and standard deviation are obtained.

Key secondary outcomes

Using the results of frequency analysis, we confirm the conditions for obtaining a normal distribution for raw data and natural random conversion values.

Study type

Others,meta-analysis etc

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

10

years-old

<=

Age-upper limit

12

years-old

>

Gender

Male and Female

Key inclusion criteria

Elementary school children who can attend school and take regular classes

Key exclusion criteria

Children who are unable to take regular classes and are only in the infirmary

Target sample size

28

Name of lead principal investigator

1st name	Mitsuru
Middle name
Last name	Ikeya

Organization

Ikeya Clinic

Division name

Dean

Zip code

436-0088

Address

2-10-14 Katsuragaoka,Kakegawa City,Shizuoka Pref.,Japan,436-0088

TEL

0537-22-0433

Email

ikeya-25@fancy.ocn.ne.jp

Name of contact person

1st name	Mitsuru
Middle name
Last name	Ikeya

Organization

Ikeya Clinic

Division name

Dean

Zip code

436-0088

Address

2-10-14 Katsuragaoka,Kakegawa City,Shizuoka Pref.,Japan,436-0088

TEL

0537-22-0433

Homepage URL

Email

ikeya-25@fancy.ocn.ne.jp

Institute

Ikeya Clinic

Institute

Department

Personal name

Organization

Ikeya Clinic

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Chutoen General Medical Center

Address

1-1 Shobugaike,Kakegawa City,Shizuoka Pref.,Japan,436-3555

Tel

-0537-21-0555

Email

rinshokenkyu@chutoen-hp.shizuoka.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

池谷医院（静岡県）

Date of disclosure of the study information

2020

Year

12

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

28

Results

HRV measurements were performed in 28 children with a mean age of 11 years at school using a portable electrocardiographic monitor. The normality of the results and of the natural logarithms of the numerical values was examined. A normal distribution was only confirmed for CVRR and for HF subject to natural logarithm transformation.

Results date posted

2020

Year

09

Month

13

Day

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

Recruitment status

Completed

Date of protocol fixation

2019

Year

12

Month

02

Day

Date of IRB

2019

Year

12

Month

02

Day

Anticipated trial start date

2020

Year

09

Month

14

Day

Last follow-up date

2020

Year

10

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

HRV was measured in patients with dyslipidia at an average age of 60 years.
The mean values (and standard deviations) for HRV measured for 5 minutes subjected to natural logarithm transformation were as follows: the coefficient of variance of RR intervals (CVRR) was 1.13(0.35); the total power was 6.07 (0.90); the very low frequency (VLF) band was 5.66 (1.00); the low frequency (LF) band was 4.16 (0.90); and the high frequency (HF) band was 3.99 (0.90). All test items showed normality distribution.

Registered date

2020

Year

09

Month

29

Day

Last modified on

2020

Year

09

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044520