Detection of mental and physical conditions with heart rate variability

ISRCTN	ISRCTN11112963
DOI	https://doi.org/10.1186/ISRCTN11112963
Secondary identifying numbers	UMIN000046352

Submission date: 08/05/2024
Registration date: 09/05/2024
Last edited: 27/01/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims.
Evaluating fatigue is essential in assessing mental, physical, and occupational health. However, there is no conclusive evidence of the usefulness of heart rate variability (HRV) in assessing mental fatigue. The aim of this study is to evaluate mental fatigue using HRV.

Who can participate?
Men and women aged 20 to 65 years who have received annual health check-ups and have been found to have no health concerns.

What does the study involve?
Participants are randomly allocated to either complete simple calculation tasks or to take a rest. HRV is measured using a wearable ECG monitor system. Fatigue and mood are measured before and after the intervention

What are the possible benefits and risks of participating?
Participants receive reasonable compensation. Participating takes about 3 hours.

Where is the study run from?
1. KYOCERA Corporation (Japan)
2. Kanazawa University (Japan)

When is the study starting and how long is it expected to run for?
April 2021 to September 2022

Who is funding the study?
1. KYOCERA Corporation (Japan)
2. Kanazawa University (Japan)

Who is the main contact?
Prof. Hiroaki Yoshikawa, hiroaki@staff.kanazawa-u.ac.jp

Study website

Contact information

Prof Hiroaki Yoshikawa
Public, Scientific, Principal Investigator

Kakumamachi
Kanazawa
920-1192
Japan

ORCID ID	0000-0002-6350-5183
Phone	+81 (0)76 264 5254
Email	hiroaki@staff.kanazawa-u.ac.jp

Study information

Study design	Single-center interventional randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Research on mental and physical conditions detected by heart rate variability analysis
Study acronym	RMPCDHRVA
Study objectives	Heart rate variability can detect mental fatigue.
Ethics approval(s)	Approved 16/06/2021, Kanazawa University Medical Ethics Review Committee (13-1 Takaramachi, Kanazawa, 920-8640, Japan; +81 (0)76 265 2100; rinri@adm.kanazawa-u.ac.jp), ref: 2021-031 (3720)
Health condition(s) or problem(s) studied	Detection of mental fatigue in healthy adults
Intervention	Participants were randomized in a 1:1 ratio to the intervention or control groups using a computer-generated random number sequence for simple random allocation. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent research team member. The researchers compared heart rate variability (HRV) indexes after calculations with those after rest. They used Uchida-Kraepelin test (UKT) sheets for loading calculation tasks. The UKT is a serial addition test requiring participants to perform calculations as fast and accurately as possible within 30 min. This was achieved using pre-printed paper containing 15 lines of random, single-digit, horizontally aligned numbers. Participants were instructed to begin a new line for each minute of the test regardless of their position on the content line. Each line contained an excess of calculations such that the subjects could not finish any line for a particular minute before being prompted to move on to the start of the next minute by the examiner’s prompting. This test is usually performed for repeated 15 min of work and 5 min rest cycles. The researchers adopted four cycles. They used UKT sheets only to load mental fatigue and did not evaluate the scores. As a control, they asked participants to take a rest. The researchers prepared easy and calm books so participants could read them. The duration of rest was 80 minutes, adjusted to calculation tasks.
Intervention type	Behavioural
Primary outcome measure	Heart rate variability (HRV) indexes measured using wearable electrocardiogram (ECG) devices before and after the intervention
Secondary outcome measures	1. Fatigue measured using the visual analog scale (VAS) before and after the intervention 2. Mood measured using Profile of Mood States 2nd Edition (POMS2) before and after the intervention
Overall study start date	01/04/2021
Completion date	30/09/2022

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	20 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	150
Total final enrolment	140
Key inclusion criteria	1. Received annual health check-ups and found to have no health concerns 2. Aged 20-65 years
Key exclusion criteria	1. Implanted cardiac pacemaker 2. Arrhythmia 3. Taking medicine that affects autonomic nervous functions, such as a beta-blocker
Date of first enrolment	08/06/2022
Date of final enrolment	06/08/2022

Locations

Countries of recruitment

Japan

Study participating centres

Kanazawa University Health Service Center

Kakumamachi
Kanazawa
920-1192
Japan

KYOCERA Corporation

3-7-1 Minatomirai
Yokohama
220-0012
Japan

Sponsor information

Kyocera (Japan)
Industry

3-7-1 Minatomirai
Yokohama
220-0012
Japan

Phone	+81 (0)45 605 7100
Email	soudan@adm.kanazawa-u.ac.jp
Website	http://global.kyocera.com/
"ROR"	https://ror.org/025y1g718

Kanazawa University
University/education

Kakuma-machi
Kanazawa
920-1192
Japan

Phone	+81 (0)76 264 5111
Email	hiroaki@staff.kanazawa-u.ac.jp
Website	https://www.kanazawa-u.ac.jp/
"ROR"	https://ror.org/02hwp6a56

Funders

Funder type

Industry

Kyocera (Japan)

No information available

Kanazawa University
Government organisation / Universities (academic only)

Alternative name(s): 金沢大学, 金大, Kanazawa-dai, Kindai, KU
Location: Japan

Results and Publications

Intention to publish date	01/12/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
Publication and dissemination plan	Planned publication in a peer-reviewed journal.
IPD sharing plan	The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. The type of data that will be shared are the data obtained during the study in a spreadsheet format, and the approval form of the ethical committee.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		24/01/2025	27/01/2025	Yes	No

Editorial Notes

27/01/2025: Publication reference added.
25/10/2024: The intention to publish date was changed from 01/12/2024 to 01/12/2025.
08/05/2024: Study's existence confirmed by the Kanazawa University Medical Ethics Review Committee.