UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of physical exercise capacity using heart rate and SpO2 recovery
Acronym	Evaluation of physical exercise capacity using heart rate and SpO2 recovery
Scientific Title	Evaluation of physical exercise capacity using heart rate and SpO2 recovery
Scientific Title:Acronym	Evaluation of physical exercise capacity using heart rate and SpO2 recovery
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine indices that can be used to evaluate physical exercise capacity in short time and at low intensity
Basic objectives2	Others
Basic objectives -Others	Exploration of indicators
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Exercise intensity dependence of physical exercise capacity indices
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	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Exercise tolerance
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	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy subjects
Key exclusion criteria	Non-heatlhy subjects
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Mizuki Middle name Last name MORITA
Organization	Okayama University
Division name	Graduate School of Interdisciplinary Science and Engineering in Health Systems
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6898
Email	mizuki@okayama-u.ac.jp

Public contact
Name of contact person	1st name Mizuki Middle name Last name MORITA
Organization	Okayama University
Division name	Graduate School of Interdisciplinary Science and Engineering in Health Systems
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6898
Homepage URL
Email	mizuki@okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Okayama University
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	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
Tel	086-235-6938
Email	mae6605@adm.okayama-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	2020 Year 08 Month 12 Day

Related information
URL releasing protocol	-
Publication of results	Unpublished

Result
URL related to results and publications	-
Number of participants that the trial has enrolled	20
Results	As a result of this study, heart rate recovery after 120 seconds (HRR120) in moderate-intensity exercise was obtained as a measure to evaluate exercise tolerance at low intensity and short duration.
Results date posted	2021 Year 11 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Healthy subjects
Participant flow	Notice
Adverse events	None
Outcome measures	Decay of heart rate after the end of exercise
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 07 Month 28 Day
Date of IRB	2020 Year 10 Month 01 Day
Anticipated trial start date	2020 Year 09 Month 29 Day
Last follow-up date	2020 Year 11 Month 02 Day
Date of closure to data entry	2020 Year 11 Month 02 Day
Date trial data considered complete	2020 Year 12 Month 15 Day
Date analysis concluded	2020 Year 12 Month 24 Day

Other
Other related information

Management information
Registered date	2020 Year 08 Month 12 Day
Last modified on	2021 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047222