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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036945
Receipt No. R000042098
Scientific Title Assessment of feasibility and validation of color-coded system to measure exercise intensity heart rate
Date of disclosure of the study information 2019/06/03
Last modified on 2019/06/03

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Basic information
Public title Assessment of feasibility and validation of color-coded system to measure exercise intensity heart rate
Acronym Assessment of feasibility and validation of color-coded system to measure exercise intensity heart rate
Scientific Title Assessment of feasibility and validation of color-coded system to measure exercise intensity heart rate
Scientific Title:Acronym Assessment of feasibility and validation of color-coded system to measure exercise intensity heart rate
Region
Asia(except Japan)

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

Objectives
Narrative objectives1 to assess feasibility and validate the accuracy of the color-coded system for measuring heart rate in exercising subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Data accuracy of the prototype system (compare to reference device)

(2) Usability and feasibility of the prototype system
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Exercise
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
60 years-old >
Gender Male and Female
Key inclusion criteria (1) Healthy adults

(2) Non-smoker

(3) No contraindication to high intensity exercise

(4) Pass the The Physical Activity Readiness Questionnaire (PAR-Q)
Key exclusion criteria (1) persons who have any dietary supplements, quasi drugs or medicines

(2) persons who have changed their habits to take supplements within past 4 weeks.

(3) Persons who work in night shift or in day and night shift

(4) persons who have been treated their illness or prevention in a clinic

(5) clinical population of any sort of serious diseases

(6) persons with the medical histories of alcoholism or drug dependence

(7) persons who have contraindication with exercise and heart/vascular related problem

(8) persons who are pregnant or breastfeeding at the time of trial
Target sample size 7

Research contact person
Name of lead principal investigator
1st name Adam
Middle name
Last name Linoby
Organization Universiti Teknologi MARA
Division name Faculty of Sports Science and Recreation
Zip code 70300
Address UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremban, Negeri Sembilan, Malaysia
TEL +60133632005
Email linoby@uitm.edu.my

Public contact
Name of contact person
1st name Adam
Middle name
Last name Linoby
Organization Universiti Teknologi MARA
Division name Faculty of Sports Science and Recreation
Zip code 70300
Address UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremban, Negeri
TEL +60133632005
Homepage URL https://seremban.uitm.edu.my/
Email linoby@uitm.edu.my

Sponsor
Institute Faculty of Sports Science and Recreation, Universiti Teknologi MARA
Institute
Department

Funding Source
Organization Fundamental Research Grant Scheme, Ministry of Higher Education (Malaysia)
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Universiti Teknologi MARA (UiTM) Cawangan Negeri Sembilan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Sports Science and Recreation, Universiti Teknologi MARA
Address UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremban, Negeri Sembilan, Malaysia
Tel +606-6342409
Email shari0971@uitm.edu.my

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
2019 Year 06 Month 03 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 7
Results
Results date posted
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

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 03 Month 01 Day
Date of IRB
2018 Year 02 Month 04 Day
Anticipated trial start date
2019 Year 06 Month 03 Day
Last follow-up date
2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 03 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042098

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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