UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036945 |
|---|---|
| Receipt number | 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 22:21:59 |
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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
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/
linoby@uitm.edu.my
Sponsor or person
Institute
Faculty of Sports Science and Recreation, Universiti Teknologi MARA
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042098
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
