UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042190 |
|---|---|
| Receipt number | R000048152 |
| Scientific Title | Estimation of energy expenditure of para-athletes from the results of cardiopulmonary exercise test using arm-crank ergometer and heart rate monitoring |
| Date of disclosure of the study information | 2020/10/21 |
| Last modified on | 2020/10/21 15:27:06 |
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Basic information
Public title
Estimation of energy expenditure of para-athletes from the results of cardiopulmonary exercise test using arm-crank ergometer and heart rate monitoring
Acronym
Estimation of energy expenditure of para-athletes from the results of cardiopulmonary exercise test using arm-crank ergometer and heart rate monitoring
Scientific Title
Estimation of energy expenditure of para-athletes from the results of cardiopulmonary exercise test using arm-crank ergometer and heart rate monitoring
Scientific Title:Acronym
Estimation of energy expenditure of para-athletes from the results of cardiopulmonary exercise test using arm-crank ergometer and heart rate monitoring
Region
| Japan |
Condition
Condition
Physically handicapped (spinal cord injury, lower limb defect/amputation, etc)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how to estimate energy expenditure of para-athletes from the results of cardiopulmonary exercise test using arm-crank ergometer and heart rate monitoring
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between heart rate and oxygen consumption rate
Key secondary outcomes
energy expenditure (active/inactive day)
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 test
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Athletes with physical disabilities such as spinal cord injury or lower limb defect/amputation belonging to a sports organization for people with disabilities based in Osaka Prefecture
Key exclusion criteria
Athletes with visual, hearing or intellectual impairment or with other medical disease/Athletes who are judged by the investigator to be difficult or ineligible to exercise in advance
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
+81666052947
yokoyama@sports.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
+81666052947
Homepage URL
yokoyama@sports.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University, medical research ethics committee
Address
1-2-7-601, Asahi-Machi, Abeno-ku, Osaka
Tel
0666453456
ethics@med.osaka-cu.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
大阪市立大学都市健康・スポーツ研究センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 21 | 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
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
Terminated
Date of protocol fixation
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 21 | Day |
Last modified on
| 2020 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048152
| 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 |
