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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000042190
Receipt No. 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

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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
Email 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
Email yokoyama@sports.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048152

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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