UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048409 |
|---|---|
| Receipt number | R000055127 |
| Scientific Title | Effect of the upper limb muscular conditioning on the outcome of cardiopulmonary exercise test using arm-crank ergometer |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2024/01/20 11:19:38 |
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Basic information
Public title
Effect of the upper limb muscular conditioning on the outcome of cardiopulmonary exercise test using arm-crank ergometer
Acronym
Effect of the upper limb muscular conditioning on the outcome of cardiopulmonary exercise test using arm-crank ergometer
Scientific Title
Effect of the upper limb muscular conditioning on the outcome of cardiopulmonary exercise test using arm-crank ergometer
Scientific Title:Acronym
Effect of the upper limb muscular conditioning on the outcome of cardiopulmonary exercise test using arm-crank ergometer
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the upper limb muscular conditioning on the outcome of cardiopulmonary exercise test using arm-crank ergometer
Basic objectives2
Others
Basic objectives -Others
Verification of applicability of exercise test using arm-crank ergometer
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Regression of oxygen uptake on heart rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Exercise test using an arm-crank ergometer
Interventions/Control_2
Exercise test using a bicycle ergometer
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults exercising on a daily basis
Key exclusion criteria
Person who is judged by a medical doctor as not eligible for exercise
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
0666052947
yokoyama_hisayo@omu.ac.jp
Public contact
Name of contact person
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
0666052947
Homepage URL
yokoyama_hisayo@omu.ac.jp
Sponsor or person
Institute
Environmental Physiology for Exercise, Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional Review Board of Osaka Metropolitan University Graduate School of Medicine
Address
1-2-7-601, Asahi-Machi, Abeno-ku, Osaka
Tel
0666453456
gr-a-knky-ethics@omu.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
| 2022 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2076-3417/13/23/12926
Number of participants that the trial has enrolled
17
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 03 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 07 | Month | 20 | Day |
Last modified on
| 2024 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055127
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
