UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057552 |
|---|---|
| Receipt number | R000065738 |
| Scientific Title | The effects of different exercise postures during cardiopulmonary exercise testing on exercise tolerance indices and physical and mental functions: Comparison between upright and recumbent ergometers |
| Date of disclosure of the study information | 2025/04/08 |
| Last modified on | 2026/04/17 08:46:21 |
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Basic information
Public title
The effects of different exercise postures during cardiopulmonary exercise testing on exercise tolerance indices and physical and mental functions: Comparison between upright and recumbent ergometers
Acronym
The effects of different ergometers on physical and mental functions during cardiopulmonary exercise testing
Scientific Title
The effects of different exercise postures during cardiopulmonary exercise testing on exercise tolerance indices and physical and mental functions: Comparison between upright and recumbent ergometers
Scientific Title:Acronym
The effects of different ergometers on physical and mental functions during cardiopulmonary exercise testing
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Cardiology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether an upright ergometer and a recumbent ergometer produce similar exercise effects during cardiopulmonary exercise testing, and to clarify the significance of selecting an ergometer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oxygen uptake, heart rate, and load at anaerobic threshold on two types of ergometers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform cardiopulmonary exercise testing using an upright ergometer
Interventions/Control_2
Perform cardiopulmonary exercise stress testing using a recumbent 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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adults
Key exclusion criteria
Those with exercise habits
Smokers
Those with resting systolic blood pressure of 180mmHg or more or less than 80mmHg
Those whose R is already greater than 1 when CPX is started
Those who reach a peak before reaching AT
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | nishimoto |
Organization
Kawashima Hospital
Division name
Rehabilitation Technology Department
Zip code
770-0011
Address
6-1 Kitasakoichibancho, Tokushima City, Tokushima Prefecture
TEL
088-631-0110
reha-nishimoto@khg.or.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Nishimoto |
Organization
Kawashima Hospital
Division name
Rehabilitation Technology Department
Zip code
770-0011
Address
6-1 Kitasakoichibancho, Tokushima City, Tokushima Prefecture
TEL
088-631-0110
Homepage URL
reha-nishimoto@khg.or.jp
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawashima Hospital Ethics Review Committee
Address
6-1 Kitasakoichibancho, Tokushima City, Tokushima Prefecture
Tel
088-631-0110
reha-nishimoto@khg.or.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
| 2025 | Year | 04 | Month | 08 | 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
10
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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 04 | Month | 08 | Day |
Last modified on
| 2026 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065738
