UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053229 |
|---|---|
| Receipt number | R000060743 |
| Scientific Title | Testing the intervention effects of ergometer exercises of different intensities on muscle characteristics, muscle function, and cardiopulmonary function |
| Date of disclosure of the study information | 2023/12/26 |
| Last modified on | 2024/03/15 14:13:30 |
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Basic information
Public title
Testing the intervention effects of ergometer exercises of different intensities on muscle characteristics, muscle function, and cardiopulmonary function
Acronym
Effects of ergometer exercise at different intensities on muscle and cardiorespiratory function
Scientific Title
Testing the intervention effects of ergometer exercises of different intensities on muscle characteristics, muscle function, and cardiopulmonary function
Scientific Title:Acronym
Effects of ergometer exercise at different intensities on muscle characteristics, muscle function, and cardiopulmonary function
Region
| Japan |
Condition
Condition
Healthy men and women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify the effects of low-intensity, high-intensity, and interval conditions of ergometer exercise on muscle characteristics, muscle function, and cardiopulmonary function by controlling the amount of training load.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to identify the relationship between muscle swelling immediately after ergometer exercise at different intensities and the effect of muscle hypertrophy after 8 weeks of training intervention.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
1)Change of muscle quality before and after intervention
2)Change of cardiopulmonary function before and after intervention
Key secondary outcomes
1)Maximum voluntary isometric contraction
2)Maximum voluntary isokinetic contraction
3)Maximum Load Intensity(W)
4)Change of muscle thickness before and after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Low-intensity ergometer exercise
Interventions/Control_2
High-intensity ergometer exercise
Interventions/Control_3
Ergometer exercise with interval conditions
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy men and women who understand the explanation of the study and the instruction of the exercise.
Key exclusion criteria
1)Subjects with a history of orthopedic or neurological disease in their limbs
2)Subjects with exercise habits who train on a daily basis
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Ichihashi |
Organization
Kyoto University
Division name
Human Health Science, Graduate School of Medicine
Zip code
606-8507
Address
53, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3951
ichihashi.noriaki.5z@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Hirozawa |
Organization
Kyoto University
Division name
Human Health Science, Graduate School of Medicine
Zip code
606-8507
Address
53, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
080-9343-7319
Homepage URL
hirozawa.kohei.44v@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University, Human Health Science, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University, Human Health Science, Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Society for the Promotion of Science
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
京都大学大学院(京都府)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060743
| Research Plan | |
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| 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 |
