UMIN-CTR 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 | 2025/01/11 09:29:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
kohei246231@gmail.com
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
42
Results
All 42 participants trained three times per week for eight weeks. Results from a long-term intervention of cycle ergometer training at different intensities with matched total volume revealed comparable muscle hypertrophy effects were obtained regardless of different training intensities. Moreover, improvements in muscle quality appeared to be more pronounced with higher-intensity training. Endurance-enhancing effects were found to be greater with interval and high-intensity training.
Results date posted
| 2025 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy men and women aged 18 to 40 years
Participant flow
The participants were informed about the study in advance and their consent for participation and signatures were obtained. Afterwards, they were randomly assigned to the low-intensity, interval, or high-intensity group and underwent training three times per week for eight weeks.
Adverse events
None
Outcome measures
Results are shown as mean(standard deviation)[95% confidence interval].
1)Change of muscle quality(a.u.)
Low-intensity group: from 59.4(8.4) to 59.3(8.9)[-1.17,1.27], Interval group: from 61.9(9.7) to 61.1(9.8)[-0.54,2.22], High-intensity group: from 62.3(10.4) to 60.9(10.9)[0.32,2.38]
2)Change of muscle thickness(cm)
Low-intensity group: from 17.3(1.9) to 17.6(2.0)[-0.54,-0.09], Interval group: from 18.2(2.8) to 18.7(2.8)[-0.82,-0.11], High-intensity group: from 16.8(2.3) to 17.3(2.3)[-0.78,-0.28]
3)Change of cardiopulmonary function
3-1.The participant's maximum power output in watts(W)
Low-intensity group: from 162.0(31.1) to 177.3(32.9)[-20.26,-10.31], Interval group: from 181.4(34.4) to 199.0(37.7)[-22.30,-12.98], High-intensity group: from 181.3(38.6) to 207.5(41.5)[-30.96,-21.47]
3-2.Maximum oxygen uptake(ml/kg/min)
Low-intensity group: from 29.3(7.6) to 29.4(7.4)[-1.52,1.50], Interval group: from 32.5(5.0) to 33.6(4.8)[-1.96,-0.17], High-intensity group: from 32.8(5.9) to 32.8(5.1)[-4.14,-1.80]
4)Maximum voluntary isometric contraction(Nm/kg)
Low-intensity group: from 2.58(0.68) to 2.78(0.57)[-0.38,0.00], Interval group: from 2.81(0.45) to 2.97(0.43)[-0.34,0.01], High-intensity group: from 2.81(0.58) to 3.12(0.65)[-0.52,-0.09]
5)Maximum voluntary isokinetic contraction(Nm/kg)
5-1.60 deg/s
Low-intensity group: from 2.11(0.70) to 2.41(0.52)[-0.51,-0.09], Interval group: from 2.30(0.41) to 2.52(0.40)[-0.46,0.03], High-intensity group: from 2.37(0.56) to 2.61(0.51)[-0.45,-0.03]
5-2.180 deg/s
Low-intensity group: from 1.54(0.51) to 1.61(0.47)[-0.22,0.07], Interval group: from 1.50(0.39) to 1.63(0.39)[-0.30,0.05], High-intensity group: from 1.67(0.34) to 1.83(0.28)[-0.30,0.00]
5-3.300 deg/s
Low-intensity group: from 1.13(0.45) to 1.14(0.38)[-0.10,0.09], Interval group: from 1.11(0.23) to 1.20(0.23)[-0.20,0.01], High-intensity group: from 1.25(0.30) to 1.38(0.22)[-0.25,0.01]
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
| 2024 | Year | 11 | Month | 15 | Day |
Date trial data considered complete
| 2024 | Year | 11 | Month | 20 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 26 | Day |
Last modified on
| 2025 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060743
