UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035520 |
|---|---|
| Receipt number | R000040468 |
| Scientific Title | Elucidation of effects of chronic exercise on novel peptide hormones to prevent sarcopenia and chronic diseases |
| Date of disclosure of the study information | 2019/01/11 |
| Last modified on | 2024/01/16 10:51:27 |
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Basic information
Public title
Elucidation of effects of chronic exercise on novel peptide hormones to prevent sarcopenia and chronic diseases
Acronym
Elucidation of effects of chronic exercise on novel peptide hormones to prevent sarcopenia and chronic diseases
Scientific Title
Elucidation of effects of chronic exercise on novel peptide hormones to prevent sarcopenia and chronic diseases
Scientific Title:Acronym
Elucidation of effects of chronic exercise on novel peptide hormones to prevent sarcopenia and chronic diseases
Region
| Japan |
Condition
Condition
Young and Middle-aged and older adults including of obese adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate whether chronic exercise modulates circulating peptide hormone levels to prevent sarcopenia and chronic diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of chronic exercise on circulating peptide hormone levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
6
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Young subjects undertook a chronic aerobic exercise using cycle ergometer. The aerobic exercise-training program consisted of cycling on a leg ergometer for 45-55 min, 60-70% of maximal oxygen uptake, 3 days/week, for 8-12 weeks.
Interventions/Control_2
Middle-aged and older subjects undertook a chronic aerobic exercise using cycle ergometer. The aerobic exercise-training program consisted of cycling on a leg ergometer for 45-55 min, 60-70% of maximal oxygen uptake, 3 days/week, for 8-12 weeks.
Interventions/Control_3
Young subjects undertook a chronic resistance exercise. The resistance exercise-training program to whole body consisted for 10 repetitions, 3 sets, 60-70% of repetition maximum, 3 days/week, for 8-12 weeks.
Interventions/Control_4
Middle-aged and older subjects undertook a chronic resistance exercise. The resistance exercise-training program to whole body consisted for 10 repetitions, 3 sets, 60-70% of repetition maximum, 3 days/week, for 8-12 weeks.
Interventions/Control_5
Non intervention(Young subjects)
Interventions/Control_6
Non intervention(Middle-aged and older subjects)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Subjects who must ban or limit exercise therapy by the doctor
2)Subjects who don't have some therapies and/or medications
3)Subjects who are capable of making a decision by themselves, and provide written consent
Key exclusion criteria
1)Patients with hepatic dysfunction and/or renal dysfunction
2)Patients with cardiovascular diseases
3)Pregnant or plans to become pregnant during the study period
4)Patients with limited exercise therapy
5)Others who judged inappropriate by the examining physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Motoyuki |
| Middle name | |
| Last name | Iemitsu |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Noji-higashi, Kusatsu, Shiga
TEL
077-599-4131
iemitsu@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Motoyuki |
| Middle name | |
| Last name | Iemitsu |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Noji-higashi, Kusatsu, Shiga
TEL
077-599-4131
Homepage URL
iemitsu@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan
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
Ritsumeikan University
Address
1-1-1 Noji-higashi, Kusatsu, Shiga
Tel
077-561-3412
b-rinri@st.ritsumei.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
| 2019 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.aging-us.com/article/102678/text
Publication of results
Unpublished
Result
URL related to results and publications
https://www.aging-us.com/article/102678/text
Number of participants that the trial has enrolled
76
Results
Aerobic training in the young adults reduced arterial stiffness, but circulating salusin-alpha level did not change.
Aerobic training in the middle-aged and older adults reduced arterial stiffness with an increase in circulating salusin-alpha level.
The change in arterial stiffness before and after interventons was associated with circulating salusin-alpha levels.
Results date posted
| 2024 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy 36 young and 40 middle-aged and older adults
Participant flow
This subdivision resulted in the formation of four groups: a Young-Training group, a Young control group, a Middle-aged and older-Training group, and a Middle-aged and older-Con group. In the training groups, subjects underwent eight weeks of aerobic exercise training.
Adverse events
None
Outcome measures
arterial stiffness, circulating salusin level, maximal oxygen uptake
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040468
