UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047585 |
|---|---|
| Receipt number | R000053384 |
| Scientific Title | Acute response of myokine and osteokine after exercise |
| Date of disclosure of the study information | 2022/04/25 |
| Last modified on | 2026/04/28 09:12:22 |
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Basic information
Public title
The association of myokine and osteokine
Acronym
The association of myokine and osteokine
Scientific Title
Acute response of myokine and osteokine after exercise
Scientific Title:Acronym
Acute response of myokine and osteokine after exercise
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the responses after two kinds of exercise of different mechanical load.
Basic objectives2
Others
Basic objectives -Others
To evaluate the associations of myokines and osteokines
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in myokine and osteokine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Aerobic exercise by ergometer
30 minutes, single time
Interventions/Control_2
Aerobic exercise by ergometer combined with electrical stimulation
30 minutes, single time
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 20 years old or older.
2) does not have the regular exercise within the past six months.
Key exclusion criteria
1) Severe heart failure, renal failure, respiratory failure, cerebrovascular disease, and malignant disorder.
2) A chief physician forbids exercise.
3) take medicine affecting fat metabolism now.
4) take medicine affecting bone metabolism now or have taken it until at least a year ago.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | HIROO |
| Middle name | |
| Last name | MATSUSE |
Organization
Kurume University
Division name
Division of rehabilitation
Zip code
8300011
Address
Asahi-machi 67, Kurume, Fukuoka
TEL
0942353311
matsuse_hiroh@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROO |
| Middle name | |
| Last name | MATSUSE |
Organization
Kurume university
Division name
Division of rehabilitation
Zip code
8300011
Address
Asahi-machi 67, Kurume, Fukuoka
TEL
0942353311
Homepage URL
matsuse_hiroh@kurume-u.ac.jp
Sponsor or person
Institute
Kurume Universiy
Institute
Department
Personal name
Funding Source
Organization
KAKENHI Grant
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
Ethics Committee of Kurume University
Address
Asahi-machi 67, Kurume, Fukuoka
Tel
0942353311
i_rinri@kurume-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 25 | 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
Main results already published
Date of protocol fixation
| 2021 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 04 | Month | 25 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053384
