UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054237 |
|---|---|
| Receipt number | R000061926 |
| Scientific Title | Acute effect of bench-step exercise on peripheral blood gene methylation/expression and SPARC in older individuals. |
| Date of disclosure of the study information | 2024/04/25 |
| Last modified on | 2024/04/23 17:20:11 |
* 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
Influence of bench-step exercise on inflammation in older individuals.
Acronym
Bench-step exercise and inflammation
Scientific Title
Acute effect of bench-step exercise on peripheral blood gene methylation/expression and SPARC in older individuals.
Scientific Title:Acronym
Bench-step exercise, blood gene methylation, and SPARC
Region
| Japan |
Condition
Condition
Non-communicable disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to clarify the effects of acute bench-step exercise on inflammatory indices, such as SPARC and PYCARD methylation in older individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum SPARC concentration levels
Key secondary outcomes
peripheral blood PYCARD methylation and peripheral blood OGG1 methylation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
acute exercise
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Older individuals who are free from medical conditions that contraindicated exercise, such as cardiovascular disease or orthopedic disease.
Key exclusion criteria
Older individuals who have medical conditions that contraindicate exercise, such as cardiovascular disease or orthopedic disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Nishida |
Organization
Saga University
Division name
Faculty of Medicine
Zip code
849-8501
Address
Nabeshima 5-1-1, Saga
TEL
0952342287
ynishida@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Nishida |
Organization
Saga University
Division name
Faculty of Medicine
Zip code
849-8501
Address
Nabeshima 5-1-1, Saga
TEL
0952342287
Homepage URL
ynishida@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Mitsui Sumitomo Insurance Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of the Faculty of Medicine, Saga University
Address
Nabeshima 5-1-1, Saga
Tel
0952343357
kenkyu-shinsei@ml.cc.saga-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
| 2024 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
37
Results
The acute bout of moderate bench-step exercise at the anaerobic threshold reduced the serum SPARC levels in older adults. The PYCARD methylation (at the CpG site 3) was inversely correlated with the change in the serum SPARC levels immediately after the exercise.
Results date posted
| 2024 | Year | 04 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
81% of the study participants were women. The mean value of the anaerobic threshold in the older participants was 4.27 METs. The mean values of the serum SPARC concentration levels and the PYCARD DNA methylation levels (average of 7 CpG sites) at rest (before performing the 15-min bench-step exercise) were 531 ng/mL and 0.94%, respectively.
Participant flow
On the first survey day, anthropometric indices and blood pressure were measured, and a graded incremental exercise test was performed using a step bench. On the second survey day, the older participants performed 15-min moderate bench-step exercise at the anaerobic threshold, and blood sampling was performed before and immediately after the exercise.
Adverse events
None
Outcome measures
Serum SPARC levels
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2017 | 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
| 2024 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061926
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
