UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025661 |
|---|---|
| Receipt number | R000029515 |
| Scientific Title | Effects of low-intensity resistance training with slow movement and tonic force generation on glycemic variability in healthy individuals |
| Date of disclosure of the study information | 2017/02/13 |
| Last modified on | 2021/07/17 09:24:01 |
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Basic information
Public title
Effects of low-intensity resistance training with slow movement and tonic force generation on glycemic variability in healthy individuals
Acronym
Effects of low-intensity resistance training with slow movement and tonic force generation on glycemic variability in healthy individuals
Scientific Title
Effects of low-intensity resistance training with slow movement and tonic force generation on glycemic variability in healthy individuals
Scientific Title:Acronym
Effects of low-intensity resistance training with slow movement and tonic force generation on glycemic variability in healthy individuals
Region
| Japan |
Condition
Condition
glucose metabolism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of LST on glycemic variety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Glycemic variety evaluated by continuous glucose monitoring system.
Mean glucose levels, SD, MAGE, 24 h area under the glucose curve (AUC), time in hypoglycemia and time in hyperglycemia.
Key secondary outcomes
Physical activity measured by tri-axial accelerometer.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Low-intensity resistance training with slow movement and tonic force generation.
Ten times in 3 sets of leg extension, leg flexion, and bench press.
Interventions/Control_2
To measure glucose concentrations using CGMS.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy individuals with written informed consent to participate in the study.
Key exclusion criteria
Subjects with physical disability for performing resistance training.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Takuro |
Organization
National Center for Global Health and Medicine Kohnodai Hospital
Division name
Department of rehabilitation
Zip code
2728516
Address
1-7-1, Kohnodai, Ichikawa, Chiba
TEL
0473723501
pt.shoji@hospk.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Takuro |
Organization
National Center for Global Health and Medicine Kohnodai Hospital
Division name
Department of rehabilitation
Zip code
2728516
Address
1-7-1, Kohnodai, Ichikawa, Chiba
TEL
0473723501
Homepage URL
pt.shoji@hospk.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine, Kohnodai Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine, Kohnodai Hospital
Address
1-7-1, Kohnodai, Ichikawa, Chiba
Tel
0473723501
pt.shoji@hospk.ncgm.go.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
| 2017 | Year | 02 | Month | 13 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000029515
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000029515
Number of participants that the trial has enrolled
20
Results
The Standard deviations of blood glucose levels were significantly decreased in the LST group one hour after the intervention. Conversely, the M-value was significantly increased in the control group around the same time. However, there were no differences in total physical activity and daily glycemic control between groups.
Results date posted
| 2020 | Year | 07 | Month | 19 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Reviewing.
Date of the first journal publication of results
Baseline Characteristics
We recruited twenty healthy subjects in their 20s to 30s between 20 and 40 years of age who consented to the disclosure of their health examination results. We excluded subjects with diabetes and physical disabilitiesy such as cardiovascular disease, infectious disease, and musculoskeletal disorders.
Participant flow
Adverse events
None.
Outcome measures
We evaluated clinical parameters including fasting glucose levels, 1 h glucose levels at 1 and 2 h after the 75 g oral glucose tolerance test, 2 h glucose levels after the 75 g oral glucose tolerance test, 24 h mean glucose levels, standard deviation (SD) values of 24 h glucose levels, time in hyperglycemiahyperglycaemia, time in hypoglycemiahypoglycaemia, time in normoglycaemia, mean amplitude of glucose excurtionexcursion (MAGE), M-value and 24- h area under the glucose curve (AUC).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 04 | Month | 17 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 13 | Day |
Last modified on
| 2021 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029515
