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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025661
Receipt No. 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 2020/07/19

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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
Email 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
Email pt.shoji@hospk.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine, Kohnodai Hospital
Institute
Department

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
Email 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 No longer recruiting
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

Other
Other related information

Management information
Registered date
2017 Year 01 Month 13 Day
Last modified on
2020 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029515

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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