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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name