UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029090
Receipt number R000033269
Scientific Title The relationship between the degree of difficulty of the antagonistic exercises and prefrontal cerebral blood flow
Date of disclosure of the study information 2017/09/15
Last modified on 2022/03/15 17:12:44

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Basic information

Public title

The relationship between the degree of difficulty of the antagonistic exercises and prefrontal cerebral blood flow

Acronym

The relationship between the degree of difficulty of the antagonistic exercises and prefrontal cerebral blood flow

Scientific Title

The relationship between the degree of difficulty of the antagonistic exercises and prefrontal cerebral blood flow

Scientific Title:Acronym

The relationship between the degree of difficulty of the antagonistic exercises and prefrontal cerebral blood flow

Region

Japan


Condition

Condition

healthy subject

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The first purpose is to determine the degree of difficulty of the antagonistic exercises
The second purpose is determine a difference of the prefrontal cerebral blood flow of subjects during each tasks

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the number of the errors

Key secondary outcomes

prefrontal cerebral blood flow
Subjective degree of difficulty (Visual Analog Scale)


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

Other

Interventions/Control_1

antagonistic 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

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Person with the exercise capacity that can conduct a problem
Age is a person 20 years or older at the person agreement acquisition with the exercise capacity that can conduct a problem
The person that the agreement of the study was obtained

Key exclusion criteria

A person with a history of the disease of the central nerve disorder
The person whom a study person in charge judged to be inadequate as subjects

Target sample size

27


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Sagari

Organization

Shinshu University

Division name

Division of Occupational Therapy School of Health Science

Zip code

3900821

Address

3-1-1 asahi matsumoto nagano japan

TEL

0263-37-2404

Email

sagaria@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Akira
Middle name
Last name Sagari

Organization

Shinshu University

Division name

Division of Occupational Therapy School of Health Science

Zip code

3900821

Address

3-1-1 asahi matsumoto nagano japan

TEL

0263-37-2404

Homepage URL


Email

sagaria@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Shinshu University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shinshu University School of Medicine Ethics Review Board

Address

3-1-1 asahi matsumoto nagano japan

Tel

0263372572

Email

mdrinri@shinshu-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

2017 Year 09 Month 15 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000033269

Publication of results

Published


Result

URL related to results and publications

https://www.frontiersin.org/articles/10.3389/fnhum.2020.568030/full

Number of participants that the trial has enrolled

18

Results

The increase in OxyHb was higher in the complex antagonist conditions than in the non-antagonistic and simple antagonistic conditions. There were no differences between the upper limb and upper- and lower-limb conditions. There were no significant difference between the upper limb and upper- and lower-limb conditions in terms of error count. The number of errors was higher in the complex antagonistic than in the non-antagonistic and simple antagonistic conditions.

Results date posted

2022 Year 03 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

13 healthy adults
2 males, 11 females
Average age was 21.4 years.

Participant flow

Eighteen participants took part in the experiment. Five of them were excluded because they showed inappropriate behaviour during the experiment that affected cerebral haemodynamics (drowsiness during the experiment, speech, laughter).

Adverse events

None.

Outcome measures

Non antagonistic task using the upper limbs
VAS score 4
Number of errors 0
Prefrontal cortex 0.02

Non antagonistic task using the upper and lower limbs
VAS score  15
Number of errors 0
Prefrontal cortex 0.06

Simple antagonistic task using the upper limbs
VAS score  13
Number of errors 0
Prefrontal cortex 0.01

Simple antagonistic task using the upper and lower limbs
VAS score  28
Number of errors 0
Prefrontal cortex 0.01

Complex
antagonistic task using the upper limbs
VAS score 61
Number of errors 3
Prefrontal cortex 0.18

Complex
antagonistic task using the upper and lower limbs
VAS score 80
Number of errors 1
Prefrontal cortex 0.15

Data of VAS score and number of errors are presented as the median. Data of prefrontal cortex Oxy-Hb concentration changes are presented as the mean. VAS, visual analog scale; Oxy-Hb, oxygenated hemoglobin.



Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 09 Month 15 Day

Date of IRB

2017 Year 09 Month 04 Day

Anticipated trial start date

2017 Year 09 Month 15 Day

Last follow-up date

2020 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

2017 Year 09 Month 11 Day

Last modified on

2022 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033269


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name