UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035918
Receipt number R000040920
Scientific Title Verification of blood lactate acid as index of muscle fatigue recovery
Date of disclosure of the study information 2019/04/01
Last modified on 2019/02/18 17:32:32

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Basic information

Public title

Verification of blood lactate acid as index of muscle fatigue recovery

Acronym

Validity of blood lactate acid

Scientific Title

Verification of blood lactate acid as index of muscle fatigue recovery

Scientific Title:Acronym

Validity of blood lactate acid

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, an effective procedure for stretching and citric acid intake, which is used as a method of muscle fatigue restoration, will be studied with the blood lactate value as an index of effect determination.

Basic objectives2

Others

Basic objectives -Others

In this study, an effective procedure for stretching and citric acid intake, which is used as a method of muscle fatigue restoration, will be studied with the blood lactate value as an index of effect determination. As a result of this study, if the effective implementation contents of stretching and citric acid intake are clarified, there is a possibility that in the clinical practice of physical therapy, more appropriate support including not only exercise but also recovery of muscle fatigue by exercise is possible is there.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in blood lactate acid before and after intervention

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food Other

Interventions/Control_1

Presence / absence of stretching,

Interventions/Control_2

timing of ingestion of citric acid

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

50 years-old >

Gender

Male and Female

Key inclusion criteria

1. Adult (both male and female are acceptable). It also covers Shinshu University and hospital officials, students, and those belonging to the medical department.
2. Person who got written consent based on his her free will after receiving sufficient explanation for participation in this research

Key exclusion criteria

1.Person who regularly ingests ascorbic acid, supplement containing L-cysteine.
2. Pregnant women.
3. Person who is administered a biguanite agent.
4. Persons undergoing confirmed diagnosis of lactic acidosis.
5. In addition, patients whose research managers judged inappropriate as subjects

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hitomi Nishizawa

Organization

Shinshu University

Division name

School of Medicine Department of Health Sciences

Zip code


Address

3-1-1 Asahi Matsumoto City, Nagano Prefecture

TEL

0263-37-2414

Email

hitnishi@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitomi Nishizawa

Organization

Shinshu University

Division name

School of Medicine Department of Health Sciences

Zip code


Address

3-1-1 Asahi Matsumoto City, Nagano Prefecture

TEL

0263-37-2414

Homepage URL


Email

hitnishi@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


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

nishiza-748

Org. issuing International ID_1

Shinshu University

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2019 Year 02 Month 04 Day

Date of IRB


Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 02 Month 18 Day

Last modified on

2019 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040920


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name