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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035918
Receipt No. 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

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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
Institute Shinshu University
Institute
Department

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
URL(English) https://upload.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


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