UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000054432
Receipt number R000062170
Scientific Title Comprehensive Analysis of Athlete Urine Samples for the Development of New Muscle Fatigue Indicators phase 2
Date of disclosure of the study information 2024/05/20
Last modified on 2024/05/19 20:19:15

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Basic information

Public title

Comprehensive Analysis of Athlete Urine Samples for the Development of New Muscle Fatigue Indicators phase 2

Acronym

Comprehensive Analysis of Athlete Urine Samples for the Development of New Muscle Fatigue Indicators phase 2

Scientific Title

Comprehensive Analysis of Athlete Urine Samples for the Development of New Muscle Fatigue Indicators phase 2

Scientific Title:Acronym

Comprehensive Analysis of Athlete Urine Samples for the Development of New Muscle Fatigue Indicators phase 2

Region

Japan


Condition

Condition

Muscle Fatigue

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It aims to understand the impact of massage on muscle fatigue recovery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

urinary metabolite

Key secondary outcomes

Subjective fatigue
Quadriceps and hamstring stretch pain


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Massage

Interventions/Control_2

Control

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

18 years-old <=

Age-upper limit

25 years-old >=

Gender

Male

Key inclusion criteria

(1) University athletes who belong to the Rikkyo University Athletic Association and are active as athletes.
(2) Those who agree not to be compensated for any events related to this research.

Key exclusion criteria

Individuals who did not give consent for the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name NARUTO
Middle name
Last name YOSHIDA

Organization

Rikkyo University

Division name

College of Sport and Wellness

Zip code

352-8558

Address

1-2-26 Kitano, Niiza-shi, Saitama, Japan

TEL

048-471-7549

Email

naruto-y-ad@rikkyo.ac.jp


Public contact

Name of contact person

1st name NARUTO
Middle name
Last name YOSHIDA

Organization

Rikkyo University

Division name

College of Sport and Wellness

Zip code

352-8558

Address

1-2-26 Kitano, Niiza-shi, Saitama, Japan

TEL

048-471-7549

Homepage URL


Email

naruto-y-ad@rikkyo.ac.jp


Sponsor or person

Institute

RIkkyo University

Institute

Department

Personal name

NARUTO YOSHIDA


Funding Source

Organization

Rikkyo 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

Rikkyo University

Address

1-2-26 Kitano, Niiza-shi, Saitama, Japan

Tel

048-471-7549

Email

naruto-y-ad@rikkyo.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

2024 Year 05 Month 20 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

2024 Year 04 Month 01 Day

Date of IRB

2024 Year 05 Month 10 Day

Anticipated trial start date

2024 Year 05 Month 20 Day

Last follow-up date

2025 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

2024 Year 05 Month 18 Day

Last modified on

2024 Year 05 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062170