UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056822
Receipt number R000064727
Scientific Title Investigation of the implementation method of hydrotherapy (cold water immersion) for recovery of post-exercise muscle fatigue
Date of disclosure of the study information 2025/08/01
Last modified on 2025/01/26 23:43:58

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Basic information

Public title

Investigation of the implementation method of hydrotherapy (cold water immersion) for recovery of post-exercise muscle fatigue

Acronym

Investigation of the implementation method of hydrotherapy (cold water immersion) for recovery of post-exercise muscle fatigue

Scientific Title

Investigation of the implementation method of hydrotherapy (cold water immersion) for recovery of post-exercise muscle fatigue

Scientific Title:Acronym

Investigation of the implementation method of hydrotherapy (cold water immersion) for recovery of post-exercise muscle fatigue

Region

Japan


Condition

Condition

College soccer player

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to determine the optimal implementation and effectiveness of cold water immersion.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Performance assessment - 20m-sprint

Key secondary outcomes

Performance assessment - Counter movement jump, Yo-Yo Intermittent Recovery Level 2.
Questionnaire on athletic history, hydrotherapy experience, and sleep evaluation
Urinary metabolites
Evaluation of fatigue and muscle pain (Numerical Rating Scale)
Deep body temperature
Color Word matching Stroop Task
Trail Making Test
Heart rate
Skin surface temperature


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Cold water immersion conditions 1.
10 degrees - 2.5 minutes - immersion up to the height of the anterior superior iliac spine

Interventions/Control_2

Cold water immersion condition 2.
15 degrees - 11 minutes - immersion up to the height of the anterior superior iliac spine

Interventions/Control_3

Control group: No immersion in cold water

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

22 years-old >=

Gender

Male

Key inclusion criteria

(i) Those who have no obvious organic disease.
(ii) A member of a university athletic team and active as a player.

Key exclusion criteria

Participants who were unable to participate in all experimental conditions due to injury or poor health were excluded.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Ryosuke
Middle name
Last name Kaji

Organization

Rikkyo University

Division name

College of Sports and Wellness

Zip code

352-8558

Address

Rikkyo University Niiza Campus, 1-2-26 Kitano, Niiza-shi, Saitama, Japan

TEL

048-471-7549

Email

24sn002k@rikkyo.ac.jp


Public contact

Name of contact person

1st name Ryosuke
Middle name
Last name Kaji

Organization

Rikkyo University

Division name

College of Sports and Wellness

Zip code

352-8558

Address

Rikkyo University Niiza Campus, 1-2-26 Kitano, Niiza-shi, Saitama, Japan

TEL

048-471-7549

Homepage URL


Email

24sn002k@rikkyo.ac.jp


Sponsor or person

Institute

Rikkyo University

Institute

Department

Personal name

Ryosuke Kaji


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

Rikkyo University Niiza Campus, 1-2-26 Kitano, Niiza-shi, Saitama, Japan

Tel

048-471-7549

Email

24sn002k@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

追手門学院大学 茨木安威キャンパス(大阪府)


Other administrative information

Date of disclosure of the study information

2025 Year 08 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

2024 Year 11 Month 06 Day

Date of IRB

2024 Year 11 Month 06 Day

Anticipated trial start date

2024 Year 11 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

2025 Year 01 Month 26 Day

Last modified on

2025 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064727