UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048771
Receipt number R000055563
Scientific Title Effect of open water swimming trainig for pool swimmers
Date of disclosure of the study information 2023/04/01
Last modified on 2023/06/29 12:27:18

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Basic information

Public title

Effect of open water swimming trainig for pool swimmers

Acronym

Effect of open water swimming trainig for pool swimmers

Scientific Title

Effect of open water swimming trainig for pool swimmers

Scientific Title:Acronym

Effect of open water swimming trainig for pool swimmers

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine effect of open water swimming training for pool swimmers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

OBLA, Lactate threshold, results of open water swimming, 1500m swimming time

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

opwn water swimming trainig

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

18 years-old <=

Age-upper limit

23 years-old >

Gender

Male

Key inclusion criteria

Swimmers can do open water swimming and pool training

Key exclusion criteria

Individuals who have difficulty in exercising due to surgical or medical disorders.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name Reira
Middle name
Last name Hara

Organization

Nihon university

Division name

College of sports sciences

Zip code

1540002

Address

3-34-1, shimouma, setagaya-ku, Tokyo

TEL

03-6453-1700

Email

hara.reira@nihon-u.ac.jp


Public contact

Name of contact person

1st name Reira
Middle name
Last name Hara

Organization

Nihon university

Division name

College of sports sciences

Zip code

1540002

Address

3-34-1, shimouma, setagaya-ku, Tokyo

TEL

03-6453-1700

Homepage URL


Email

hara.reira@nihon-u.ac.jp


Sponsor or person

Institute

Nihon university

Institute

Department

Personal name



Funding Source

Organization

Nothing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nihon University

Address

3-34-1, shimouma, setagaya-ku, Tokyo

Tel

03-6453-1700

Email

rmss.kenkyu@nihon-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

日本大学


Other administrative information

Date of disclosure of the study information

2023 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

4

Results

Time of 1500m freestyle and OBLA were improved in 3 athletes. vLT was improved in 2 athletes. It hasn't been revealed how those physiological changes effect on 1500m freestyle. Open water swimming training might be made lower their resistance to swimming distance and they can swim high swimming velocity in beginning or end of 1500m races.

Results date posted

2023 Year 06 Month 29 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 04 Month 04 Day

Baseline Characteristics

Four collegiate competitive long-distance swimmers

Participant flow

The purpose and content of the study, as well as the anonymity of personal information and survey results, were fully explained orally to each subject. After informed consent was given, written consent was obtained from the subjects to voluntarily participate in the study.

Adverse events

Nothing

Outcome measures

Training details, swimming 1500m freestyle record, OBLA, lactate threshold.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2022 Year 10 Month 01 Day

Date of IRB

2022 Year 09 Month 07 Day

Anticipated trial start date

2022 Year 09 Month 07 Day

Last follow-up date

2022 Year 09 Month 10 Day

Date of closure to data entry

2022 Year 09 Month 27 Day

Date trial data considered complete

2022 Year 10 Month 10 Day

Date analysis concluded

2023 Year 04 Month 04 Day


Other

Other related information

Nothing


Management information

Registered date

2022 Year 08 Month 26 Day

Last modified on

2023 Year 06 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055563


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name