UMIN-CTR Clinical Trial

Basic information
Public title	The effects of low intensity treadmill walking in water on stress indices
Acronym	The effects of low intensity treadmill walking in water on stress indices
Scientific Title	The effects of low intensity treadmill walking in water on stress indices
Scientific Title:Acronym	The effects of low intensity treadmill walking in water on stress indices
Region	Japan

Condition
Condition	Healthy adult males
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of low intensity treadmill walking in water on stress indices
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Salivary amylase concentration
Key secondary outcomes	cardiac parasympathetic nervous activity, stress related questionnaire (POMS)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	measurement of stress indices > low intensity treadmill walking in water > measurement of stress indices
Interventions/Control_2	measurement of stress indices > standing position in water > measurement of stress indices
Interventions/Control_3	measurement of stress indices > low intensity treadmill walking on land > measurement of stress indices
Interventions/Control_4	measurement of stress indices > standing position on land > measurement of stress indices
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	30 years-old >=
Gender	Male
Key inclusion criteria	Healthy males who have given written informed consent
Key exclusion criteria	Someone fulfilled the criteria as below; 1) females, 2) with motor disorder, 3) with a history of cardiovascular disease, 4) abnormal ECG, 5) smokers, 6) under medication, 7) with latex allergy
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Kumiko Middle name Last name ONO
Organization	Kobe university
Division name	Graduate School of Health Sciences
Zip code	654-0142
Address	7-10-2 Tomogaoka, Suma-ku, Kobe-shi, Hyogo
TEL	078-792-2555
Email	onoku@tiger.kobe-u.ac.jp

Public contact
Name of contact person	1st name Kumiko Middle name Last name ONO
Organization	Kobe university
Division name	Graduate School of Health Sciences
Zip code	654-0142
Address	7-10-2 Tomogaoka, Suma-ku, Kobe-shi, Hyogo
TEL	078-792-2555
Homepage URL
Email	onoku@tiger.kobe-u.ac.jp

Sponsor
Institute	Kobe university
Institute
Department

Funding Source
Organization	Kobe university
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	Kobe University Graduate School of Health Sciences, Health Sciences Ethical Committee
Address	7-10-2 Tomogaoka, Suma, Kobe-shi, Hyogo
Tel	078-792-2555
Email	syomu2@ams.kobe-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

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 21 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	7
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	Completed
Date of protocol fixation	2018 Year 06 Month 04 Day
Date of IRB	2018 Year 08 Month 31 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2019 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	2018 Year 08 Month 20 Day
Last modified on	2019 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038577