UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of resistance exercise on hormonal responses in hypoxia
Title of the study (Brief title)	Effect of resistance exercise on hormonal responses in hypoxia
Region	Japan

Condition
Condition	Healthy individuals
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examined the effect of resistance exercise on hormonal responses in hypoxia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Growth hormone concentrations (post-exercise)
Key secondary outcomes	irisin, Meteorin-like (Metrnl), blood pressure, heart rate, SpO2, ADH, aldosterone, hANP, adenosine, OSM, FFA

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Single bout of resistance exercise under hypoxic condition (FiO2 = 0.13)
Interventions/Control_2	Single bout of resistance exercise under normoxic condition
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. Subjects engaged in regular physical activity (1 -2 h per day, 3-5 days per week). 2. Non-smokers 3. No prior history of cardiovascular diseases
Key exclusion criteria	None of the subjects had been exposed to an altitude higher than 1500 m within six month prior to the study.
Target sample size	8

Research contact person
Name of lead principal investigator	Katsuhiro Koyama
Organization	University of Yamanashi
Division name	Graduate School Department of Interdisciplinary Research
Address	4-4-37 Takeda, Kofu, Yamanashi, Japan
TEL	055-220-8202
Email	koyama@yamanashi.ac.jp

Public contact
Name of contact person	Katsuhiro Koyama
Organization	University of Yamanashi
Division name	Graduate School Department of Interdisciplinary Research
Address	4-4-37 Takeda, Kofu, Yamanashi, Japan
TEL	055-220-8202
Homepage URL
Email	koyama@yamanashi.ac.jp

Sponsor
Institute	University of Yamanashi
Institute
Department

Funding Source
Organization	University of Yamanashi
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 07 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 18 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2016 Year 01 Month 15 Day
Date of closure to data entry	2016 Year 01 Month 16 Day
Date trial data considered complete	2016 Year 01 Month 16 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 07 Month 23 Day
Last modified on	2018 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038172