UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033476
Receipt number R000038172
Scientific Title Effect of resistance exercise on hormonal responses in hypoxia
Date of disclosure of the study information 2018/07/24
Last modified on 2018/07/23 14:11:47

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Basic information

Public title

Effect of resistance exercise on hormonal responses in hypoxia

Acronym

Effect of resistance exercise on hormonal responses in hypoxia

Scientific Title

Effect of resistance exercise on hormonal responses in hypoxia

Scientific Title:Acronym

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

1st name
Middle name
Last name Katsuhiro Koyama

Organization

University of Yamanashi

Division name

Graduate School Department of Interdisciplinary Research

Zip code


Address

4-4-37 Takeda, Kofu, Yamanashi, Japan

TEL

055-220-8202

Email

koyama@yamanashi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuhiro Koyama

Organization

University of Yamanashi

Division name

Graduate School Department of Interdisciplinary Research

Zip code


Address

4-4-37 Takeda, Kofu, Yamanashi, Japan

TEL

055-220-8202

Homepage URL


Email

koyama@yamanashi.ac.jp


Sponsor or person

Institute

University of Yamanashi

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Completed

Date of protocol fixation

2015 Year 11 Month 18 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038172