UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000021155
Receipt number	R000024386
Scientific Title	Development of screening test for acute mountain sickness
Date of disclosure of the study information	2016/05/01
Last modified on	2024/03/04 10:18:43

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Basic information

Public title

Development of screening test for acute mountain sickness

Acronym

Development of screening test for acute mountain sickness

Scientific Title

Development of screening test for acute mountain sickness

Scientific Title:Acronym

Development of screening test for acute mountain sickness

Region

Japan

Condition

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Acute mountain sickness (AMS) is triggered by high altitude hypoxia, and can be fatal. Before climbing to high altitude, if we can distinguish who is more likely to suffer from AMS, it should reduce individuals' risk to develop AMS. Nonetheless, few investigators have succeed in predicting AMS at sea level. In order to develop the screening test for AMS, we attempt to elucidate the relationships between cardiorespiratory responses to exercise under various hypoxic conditions and AMS level during actual climbing to high altitude around 3000m.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Assessment

Primary outcomes

The optimal methods and parameters for screening test for preventing AMS

Key secondary outcomes

The multiple regression equation of AMS score estimated from various parameters

Base

Study type

Interventional

Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Pseudo-randomization

Intervention

No. of arms

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.

Interventions/Control_2

Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.

Interventions/Control_3

Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea -> Exercise with Normoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.

Interventions/Control_4

Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.

Interventions/Control_5

Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea -> Exercise with Acute hypoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.

Interventions/Control_6

Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Isocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.

Interventions/Control_7

Exercise with Gradual hypoxia and Isocapnea -> Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.

Interventions/Control_8

Exercise with Gradual hypoxia and Isocapnea -> Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Acute hypoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.

Interventions/Control_9

Exercise with Gradual hypoxia and Isocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.

Interventions/Control_10

Exercise with Gradual hypoxia and Isocapnea -> Exercise with Acute hypoxia and Poikilocapnea -> Exercise with Normoxia and Poikilocapnea -> Exercise with Gradual hypoxia and Poikilocapnea
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.

Eligibility

Age-lower limit

40 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy middle-aged and elderly adults
those who have climbed high altitude (around or above 3000m) mountains within about two years

Key exclusion criteria

Patients of circulatory or respiratory disease, or those who have limitation of movement (e.g. walking)

Target sample size

Research contact person

Name of lead principal investigator

1st name Koji

Middle name

Last name Ishida

Organization

Nagoya University

Division name

Research Center of Health, Physical Fitness and Sports

Zip code

464-8601

Address

E5-2(130), Furo-cho, Chikusa-ku, Nagoya 464-8601, JAPAN

TEL

052-788-6258

Email

ishida@htc.nagoya-u.ac.jp

Public contact

Name of contact person

1st name Koji

Middle name

Last name Ishida

Organization

Nagoya University

Division name

Research Center of Health, Physical Fitness and Sports

Zip code

464-8601

Address

E5-2(130), Furocho, Chikusaku, Nagoya 464-8601, JAPAN

TEL

052-788-6258

Homepage URL

Email

ishida@htc.nagoya-u.ac.jp

Sponsor or person

Institute

Exercise and Sports Physiology, Nagoya University, Graduate School of Medicine

Institute

Department

Personal name

Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

the Ethics Committee of Nagoya University Graduate School of Medicine

Address

65, Tsurumai, Showa-ku, Nagoya

Tel

052-744-2479

Email

ethics@med.nagoya-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

名古屋大学　総合保健体育科学センター（愛知県）
Research Center of Health, Physical Fitness and Sports, Nagoya University, Aichi, Japan

Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 01 Day

Related information

URL releasing protocol

not published

Publication of results

Unpublished

Result

URL related to results and publications

http://www.htc.nagoya-u.ac.jp/~ishida/Personal/Investigation/screeningtest.html

Number of participants that the trial has enrolled

Results

The characteristics of those who are more likely to suffer from acute mountain sickness are as follows;
1) Forced vital capacity is lower.
2) Arterial oxygen saturation falls rapidly and below 75% during hypoxic exercise.
3) End tidal partial pressure of CO2 is always higher during rest and exercise.

Results date posted

2022 Year 02 Month 26 Day

Results Delayed

Delay expected

Results Delay Reason

Because there is a lot of data to analyze.

Date of the first journal publication of results

Baseline Characteristics

Healthy adults

Participant flow

Young healthy participants applied through the university's research participation system. Older healthy participants applied through the local community.

Adverse events

nothing

Outcome measures

SpO2
AMS score
Cardio-respiratory response
Respiratory capacity

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 08 Month 31 Day

Date of IRB

2016 Year 08 Month 22 Day

Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 05 Month 31 Day

Date trial data considered complete

2017 Year 07 Month 31 Day

Date analysis concluded

2020 Year 03 Month 31 Day

Other

Other related information

The No. of intervention arms should be 24 arms becuase our experimental conditions are four, the rest arms are as follows;
(Gra=Gradual hypoxia, Acu=Acute hypoxia, Poi=Poikilocapnea, Iso=Isocapnea, Nor=Normoxia)
Arm11: Gra+Iso->Nor+Poi->Gra+Poi->Acu+Poi
Arm12: Gra+Iso->Nor+Poi->Acu+Poi->Gra+Poi
Arm13: Acu+Poi->Gra+Poi->Gra+Iso->Nor+Poi
Arm14: Acu+Poi->Gra+Poi->Nor+Poi->Gra+Iso
Arm15: Acu+Poi->Gra+Iso->Gra+Poi->Nor+Poi
Arm16: Acu+Poi->Gra+Iso->Nor+Poi->Gra+Poi
Arm17: Acu+Poi->Nor+Poi->Gra+Poi->Gra+Iso
Arm18: Acu+Poi->Nor+Poi->Gra+Iso->Gra+Poi
Arm19: Nor+Poi->Gra+Poi->Gra+Iso->Acu+Poi
Arm20: Nor+Poi->Gra+Poi->Acu+Poi->Gra+Iso
Arm21: Nor+Poi->Gra+Iso->Gra+Poi->Acu+Poi
Arm22: Nor+Poi->Gra+Iso->Acu+Poi->Gra+Poi
Arm23: Nor+Poi->Acu+Poi->Gra+Poi->Gra+Iso
Arm24: Nor+Poi->Acu+Poi->Gra+Iso->Gra+Poi
They are performed every 2 conditions per day with one hour rest, and more than one week interval between each measurement day.
Hypoxia; FIO2=13%, Exercise; 40%Max, 20min (first 5min in normoxia) cycle exercise.

Management information

Registered date

2016 Year 02 Month 23 Day

Last modified on

2024 Year 03 Month 04 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024386

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name