UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040752
Receipt number R000046528
Scientific Title The effects of interval walking training in semi-high altitude on physical fitness and health promotion in middle-aged and older people
Date of disclosure of the study information 2020/06/13
Last modified on 2020/06/13 15:49:39

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Basic information

Public title

The effects of interval walking training in semi-high altitude on physical fitness and health promotion

Acronym

Health promotion effects of walking training in semi-high altitude

Scientific Title

The effects of interval walking training in semi-high altitude on physical fitness and health promotion in middle-aged and older people

Scientific Title:Acronym

Health promotion effects of walking training in semi-high altitude in middle-aged and older people

Region

Japan


Condition

Condition

Life-style related diseases

Classification by specialty

Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine whether interval walking training for 10 weeks in semi-high altitude (1750m)improve physical fitness and the symptoms of life-style related diseases more than that in low altitude (540m)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Peak aerobic capacity

Key secondary outcomes

Anthropological variabales (body weight, %fat, muscle mass), muscle strength, blood constituents (hemoglobin concentration, fasting blood glucose, lipids, HbA1c), arterial blood oxygen saturation during exercise (SpO2), arterial blood pressure at rest, exercise intensity and volume during training, psychological status


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Interval walking training in low altitude (540m)

Interventions/Control_2

Interval walking training in semi-high altitude (1750m)

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

50 years-old <=

Age-upper limit

74 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Men and women whose age ranges from 50 to 74 yrs.
2) Those who can walk independently.
3) Those who can use a portable carolimeter which we prepare.
4) Those who agree with participating in the study with informed consent after satisfactory explanation by us.

Key exclusion criteria

1) Those who do not clear the inclusion criteria.
2) Those who suffer from any diseases to disturb them to partcipating the study; cardiorespiratory and orthopedic diseases, that a primary invesigator judges.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Shizue
Middle name
Last name Masuki

Organization

Shinshu University

Division name

Graduate School of Medicine

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto, Nagano Prefecture

TEL

0263-37-2682

Email

masuki@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Shizue
Middle name
Last name Masuki

Organization

Shinshu University

Division name

Graduate School of Medicine

Zip code

390-8621

Address

3-1-1 Asahi, Matumoto, Nagano Prefecture

TEL

0263-37-2682

Homepage URL


Email

masuki@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Japan Health Promotion & Fitness Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Shinshu University School of Medicine

Address

3-1-1 Asahi, Matumoto, Nagano Prefecture

Tel

0263-37-2572

Email

mdrinri@shinshu-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

2020 Year 06 Month 13 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

Enrolling by invitation

Date of protocol fixation

2020 Year 06 Month 08 Day

Date of IRB

2020 Year 06 Month 08 Day

Anticipated trial start date

2020 Year 06 Month 08 Day

Last follow-up date

2020 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 06 Month 13 Day

Last modified on

2020 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046528


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name