UMIN-CTR Clinical Trial

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
Institute	Shinshu University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046528