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
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
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
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
