UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047428 |
|---|---|
| Receipt number | R000054037 |
| Scientific Title | The stratified analysis on the preventive and therapeutic effects of increased physical fitness by long termed interval walking training on age-associated diseases in middle-aged and older people |
| Date of disclosure of the study information | 2022/04/11 |
| Last modified on | 2022/04/07 10:25:27 |
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Basic information
Public title
The study on the preventive and therapeutic effects of increased physical fitness by interval walking training on age-associated diseases in middle-aged and older people
Acronym
The study on effects of increased physical fitness by interval walking training on age-associated diseases
Scientific Title
The stratified analysis on the preventive and therapeutic effects of increased physical fitness by long termed interval walking training on age-associated diseases in middle-aged and older people
Scientific Title:Acronym
The stratified analysis on the effects of increased physical fitness by interval walking training on age-associated diseases
Region
| Japan |
Condition
Condition
Age associated diseases
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Neurology |
| Psychosomatic Internal Medicine | Geriatrics | Orthopedics |
| Anesthesiology | Laboratory medicine | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the preventive and therapeutic effects of increased physical fitness by interval walking training for 5 months on age-associated diseases in middle-aged and older people
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The maximal aerobic capacity before and after interval walking training for 5 months.
Key secondary outcomes
Age-associated disease symptoms; the symptoms of life-style related diseases (hypertension, hyperglycemia, obesity and dyslipidemia), orthopedic diseases (chronic osteoarthritis and osteoporosis), and psychiatric disorders (insomnia, depression, and dementia)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Interval walking training
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who can walk independently.
2) Those who have received their home doctors' permission to participate in the study.
3) Those who gave us their informed consents after explained about the details of the study.
Key exclusion criteria
1) Those who do not meet the inclusion criteria.
2) Those who are judged to be inappropriate for participating the study by the lead principal investigator.
Target sample size
2000
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
TEL
0263372682
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 Matsumoto Nagano
TEL
0263372682
Homepage URL
masuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 Matsumoto Nagano
Tel
0263372572
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
| 2022 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2005 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2005 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2005 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054037
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
