UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029623 |
|---|---|
| Receipt number | R000033839 |
| Scientific Title | The effect of exercise intervention on health status including oral health. |
| Date of disclosure of the study information | 2017/10/19 |
| Last modified on | 2023/04/24 10:03:19 |
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Basic information
Public title
The effect of exercise intervention on health status including oral health.
Acronym
The effect of exercise intervention on health status including oral health.
Scientific Title
The effect of exercise intervention on health status including oral health.
Scientific Title:Acronym
The effect of exercise intervention on health status including oral health.
Region
| Japan |
Condition
Condition
Healthy elderly people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of interval walking training for oral health status, atherosclerosis, and cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral function
Key secondary outcomes
Endothelial function, cognitive function, maximum exercise capacity, metabolic syndrome indices, body composition, activities of daily living, and quality of life
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
30minutes a day, 4 times a week, for 6 months
Interventions/Control_2
Control
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
| 64 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Volunteers who responded to recruitment by flyers.
Persons who give informed consent.
Key exclusion criteria
Persons who are unable to walk.
Persons who were instructed not to exercise by a doctor.
Target sample size
380
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Tamaki |
Organization
Osaka Medical College
Division name
Hygiene and Public Health
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki City, Osaka
TEL
0726831221
hyg052@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Kuniyasu |
| Middle name | |
| Last name | Kamiya |
Organization
Osaka Medical College
Division name
Hygiene and Public Health
Zip code
569-8686
Address
2-7, Daigaku-machi, Takatsuki City, Osaka
TEL
072-683-1221
Homepage URL
hyg052@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical College Research Ethics Committee
Address
2-7, Daigaku-machi, Takatsuki, Osaka
Tel
072-683-1221
rinri@osaka-med.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
| 2017 | Year | 10 | Month | 19 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/ggi.14530
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/ggi.14530
Number of participants that the trial has enrolled
346
Results
We compared the change in endothelial function, measured as reactive hyperemia index (RHI), between interval walking group and control group. As the result, RHI in inberval walking group was significantly larger than in control group among men, although the change in RHI was not significantly different between interval walking group and control group among women.
Results date posted
| 2023 | Year | 04 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
48 men (age: 75 +/- 5 years; exercise training group, n = 24; control group, n = 24) and 83 women (age: 75 +/- 4 years; exercise training group, n = 36; control group, n = 47)
Participant flow
Seventy-five men and 123 women applied to participate the research. We allocated 37 men and 61 women in interval walking group and 38 men and 62 women in control group. After excluding those with history of stroke or ischemic heart disease, systolic blood pressure > 180mmHg, or unable to measure RHI, we obtained baseline data of 27 men and 40 women in interval walking group and 32 men and 57 women in control group. We analyzed 24 men and 36 women in interval walking group and 24 men and 47 women in control group after excluding those who did not participate follow-up measurement, missing data of RHI in follow-up measurement, or started or discontinued the intake of drugs for high blood pressure in the interval between measurement pre- and post- intervention.
Adverse events
Nothing
Outcome measures
Reactive hyperemia index: RHI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 19 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033839
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
