UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036439 |
|---|---|
| Receipt number | R000041523 |
| Scientific Title | Evaluation of the effects of continuous interval walking on orofacial function |
| Date of disclosure of the study information | 2019/04/10 |
| Last modified on | 2024/04/11 10:08:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the effects of continuous interval walking on orofacial function
Acronym
Interval walking and orofacial function
Scientific Title
Evaluation of the effects of continuous interval walking on orofacial function
Scientific Title:Acronym
Interval walking and orofacial function
Region
| Japan |
Condition
Condition
Oral hypofunction
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect on orofacial function by interval walking exercise
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in oral function
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Five months walk training
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The intervention group is elderly people aged 50 and over who participate in interval walk training at Matsumoto City Middle School Physical Education college.
The control group is a patient who is visiting the Niigata University Medical and Dental Hospital, or a volunteer by recruiting.
Key exclusion criteria
1) Those who have difficulty walking
2) A person who has suffered from respiratory or circulatory disease or orthopedic disease and it is judged that it is difficult to continue study participation as a subject
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinsyu University
Division name
Graduate School of Medicine
Zip code
3908621
Address
Asahi3-1-1, Matumoto
TEL
0263372682
masuki@shinsyu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinsyu University
Division name
Graduate School of Medicine
Zip code
3908621
Address
Asahi3-1-1, Matumoto-shi
TEL
0263372682
Homepage URL
masuki@shinsyu-u.ac.jp
Sponsor or person
Institute
Shinsyu University
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University
Address
5274, Gakkocho-dori 2-bancho, Chuo-ku, Niigata,
Tel
025-227-2891
cem17150@dent.niigata-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
| 2019 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
On going
Publication of results
Unpublished
Result
URL related to results and publications
Participants are being recruited - test is ongoing
Number of participants that the trial has enrolled
150
Results
Call for Participants Closed - Testing Ongoing
Results date posted
| 2024 | Year | 04 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Call for Participants Closed - Testing Ongoing
Participant flow
Call for Participants Closed - Testing Ongoing
Adverse events
None at present
Outcome measures
On going
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 04 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041523
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
