UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054585 |
|---|---|
| Receipt number | R000062373 |
| Scientific Title | Verification of the effect of gait measurement on the body |
| Date of disclosure of the study information | 2024/06/06 |
| Last modified on | 2024/06/06 09:30:59 |
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Basic information
Public title
Verification of the effects of exercise on the body
Acronym
Verification of the effects of exercise on the body
Scientific Title
Verification of the effect of gait measurement on the body
Scientific Title:Acronym
Verification of the effects of exercise on the body
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of exercises on the body.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical activity after 12 weeks of exercise.
Key secondary outcomes
-Flexibility
-Range of motion
-Body weight
-Visceral fat area
-Subjective
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Perform the specified exercises for 12 weeks.
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
| 35 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who have a desire to lose weight (diet) but cannot continue strenuous exercise or diet restrictions.
2) Those who agree to participate in daily exercises, questionnaires to record exercises, and wearing an activity tracker.
Key exclusion criteria
(1) Those who have pain or injury that affects their ability to walk or perform the exercises.
(2) Those who have had surgery in the past and have difficulty walking normally.
(3) Those with pacemakers or metal objects (stents or clips) in the body
(4) Those with strong metal allergies or abdominal skin diseases
(5) Those who are pregnant or may become pregnant
(6) Patients with a BMI less than the standard (less than 18.5)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Motoki |
| Middle name | |
| Last name | Sudo |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-80-8866-6133
sudou.motoki@kao.com
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Seo |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-80-7956-8400
Homepage URL
seo.kanako@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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
| 2024 | Year | 06 | Month | 06 | 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
40
Results
Matched exercises were performed for 12 weeks. Flexibility and joint range of motion improved.
Results date posted
| 2024 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
22 males, 18 females
Average age 46.9 years old
Participant flow
40 at the start of the exam. 3 people left during the exam due to illness unrelated to the exam.
Adverse events
Not applicable
Outcome measures
Flexibility, Joint range of motion
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062373
