UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057528 |
|---|---|
| Receipt number | R000065705 |
| Scientific Title | A Study on the Effects of Exercise Menu Suggestions Based on Foot Information on the Alleviation of Bodily Pain |
| Date of disclosure of the study information | 2025/04/07 |
| Last modified on | 2025/05/04 19:20:50 |
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Basic information
Public title
A Study on the Effects of Exercise Menu Suggestions Based on Foot Information on the Alleviation of Bodily Pain
Acronym
A Study on the Effects of Exercise Menu Suggestions Based on Foot Information on the Alleviation of Bodily Pain
Scientific Title
A Study on the Effects of Exercise Menu Suggestions Based on Foot Information on the Alleviation of Bodily Pain
Scientific Title:Acronym
A Study on the Effects of Exercise Menu Suggestions Based on Foot Information on the Alleviation of Bodily Pain
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the continued implementation of exercise menu suggestions based on foot information contributes to the alleviation of knee, lower back, and shoulder pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Correlation Between Exercise Programs Suggested Based on Foot Information and Pain in the Knee, Lower Back, and Shoulder
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Visited once a week for a total of 12 weeks,
with an exercise habit intervention based on foot-related information
Interventions/Control_2
Visited once a week for a total of 12 weeks,
without an exercise habit intervention based on foot-related information
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
| 14 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. male and female participants aged between 14 and 69 years at the time of obtaining consent through to the end of the study
2. individuals experiencing pain in the knee, lower back, or shoulder
3. individuals who have sufficient capacity to consent, have received a thorough explanation of the study's purpose and content, have fully understood it, and have voluntarily agreed to participate by signing a written consent form
Key exclusion criteria
1.women who are pregnant (including those who may be pregnant) or currently breastfeeding
2.individuals who have been diagnosed with a disease related to the shoulder, lower back, knee, or foot within the past six months (those with pain but without a diagnosis are eligible to participate)
3.individuals whose NRS scores for the knee, lower back, and shoulder are all below 3, as reported in the questionnaire
4.women who are pregnant (including those who may be pregnant) or currently breastfeeding
5.individuals who have been diagnosed with a disease related to the shoulder, lower back, knee, or foot within the past six months (those with pain but without a diagnosis are eligible to participate)
6.individuals whose NRS scores for the knee, lower back, and shoulder are all below 3, as reported in the questionnaire
7.individuals with missing parts of the foot - such as toes or heel - that prevent full contact of the sole with the measurement device surface
8.individuals with allergies to any of the materials or components used in the devices or measurement instruments employed in this study
9.individuals who are unable to perform the full set of recommended exercises
10.individuals currently participating in another clinical study or who have participated in one within the past 4 weeks
11.individuals who, on the day of the examination, have injuries, dizziness, or other conditions that, in the judgment of the supervising physician, prevent them from safely maintaining a standing position or engaging in physical activity
12.any other individuals deemed unsuitable for participation by the study institution
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | |
| Last name | Hirohata |
Organization
Public Foundation of Kansai Research Institute
Division name
Office of Industrial and Innovation Promotion /Center for New Industry Creation and Exchange
Zip code
619-0237
Address
1-7 Hikaridai, Seikacho, Sorakugun, Kyoto, Japan
TEL
0774-98-2235
t-hirohata@kri.or.jp
Public contact
Name of contact person
| 1st name | Junki |
| Middle name | |
| Last name | Yamamura |
Organization
Suntory Wellness Limited
Division name
Service Promotion Department
Zip code
105-0011
Address
2-4-1 Shibakoen, Minato-ku, Tokyo, Japan
TEL
050-3182-0474
Homepage URL
Junki_Yamamura@suntory.co.jp
Sponsor or person
Institute
Conditioning Lab Limited
Institute
Department
Personal name
Funding Source
Organization
Advanced Telecommunications Research Institute International (ATR)
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
Research Ethics Review Committee, Kansai Science City Foundation
Address
Seikacho, Sorakugun, Kyoto
Tel
0774-98-2235
t-hirohata@kri.or.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
| 2025 | Year | 04 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 09 | 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
| 2025 | Year | 04 | Month | 06 | Day |
Last modified on
| 2025 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065705
