UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059187 |
|---|---|
| Receipt number | R000067694 |
| Scientific Title | A Study on the Effectiveness of Self-Evaluation and Corrective Exercises for Physical Function |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/09/25 16:41:20 |
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Basic information
Public title
A Study on the Effectiveness of Self-Evaluation and Corrective Exercises for Physical Function
Acronym
A Study of Self-Evaluation and Corrective Exercises for Physical Function
Scientific Title
A Study on the Effectiveness of Self-Evaluation and Corrective Exercises for Physical Function
Scientific Title:Acronym
A Study of Self-Evaluation and Corrective Exercises for Physical Function
Region
| Japan |
Condition
Condition
musculoskeletal disorders, individuals with nonspecific complaints, lifestyle-related diseases
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of Self-Evaluation and Corrective Exercises for integration into education and public health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
self-evalutaion score, visual analog scale (stiff shoulders, low back pain, etc.), questionnaire (perceived improvement level), locomotive syndrome risk test
Key secondary outcomes
vital sign (blood pressure, heart rate)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
corrective exercise
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals capable of performing light exercise who have provided informed consent to participate in the study
Key exclusion criteria
Exclusion Criteria:
- Individuals instructed by a physician to restrict physical activity
- Those with uncontrolled severe cardiovascular, respiratory, or neurological disorders
- Individuals with paroxysmal conditions (including syncope) who have not received medical clearance for exercise
- Those with neuromuscular disorders or severe balance impairments posing a high risk of falls
- Individuals for whom exercise is not recommended due to eating disorders, energy deficiency, or related conditions
- Pregnant individuals or those within three months postpartum
- Individuals with impaired capacity to provide informed consent or insufficient comprehension of Japanese
- Individuals under the age of 18
Temporary Exclusion:
Participants experiencing acute injury or postoperative status, active inflammation or fever, moderate to severe pain, uncontrolled metabolic abnormalities, marked palpitations or shortness of breath, extreme fatigue, dizziness, or intoxication will be temporarily excluded. They may be enrolled upon recovery or with approval from their attending physician.
Operational Exclusion:
Participants will be excluded if follow-up Self-Check assessments are not feasible or if consent is withdrawn.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | kota |
| Middle name | |
| Last name | watanabe |
Organization
Sapporo Medical University
Division name
department of sports medicine, School of Medicne
Zip code
060-8556
Address
South-1, West-17, Chuo-ku, Sapporo
TEL
011-611-2111
wkota@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Watanabe |
Organization
Sapporo Medical University
Division name
department of sports medicine, School of Medicne
Zip code
060-8556
Address
South-1, West-17, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
https://sapmed-spomed.com/
wkota@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University
Address
South-1, West-17, Chuo-ku, Sapporo
Tel
011-611-2111
wkota@sapmed.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
| 2025 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067694
