UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061331 |
|---|---|
| Receipt number | R000070176 |
| Scientific Title | Development of a New Community Healthcare Model Centered on Exercise through Collaboration Between Hospitals/Clinics and Pharmacies Using a Smartphone Application |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/21 11:28:51 |
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Basic information
Public title
Development of a New Community Healthcare Model Centered on Exercise through Collaboration Between Hospitals/Clinics and Pharmacies Using a Smartphone Application
Acronym
Development of a New Community Healthcare Model Through the Smartphone Based Digitalization of Exercise Prescription
Scientific Title
Development of a New Community Healthcare Model Centered on Exercise through Collaboration Between Hospitals/Clinics and Pharmacies Using a Smartphone Application
Scientific Title:Acronym
Development of a New Community Healthcare Model Through the Smartphone Based Digitalization of Exercise Prescription
Region
| Japan |
Condition
Condition
lifestyle related diseases
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effectiveness of interval walking among patients with lifestyle related diseases attending community hospitals or clinics, using community pharmacies as the operational base.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical fitness (Peak aerobic capacity)
Key secondary outcomes
Lifestyle related disease indicators (body weight, body fat percentage, arterial blood pressure, blood components, etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
with interval walking training
Interventions/Control_2
without interval walking training
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
| 30 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with lifestyle related diseases at community hospitals or clinics who have been attending regularly for at least six months, with a visit frequency of at least once every two months.
2) Individuals who are able to walk.
3) Individuals who have obtained approval from their attending physician.
4) Individuals who, after receiving sufficient explanation about this study, have provided written informed consent based on their own free will.
Key exclusion criteria
1) Individuals who do not meet the above inclusion criteria.
2) Individuals whom the principal investigator determines to be unsuitable for participation in this study, such as those with respiratory or cardiovascular diseases, or musculoskeletal or joint disorders.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu Iniversity
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2682
masuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shizue |
| Middle name | |
| Last name | Masuki |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto Nagano
TEL
0263-37-2682
Homepage URL
masuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Graduate School of Medicine
Address
3-1-1 Asahi Matsumoto Nagano
Tel
0263-37-2527
mdrinri@shinshu-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
| 2026 | Year | 05 | 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
| 2026 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070176
