UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046372 |
|---|---|
| Receipt number | R000052914 |
| Scientific Title | Development of a new medical care model for local community based on exercise prescription by hospital (clinic) and pharmacy alignment |
| Date of disclosure of the study information | 2021/12/14 |
| Last modified on | 2021/12/14 15:26:43 |
* 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
Development of a new medical care model for local community by exercise prescription
Acronym
A medical care model for local community by exercise
Scientific Title
Development of a new medical care model for local community based on exercise prescription by hospital (clinic) and pharmacy alignment
Scientific Title:Acronym
Development of a medical care model for local community based of exercise prescription
Region
| Japan |
Condition
Condition
Life-style related diseases
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a new medical care model for treatment of life-style related diseases using interval walking training by hospital (clinic) and pharmacy alignment in local community.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical fitness (peak aerobic capacity)after a 5-month intervention period
Key secondary outcomes
Life-style related disease symptoms (bode weight, BMI, blood pressure, blood constituents) after a 5-month intervention period.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
An interval walking group
Interventions/Control_2
A sedentary group
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 aged 30-85 yrs who have visited hospitals or clinics at more than once per every 2 months for treatments of life-style related diseases.
2) Those who can walk.
3) Those who have been permitted to be subjects by their doctors in charge.
4) Those who have given us their informed consents to participated in the study after being explained about the details.
Key exclusion criteria
1) Those who do not match the above criteria.
2) Those who are judged inappropriate for participating in the study by the chief investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 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
0263372682
masuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masuki |
| Middle name | |
| Last name | Shizue |
Organization
Shinshu University
Division name
Graduate School of Medicine
Zip code
390-8621
Address
3-1-1 Asahi Matsumoto Nagano
TEL
0263372681
Homepage URL
masuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu 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
Shinshu University School of Medicine
Address
3-1-1 Asahi Matsumoto Nagano
Tel
0263372572
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
| 2021 | Year | 12 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 12 | Month | 14 | Day |
Last modified on
| 2021 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052914
