UMIN-CTR Clinical Trial

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
Email	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
Email	masuki@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052914