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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037202
Receipt No. R000042413
Scientific Title Effect of continuous group exercise on physical function in the patients with diabetes mellitus
Date of disclosure of the study information 2019/06/27
Last modified on 2019/06/27

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Basic information
Public title Effect of continuous group exercise on physical function in the patients with diabetes mellitus
Acronym Effect of continuous group exercise on physical function in the patients with diabetes mellitus
Scientific Title Effect of continuous group exercise on physical function in the patients with diabetes mellitus
Scientific Title:Acronym Effect of continuous group exercise on physical function in the patients with diabetes mellitus
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Purpose of this study is effect of continuous group exercise on physical function in the patients with diabetes mellitus

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes As a person who falls under the physical function, it is evaluated according to the applicable criteria of Locomotive syndrome and Sarcopenia, and the existing finding rate and the new incidence rate are calculated as%. For each finding rate, the first test and the last test are subjected to the chi-square test. Comparison of changes in physical function and metabolic index at the first group exercise instruction and at the last group exercise instruction one year later using the corresponding t-test.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Effect of continuous group exercise on physical function
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Diabetes patients who are admitted to our hospital for the treatment of diabetes, or outpatients, who belong to the border type.
2) Those who are independent of ADL and can live by walking.
3) Those who are 20 years of age or older at the time of consent.
4) A person who has obtained written consent from the person regarding research participation
Key exclusion criteria 1) Person who is diagnosed with pregnancy diabetes, diabetes merger pregnancy
2) Persons who have acute diabetes complications (hypoglycemia, ketoacidosis diabetes, hyperglycemia hyperosmotic syndrome)
3) Those who have corresponding items when it is better to ban or restrict exercise therapy
1 When the metabolic control of diabetes is extremely bad (urine ketone body is moderately positive or more)
2 If there is fresh fundus hemorrhage due to proliferative retinopathy
3 If there is a tendency for deterioration of kidney function
4 If heart failure is aggravating
5) Pain or inflammation caused by bone or joint disease
4) Person who is difficult to intervene in exercise as diabetes treatment guidance by being bedridden
5) If the attending doctor has dementia and is not suitable for group exercise instruction
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Akihito
Middle name
Last name Noguchi
Organization Shimane University Faculty of Medicine
Division name Rehabilitation
Zip code 6938501
Address Shimane Prefecture Izumo City enyacho 89-1
TEL 0853232111
Email anoguchi@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Akihito
Middle name
Last name Noguchi
Organization Shimane University Faculty of Medicine
Division name Rehabilitation
Zip code 6938501
Address Shimane Prefecture Izumo City enyacho 89-1
TEL 0853232111
Homepage URL
Email anoguchi@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shimane University Faculty of Medicine
Address Shimane Prefecture Izumo City enyacho 89-1
Tel 0853202515
Email kenkyu@med.shimane-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
2019 Year 06 Month 27 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
2017 Year 11 Month 14 Day
Date of IRB
2017 Year 11 Month 14 Day
Anticipated trial start date
2017 Year 11 Month 14 Day
Last follow-up date
2023 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
2019 Year 06 Month 27 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042413

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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