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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039246
Receipt No. R000044747
Scientific Title Effect of continuous use of intensity-type activity meter in exercise therapy for diabetic patients
Date of disclosure of the study information 2020/01/25
Last modified on 2020/01/24

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Basic information
Public title Effect of continuous use of intensity-type activity meter in exercise therapy for diabetic patients
Acronym Effect of continuous use of intensity-type activity meter in exercise therapy for diabetic patients
Scientific Title Effect of continuous use of intensity-type activity meter in exercise therapy for diabetic patients
Scientific Title:Acronym Effect of continuous use of intensity-type activity meter in exercise therapy for diabetic patients
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of continuous use of an activity meter that can monitor medium-intensity physical activity in supporting physical activity of type 2 diabetes patients.To clarify the relationship between physical activity and sleep.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of changes in physical activity between the intervention group and the control group
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Using an activity meter,Self-monitoring of physical activity
Interventions/Control_2 Normal exercise therapy
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Type 2 diabetic patients on outpatient medical treatment.
2) Patients aged 40 years or older and 80 years or younger living near Fukuoka City
3) Patients more than 6 months after the diagnosis of diabetes.
4) Exercise with moderate or higher activity intensity is effective, and exercise therapy is recommended by a doctor.
5) Patients who obtained written consent.
Key exclusion criteria 1) Patients whose HbA1c level exceeds 10.0%.
2) Patients with advanced complications due to diabetes.
3) Patients with limited or difficult exercise and physical activity due to medical condition or co-morbidity.
4) Patients treated with sleep disorders.
5) Patients who have difficulty with self-administered questionnaire survey.
6) Other patients judged inappropriate by the attending physician or researcher.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Satoko
Middle name
Last name Maeno
Organization Kyushu University
Division name Division of Nursing Science, Department of Health Sciences, Faculty of Medical Sciences
Zip code 812-8582
Address 3-1-1 Maidashi Higashi-ku Fukuoka
TEL 092-642-6917
Email maenos@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Satoko
Middle name
Last name Maeno
Organization Kyushu University
Division name Division of Nursing Science, Department of Health Sciences, Faculty of Medical Sciences
Zip code 812-8582
Address 3-1-1 Maidashi Higashi-ku Fukuoka
TEL 092-642-6917
Homepage URL
Email maenos@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Division of Nursing Science, Department of Health Sciences, Faculty of Medical Sciences
Institute
Department

Funding Source
Organization JST
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 Center for Clinical and Translational Research(CCTR) of Kyushu University Hospital
Address 3-1-1 Maidashi Higashi-ku Fukuoka
Tel 092-642-5774
Email tr-info@med.kyushu-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
2020 Year 01 Month 25 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 95
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 No longer recruiting
Date of protocol fixation
2019 Year 02 Month 01 Day
Date of IRB
2018 Year 12 Month 10 Day
Anticipated trial start date
2019 Year 02 Month 08 Day
Last follow-up date
2020 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
2020 Year 01 Month 24 Day
Last modified on
2020 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044747

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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