UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039246 |
|---|---|
| Receipt number | 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 11:59:31 |
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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
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
maenos@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Division of Nursing Science, Department of Health Sciences, Faculty of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044747
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
