UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046773 |
|---|---|
| Receipt number | R000053343 |
| Scientific Title | If-then Plan for Increasing Physical Activity in Patients with Type 2 Diabetes |
| Date of disclosure of the study information | 2022/02/20 |
| Last modified on | 2023/08/03 22:47:35 |
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Basic information
Public title
If-then Plan for Increasing Physical Activity in Patients with Type 2 Diabetes
Acronym
If-then Plan for Increasing Physical Activity in Patients with Type 2 Diabetes
Scientific Title
If-then Plan for Increasing Physical Activity in Patients with Type 2 Diabetes
Scientific Title:Acronym
If-then Plan for Increasing Physical Activity in Patients with Type 2 Diabetes
Region
| Japan |
Condition
Condition
type2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been reported that exercise therapy, one of the treatments for diabetes mellitus, is often not supervised, and even when supervised, about half of the patients do not continue to exercise. Therefore, in order to maintain and improve glycemic control, it is necessary to provide guidance and intervention methods that promote behavioral change so that patients can continue to exercise. Recently, it has been suggested that the concept of intention to perform may influence changes in behavioral change. In this study, we will examine the effects of exercise instruction using the if-then plan on the amount of physical activity before and after the instruction in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity before and after hospitalization for 10 days
Key secondary outcomes
Age,gender,physical function,cognitive function,Short Physical Performance Battery,Japanese Montreal Cognitive Assessment,muscle strength,Barthel Index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
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
A total of four interventions of 40 minutes each will be conducted during the 8-14 day educational hospitalization.Provide exercise instruction using an if-then plan.
Interventions/Control_2
A total of four interventions of 40 minutes each will be conducted during the 8-14 day educational hospitalization.Provide normal exercise instruction.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who will be admitted to the Diabetes Education Hospilization at Okayama City Hospital. Patients with no history of serious circulatory disorders, osteoarticular disorders, respiratory disorders, peripheral circulatory disorders, cerebral neuropathy, severe sensory disorders, or severe visual disorders. Those who have obtained the free written consent of the research subject for participation in this study with full understanding.
Key exclusion criteria
Those with a history of serious circulatory disorder, osteoarticular disease, respiratory disease, peripheral circulatory disease, cerebral nerve disorder, severe sensory disorder, or severe visual disorder. Those with dermatitis on the thighs or those who are prone to contact dermatitis. Those who have been diagnosed by a physician as contraindicated for exercise therapy. Those who have not given their free written consent to participate in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | haruka |
| Middle name | |
| Last name | narita |
Organization
Okayama City Hospital
Division name
Department of Rehabilitation Technology
Zip code
700-8557
Address
20-1, 3-chome, Kitanagase Omote-cho, Kita-ku, Okayama City, Okayama Prefecture,JAPAN
TEL
086-737-3000
pokiretsu8@gmail.com
Public contact
Name of contact person
| 1st name | haruka |
| Middle name | |
| Last name | narita |
Organization
Okayama City Hospital
Division name
Department of Rehabilitation Technology
Zip code
700-8557
Address
20-1, 3-chome, Kitanagase Omote-cho, Kita-ku, Okayama City, Okayama Prefecture,JAPAN
TEL
086-737-3000
Homepage URL
pokiretsu8@gmail.com
Sponsor or person
Institute
Okayama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Hyogo Medical 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
Okayama City Hospital
Address
20-1, 3-chome, Kitanagase Omote-cho, Kita-ku, Okayama City, Okayama Prefecture,JAPAN
Tel
086-737-3000
pokiretsu8@gmail.com
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
| 2022 | Year | 02 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053343
