UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050903 |
|---|---|
| Receipt number | R000058013 |
| Scientific Title | The effect of telerehabilitation for patients with type 2 diabetes on the risk of cardiac disease |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/04/21 16:43:36 |
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Basic information
Public title
The effect of telerehabilitation for patients with type 2 diabetes on the risk of cardiac disease
Acronym
Effect of telerehabilitation for patients with type 2 diabetes
Scientific Title
The effect of telerehabilitation for patients with type 2 diabetes on the risk of cardiac disease
Scientific Title:Acronym
Effect of telerehabilitation for patients with type 2 diabetes
Region
| Japan |
Condition
Condition
patients with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the purpose of this study is to examine the effect of telerehabilitation for patients with type 2 diabetes, on the risk of cardiac disease and to determine the usefulness of telerehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac disease incident followed up 1 year after telerehabilitation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
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
standard exercise instruction + telerehabilitation
Interventions/Control_2
standard 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with type 2 diabetes
2. Outpatients
Key exclusion criteria
1. age < 20 years
2. Patients with Gait disturbance
3. Patients with severe musculoskeletal symptoms
4. Patinets with diabetes foot or lower extremity amputation
5. Patients with cognitive impairment
6. Patients contraindications to exercise training
7. Patients unable to consent
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takeki |
| Middle name | |
| Last name | Ishida |
Organization
School of Health Sciences at Narita, International University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
286-8686
Address
4-3 Kozunomori, Narita city, Chiba, Japan
TEL
0476-20-7717
takekii@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Takeki |
| Middle name | |
| Last name | Ishida |
Organization
School of Health Sciences at Narita, International University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
286-8686
Address
4-3 Kozunomori, Narita city, Chiba, Japan
TEL
0476-20-7717
Homepage URL
takekii@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Takeki Ishida
Funding Source
Organization
Japan Science and Technology Agency
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
Ethics review committee, International University of Health and Welfare
Address
4-3 Kozunomori, Narita city, Chiba, Japan
Tel
0476-20-7708
rinri_md@iuhw.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
| 2023 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 04 | Month | 21 | Day |
Last modified on
| 2023 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058013
