UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057124 |
|---|---|
| Receipt number | R000064630 |
| Scientific Title | Examination of the fall prevention effect of long-term self-training in type 2 diabetes patients at high risk of falling (exploratory study using a randomized parallel group trial) |
| Date of disclosure of the study information | 2025/03/13 |
| Last modified on | 2025/08/07 14:32:54 |
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Basic information
Public title
Intervention study of long-term self-training for type 2 diabetes patients
Acronym
Intervention studies targeting patients with diabetes
Scientific Title
Examination of the fall prevention effect of long-term self-training in type 2 diabetes patients at high risk of falling (exploratory study using a randomized parallel group trial)
Scientific Title:Acronym
Examination of the fall prevention effect of long-term self-training in type 2 diabetes patients at high risk of falling
Region
| Japan |
Condition
Condition
Type 2 diabetes patients
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fall prevention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of falls
Key secondary outcomes
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Resistance training
Interventions/Control_2
stretch
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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients admitted to the Department of Endocrinology, Metabolism and Diabetes at the University of Tsukuba Hospital for the purpose of diabetes treatment
Patients aged 60 to 75 years who are able to walk independently and are independent in daily living activities
Patients who can give consent to the study of their own volition
Patients whose physical ability was evaluated by a physical therapist during their hospitalization
Patients who are high-risk for falls as determined by high-risk fall indicators (taking SGLT2i or GLP-1RA drugs at the time of discharge)
Patients who own a smartphone and can freely watch YouTube at their own discretion (regardless of place, time, etc.)
Patients who can watch about 15 minutes of YouTube (videos) per day on their smartphone for 48 weeks (communication charges and expenses will be borne by the patient)
Key exclusion criteria
Patients with any of the following diabetic complications
(a) Proliferative diabetic retinopathy (excluding patients who have been stabilized with photocoagulation therapy)
(b) NYHA (New York Heart Association) II or higher
Patients undergoing chemotherapy, radiation therapy, or other treatment for malignant tumors (excluding those with a history of such a condition)
Patients taking oral corticosteroids
Patients with Cushing's syndrome or acromegaly who have not yet been treated or are currently undergoing treatment
Patients who have undergone gastrectomy
Patients with gait disorders (not able to walk independently) due to motor disorders in the hip joint, knee joint, etc.
Patients with paralysis (including incomplete paralysis) due to central nervous system disease
Patients with neuropathy due to causes other than diabetes
Patients with cognitive impairment (lack of communication skills) that makes it difficult to understand instructions
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Iwasaki |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Endocrinology and Metabolism
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
TEL
029-853-3053
iwasaki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
University of Tsukuba
Division name
Systems and Information Engineering
Zip code
3058573
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
TEL
0298536181
Homepage URL
yasuhiro@ai.iit.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Research and Development Center, University of Tsukuba
Address
2-1-1 Amakubo, Tsukuba City
Tel
0298533914
t-credo.adm@un.tsukuba.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
| 2025 | Year | 03 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 31 | 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
| 2025 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064630
