UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039235 |
|---|---|
| Receipt number | R000044729 |
| Scientific Title | Exploratory study on improvement of physical ability by voluntary training for type 2 diabetic patients |
| Date of disclosure of the study information | 2020/01/23 |
| Last modified on | 2023/05/03 09:25:17 |
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Basic information
Public title
Exploratory study on improvement of physical ability by voluntary training for type 2 diabetic patients
Acronym
Exploratory study of physical ability improvement for type 2 diabetes patients
Scientific Title
Exploratory study on improvement of physical ability by voluntary training for type 2 diabetic patients
Scientific Title:Acronym
Exploratory study of physical ability improvement for type 2 diabetes patients
Region
| Japan |
Condition
Condition
Type 2 diabetics
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to collect basic data to develop an exercise program that can be used as a voluntary training program at home to prevent falls after discharge from high-risk type 2 diabetes patients with falls .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee extension strength after 12 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Resistance exercise
Interventions/Control_2
Balance exercise
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 who can walk independently and have independent living activities
Patients who have been evaluated for physical ability by a physiotherapist during the hospitalization period
High-risk falls from the fall prediction criteria
Key exclusion criteria
Exclusion criteria include patients with active proliferative retinopathy, patients with NYHA II or higher heart failure, patients being treated for malignancies, patients taking glucocorticoids, patients with Cushing's syndrome who need treatment, and Patients with sickness, patients after gastrectomy, patients with gait disorders (non-gait independence) as movement disorders in the hip and knee joints, patients with paralysis (including paresis) due to central nervous system disorders, neuropathy due to causes other than diabetes (Low back pain, spinal canal stenosis, etc.), patients with cognitive impairment (lack of communication ability) having difficulty in understanding instructions, and patients with missing values in acquired data during hospitalization.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | yasuhiro |
| Middle name | |
| Last name | suzuki |
Organization
University of Tsukuba Hospital
Division name
Department of Rehabilitation ,Medicine
Zip code
3050044
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
TEL
09062872557
minaminagasaki2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | yasuhiro |
| Middle name | |
| Last name | suzuki |
Organization
University of Tsukuba Hospital
Division name
Department of Rehabilitation ,Medicine
Zip code
3050044
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
TEL
09062872557
Homepage URL
minaminagasaki2007@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba Hospital
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
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
Tel
09062872557
minaminagasaki2007@yahoo.co.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 | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2021 | 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 | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044729
| 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 |
