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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039235
Receipt No. 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 2020/01/23

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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
Email 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
Email minaminagasaki2007@yahoo.co.jp

Sponsor
Institute University of Tsukuba Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 01 Month 23 Day
Date of IRB
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
2020 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044729

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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