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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043964
Receipt No. R000050212
Scientific Title Development of a new exercise therapy for short-term effect in hemodialysis patients with diabetic nephropathy
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/19

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Basic information
Public title Development of a new exercise therapy for short-term effect in hemodialysis patients with diabetic nephropathy
Acronym Development of a new exercise therapy for short-term effect in hemodialysis patients with diabetic nephropathy
Scientific Title Development of a new exercise therapy for short-term effect in hemodialysis patients with diabetic nephropathy
Scientific Title:Acronym Development of a new exercise therapy for short-term effect in hemodialysis patients with diabetic nephropathy
Region
Japan

Condition
Condition Diabetic nephropathy
Classification by specialty
Endocrinology and Metabolism Nephrology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. Comparison of toe pinch force between hemodialysis patients with diabetic nephropathy and healthy subjects.
2. To examine the effectiveness of short-term toe resistance training.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in toe pinch force
Key secondary outcomes Exercise persistence rate

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Aerobic exercise
Toe resistance training
Interventions/Control_2 Aerobic 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
30 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Diabetic nephropathy patients who gave consent for this study
Key exclusion criteria 1. Patients having acute metabolic disorders.
2. Patients with acute or chronic bone and joint disease, and cerebral vascular disease.
3. Patients having foot/toe deformity, and edema of the foot.
4. Patients whose daily activities are highly restricted.
5. Patients who seem inappropriate for this study by investigations.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Kataoka
Organization Okayama Healthcare Professional University
Division name Department of Physical Therapy, Faculty of Health Sciences
Zip code 700-0913
Address 3-2-18, Daiku, Kitaku, Okayama 700-0913, Japan
TEL 086-233-8020
Email h.kataoka59@gmail.com

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Kataoka
Organization Okayama Healthcare Professional University
Division name Department of Physical Therapy, Faculty of Health Sciences
Zip code 700-0913
Address 3-2-18, Daiku, Kitaku, Okayama 700-0913, Japan
TEL 086-233-8020
Homepage URL
Email h.kataoka59@gmail.com

Sponsor
Institute Okayama Healthcare Professional University
Institute
Department

Funding Source
Organization Japan Association for Diabetes Education and Care
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Review Committee, Okayama Healthcare Professional University
Address 3-2-18, Daiku, Kitaku, Okayama 700-0913, Japan
Tel 086-233-8020
Email somu@apu.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 KKR高松病院、おさふねクリニック、小畑醫院

Other administrative information
Date of disclosure of the study information
2021 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
2021 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 10 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 19 Day
Last modified on
2021 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050212

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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