UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043964 |
|---|---|
| Receipt number | 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 | 2023/01/17 08:25:36 |
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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
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
h.kataoka59@gmail.com
Sponsor or person
Institute
Okayama Healthcare Professional University
Institute
Department
Personal name
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
somu@opu.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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050212
