UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049705 |
|---|---|
| Receipt number | R000056615 |
| Scientific Title | Differences in the effects of renal rehabilitation with and without diabetes |
| Date of disclosure of the study information | 2022/12/07 |
| Last modified on | 2022/12/06 16:40:03 |
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Basic information
Public title
Differences in the effects of renal rehabilitation with and without diabetes
Acronym
Differences in the effects of renal rehabilitation with and without diabetes
Scientific Title
Differences in the effects of renal rehabilitation with and without diabetes
Scientific Title:Acronym
Differences in the effects of renal rehabilitation with and without diabetes
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the difference in the effects of renal rehabilitation (rate of change in upper and lower extremity muscle strength over a one-year period) depending on the presence or absence of diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Grip strength, knee extension muscle strength, toe muscle strength
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Stretching, resistance training, aerobic exercise
Interventions/Control_2
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing renal rehabilitation among hemodialysis patients
Key exclusion criteria
1.Subjects with a history of musculoskeletal disease or cerebrovascular disease
2. Subjects who have difficulty walking due to deformities of hip joints, knee joints, ankle joints, and toes.
3. Those who are difficult to evaluate and measure
4. Subjects who were unable to continue renal rehabilitation
5. In addition, those who are judged to be inappropriate as subjects by the attending physician or the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shion |
| Middle name | |
| Last name | Nagai |
Organization
KKR Takamatsu Hospital
Division name
rehabilitation center
Zip code
760-0018
Address
4-18 Tenjinmae, Takamatsu City, Kagawa Prefecture
TEL
087-861-3261
slmdpt.22@gmail.com
Public contact
Name of contact person
| 1st name | Shion |
| Middle name | |
| Last name | Nagai |
Organization
KKR Takamatsu Hospital
Division name
rehabilitation center
Zip code
760-0018
Address
4-18 Tenjinmae, Takamatsu City, Kagawa Prefecture
TEL
087-861-3261
Homepage URL
slmdpt.22@gmail.com
Sponsor or person
Institute
KKR Takamatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
KKR Takamatsu 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
KKR Takamatsu Hospital
Address
4-18 Tenjinmae, Takamatsu City, Kagawa Prefecture
Tel
087-861-3261
slmdpt.22@gmail.com
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
| 2022 | Year | 12 | Month | 07 | 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
28
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
| 2022 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056615
