UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045718 |
|---|---|
| Receipt number | R000052190 |
| Scientific Title | The evaluation of factors that contributes to the effect by the physical therapy for hemodialysis patients |
| Date of disclosure of the study information | 2021/10/15 |
| Last modified on | 2021/10/14 23:09:22 |
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Basic information
Public title
The evaluation of factors that contributes to the effect by the physical therapy for hemodialysis patients
Acronym
The evaluation of factors that contributes to the effect by the physical therapy for hemodialysis patients
Scientific Title
The evaluation of factors that contributes to the effect by the physical therapy for hemodialysis patients
Scientific Title:Acronym
The evaluation of factors that contributes to the effect by the physical therapy for hemodialysis patients
Region
| Japan |
Condition
Condition
hemodialysis patients
Classification by specialty
| Medicine in general | Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the effects of physical therapy on hemodialysis patients and identify the factors that influence them.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in physical function (SPPB, grip strength), ADL evaluation (questionnaire method), and clinical parameters of blood sampling (nutrition, oxidative stress) at six and twelve months after the start of physical therapy.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
physical therapy during each dialysis session
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
dialysis patients who visit our outpatient clinic and have given written consent to physical therapy during hemodialysis at our hospital
Key exclusion criteria
Patients with contraindications to physical therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Ino |
Organization
toda central general hospital
Division name
Department of Nephrology
Zip code
335-0023
Address
1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
TEL
0484421111
pikkun46@hotmail.com
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Ino |
Organization
Toda Central General Hospital
Division name
Department of Nephrology
Zip code
335-0023
Address
1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
TEL
335-0023
Homepage URL
pikkun46@hotmail.com
Sponsor or person
Institute
Toda Central General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Toda Central General Hospital
Address
1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
Tel
0484421111
pikkun46@hotmail.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
| 2021 | Year | 10 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 14 | 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 | 10 | Month | 11 | Day |
Last modified on
| 2021 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052190
