UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042273 |
|---|---|
| Receipt number | R000048254 |
| Scientific Title | Functional recovery in post-stroke patients on hemodialysis during the convalescent phase; a comparison with those not undergoing hemodialysis |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2022/05/10 09:21:49 |
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Basic information
Public title
Study on the nutritional status of hemodialysis patients and the necessity of rehabilitation
Acronym
Recovery in post-stroke patients on hemodialysis
Scientific Title
Functional recovery in post-stroke patients on hemodialysis during the convalescent phase; a comparison with those not undergoing hemodialysis
Scientific Title:Acronym
Recovery in post-stroke patients on hemodialysis
Region
| Japan |
Condition
Condition
hemodialysis patient
Classification by specialty
| Nephrology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the difference of functional recovery during the convalescent phase between post-stroke patients with and without hemodialysis
Basic objectives2
Others
Basic objectives -Others
The secondary purpose of this study is to clarify the difference of nutrition status during the convalescent phase between post-stroke patients with and without hemodialysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is walking ability and Ability of daily living at discharge
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Comprehensive rehabilitation in convalescent rehabilitation hospital
Interventions/Control_2
Comprehensive rehabilitation in convalescent rehabilitation hospital with maintenance hemodialysis
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with a diagnosis of stroke
2) Hemiparesis at the admission to convalescent rehabilitation hospital
3) Walking disturbance due to the hemiparesis
4) Age at the admission between 18-100 years
Key exclusion criteria
1) Time between the stroke onset and the admission to convalescent rehabilitation hospital of more than 90 days
2) History of multiple stroke at admission
3) Have active physical or mental illness requiring acute medical management
4) Have significant disturbance of consciousness at the admission
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Takeki |
| Middle name | |
| Last name | Ishida |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Rehabilitation Medicine
Zip code
272-0827
Address
6-1-14 Kounodai, Ichikawa city, Chiba 272-0827 Japan
TEL
0473751111
17s3008@g.iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Takeki |
| Middle name | |
| Last name | Ishida |
Organization
International University of Health and Welfare Ichikawa Hospital
Division name
Department of Rehabilitation Medicine
Zip code
272-0827
Address
6-1-14 Kounodai, Ichikawa city, Chiba 272-0827 Japan
TEL
0473751111
Homepage URL
17s3008@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
International University of Health and Welfare Ichikawa Hospital
Address
6-1-14 Kounodai, Ichikawa city, Chiba 272-0827 Japan
Tel
0473751111
s-rinri@iuhw.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://rrtjournal.biomedcentral.com/articles/10.1186/s41100-021-00347-7
Publication of results
Unpublished
Result
URL related to results and publications
https://rrtjournal.biomedcentral.com/articles/10.1186/s41100-021-00347-7
Number of participants that the trial has enrolled
92
Results
Hemoglobin albumin,eGFR GNRI and grip strength at admission were significantly lower in hemodialysis group than nonhemodialysis group
In hemodialysis group on the other hand FIM motor score was significantly lower than non-hemodialysis group
frequency of FAC 3 at discharge was significantly lower in hemodialysis group
than non-hemodialysis group
Results date posted
| 2022 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
age 79 years
female 46
BMI 21.3kg/m2
length of stay at hospital 85 days
hemodialysis group 10 patients
non-hemodialysis group 72 patients
Participant flow
recruited patients 144 patients.
disturbance of consciousness at the admission 27
history of stroke 6
independence walking on admission 8
need acute medical management 16
missing data of FAC 5
Finally, we included 82 patients in our study
Adverse events
No patient experienced any severe complications associated with hemodialysis during the admission
Outcome measures
Primary outcome
FIM FAC at discharge
Secondary outcome
GNRI, grip strength at admission
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | 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 | 10 | Month | 28 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048254
