UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014547 |
|---|---|
| Receipt number | R000016663 |
| Scientific Title | The relationship between physical activity level and arterial stiffness in chronic kidney disease patients |
| Date of disclosure of the study information | 2014/07/14 |
| Last modified on | 2024/07/21 12:00:05 |
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Basic information
Public title
The relationship between physical activity level and arterial stiffness in chronic kidney disease patients
Acronym
Physical activity level and arterial stiffnes in CKD patients
Scientific Title
The relationship between physical activity level and arterial stiffness in chronic kidney disease patients
Scientific Title:Acronym
Physical activity level and arterial stiffnes in CKD patients
Region
| Japan |
Condition
Condition
CKD stage G3 or G4
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To investigate whether the arterial stiffness is related to physical activity level in chronic kidney disease patients
2) To investigate whether the change of renal function is related to physical performance in chronic kidney disease patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)pulse wave velosity
2)physical activity level
Key secondary outcomes
exercise tolerance
eGFR
muscle volume
muscle strength
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)CKD stage 3 or 4
2)Patients who are independent of ambulation and ADL
Key exclusion criteria
The person who are stopped exercising by his/her physician
The person who implanted a pace maker
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yamagata |
Organization
University of Tsukuba
Division name
Department of Nephrology
Zip code
3058576
Address
1-1-1 Ten-nodai,Tsukuba city, Ibaraki, Japan
TEL
0298532111
k-yamaga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Shiomi |
Organization
University of Tsukuba Hospital
Division name
Rehabilitation Medicine Service
Zip code
3058576
Address
2-1-1 Amakubo Tsukuba city, Ibaraki, Japan
TEL
0298533795
Homepage URL
shiomikohei@gmail.com
Sponsor or person
Institute
Department of Nephrology, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Tsukuba central 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
Tsukuba Clinical Research and Development Organization
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576 Japan
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
| 2014 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34342777/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34342777/
Number of participants that the trial has enrolled
147
Results
Study of 147 CKD patients showed positive correlation between Cre/CysC ratio and knee extensor muscle strength (KEMS). KEMS decreased with CKD progression. Higher Cre/CysC values had stronger correlation with KEMS. Findings suggest Cre/CysC as potential marker for physical function decline in CKD patients.
Results date posted
| 2024 | Year | 07 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients attending the outpatient department of nephrology at the University of Tsukuba Hospital were recruited. Inclusion criteria were creatinine-based estimated glomerular filtration rate (eGFRcreat) <60 mL/min/1.73 m2 and >=15 mL/min/1.73 m2, and independence in daily living.
Participant flow
The target participants were listed in advance from those who visited the outpatient clinic, and those who gave their consent were incorporated as participants after being approached during the outpatient clinic visit.
Adverse events
None.
Outcome measures
Serum creatinine concentration, serum cystatin C concentration, and KEMS, an index of lower limb muscle strength using a hand-held dynamometer, and skeletal muscle mass and body fat mass were assessed by bioelectrical impedance analysis. For statistical analysis, Pearson's correlation coefficient analysis was performed to verify the relationship between body composition and serum creatinine, serum cystatin C, and Cre/CysC. After examining the association between Cre/CysC and each measurement item using single regression analysis, multivariate linear regression analysis with forced entry method was used to examine the association between Cre/CysC and the significantly related items in the single regression analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate the effect of physical activity on inflamation marker, body composition, physical function, and quolity of life in chronic kidney disease patients.
Management information
Registered date
| 2014 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016663
