UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062493 |
|---|---|
| Receipt number | R000071530 |
| Scientific Title | A Prospective Study of the Effects of Intradialytic Exercise on alpha-Klotho,FGF23,Oxidative Stress, Vascular Function, and Physical Function in Patients Undergoing Maintenance Hemodialysis |
| Date of disclosure of the study information | 2026/08/06 |
| Last modified on | 2026/08/06 11:35:41 |
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Basic information
Public title
Study of the Effects of Intradialytic Exercise on Blood Biomarkers and Physical Function in Patients Undergoing Maintenance Hemodialysis
Acronym
KRX in Hemodialysis Study
Scientific Title
A Prospective Study of the Effects of Intradialytic Exercise on alpha-Klotho,FGF23,Oxidative Stress, Vascular Function, and Physical Function in Patients Undergoing Maintenance Hemodialysis
Scientific Title:Acronym
KRX Study
Region
| Japan |
Condition
Condition
Patients undergoing maintenance hemodialysis (chronic kidney disease stage G5D)
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this prospective study is to investigate the effects of intradialytic exercise on circulating alpha-Klotho, FGF23, oxidative stress, vascular function, and physical function in patients undergoing maintenance hemodialysis. The study also aims to clarify the association between exercise-induced alpha-Klotho responses and redox phenotype, thereby elucidating the biological mechanisms underlying exercise responsiveness and providing a scientific basis for individualized exercise therapy.
Basic objectives2
Others
Basic objectives -Others
Pathophysiology,Treatment
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in serum alpha-Klotho concentration after a 3-month intradialytic exercise program
Key secondary outcomes
Changes in serum FGF23 concentration, superoxide dismutase activity, radical scavenging activity, ankle to brachial index, echocardiographic parameters (e.g., ejection fraction and fractional shortening), physical function (e.g., handgrip strength and Short Physical Performance Battery), and their associations after the 3 month intradialytic exercise program.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will undergo a three month intradialytic exercise program. Aerobic exercise using a cycle ergometer will be performed during the first two hours of hemodialysis for 30 to 60 min per session, two to three times per week, at a Borg Rating of Perceived Exertion of 11 to 13. Exercise sessions will be supervised by a physical therapist, and exercise duration and workload will be adjusted according to each clinical condition and hemodynamic status.
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
| 50 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Patients undergoing maintenance hemodialysis three times per week for at least three months.
2 Clinically stable patients as judged by the attending nephrologist.
3 Patients capable of performing intradialytic exercise.
4 Patients who provided written informed consent.
Key exclusion criteria
1 Acute infection or inflammatory disease.
2 Unstable cardiovascular disease.
3 Severe orthopedic or neurological disorders limiting exercise participation.
4 Active malignancy.
5 Hospitalization within the previous three months.
6 Any condition judged by the attending physician to interfere with safe participation in the study.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | MISA |
| Middle name | |
| Last name | MIURA |
Organization
Tsukuba University of Technology
Division name
Health Sciences
Zip code
305-0821
Address
4-12-7 Kasuga Tsukuba,Ibaraki,305-8521 Japan
TEL
0298589552
m.miura@k.tsukuba-tech.ac.jp
Public contact
Name of contact person
| 1st name | MISA |
| Middle name | |
| Last name | MIURA |
Organization
Tsukuba University of Technology
Division name
Health Sciences
Zip code
305-8521
Address
4-12-7 Kasuga Tsukuba,Ibaraki,305-8521 Japan
TEL
0298589552
Homepage URL
m.miura@k.tsukuba-tech.ac.jp
Sponsor or person
Institute
Tsukuba University of Technology
Institute
Department
Personal name
Misa Miura
Funding Source
Organization
Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University of Technology
Address
4-12-7 Kasuga Tsukuba,Ibaraki,305-8521 Japan
Tel
+81298589552
m.miura@k.tsukuba-tech.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
あさおクリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 06 | 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
33
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Thirty-five participants were planned for enrollment. Thirty-three participants were enrolled, and all completed the 3-month intradialytic exercise program. Therefore, all 33 participants were included in the final analysis.
Adverse events
No serious adverse events related to the intradialytic exercise intervention were observed during the study.
Outcome measures
The primary outcome was the change in serum alpha-Klotho concentration after the 3 month intervention. Secondary outcomes included changes in FGF23, superoxide dismutase activity, radical scavenging activity, ankle to brachial index, echocardiographic parameters (e.g., ejection fraction and fractional shortening), physical function (e.g., handgrip strength and Short Physical Performance Battery), and their associations.
Plan to share IPD
De-identified data may be shared upon reasonable request after ethics approval for research purposes.
IPD sharing Plan description
De-identified participant data may be shared upon reasonable request after approval by the institutional ethics committee and the principal investigator.
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 01 | Day |
Other
Other related information
This study was conducted as a collaborative research project between Tsukuba University of Technology and Asao Clinic.
Management information
Registered date
| 2026 | Year | 08 | Month | 06 | Day |
Last modified on
| 2026 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071530
