UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059737 |
|---|---|
| Receipt number | R000068312 |
| Scientific Title | A Clinical Study on the Correlation Between Exercise Intensities Corresponding to the Anaerobic Threshold (AT) Measured by the Standard Cardiopulmonary Exercise Testing Using Respiratory Gas Analysis and the Oxygen Saturation Threshold (ST) Measured by the Novel S-Slope Method in Patients with Chronic Kidney Disease |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2026/02/01 18:42:15 |
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Basic information
Public title
A Clinical Study on the Correlation Between Exercise Intensities Corresponding to the Anaerobic Threshold (AT) Measured by the Standard Cardiopulmonary Exercise Testing Using Respiratory Gas Analysis and the Oxygen Saturation Threshold (ST) Measured by the Novel S-Slope Method in Patients with Chronic Kidney Disease
Acronym
A Clinical Study of the Anaerobic Threshold (AT) and the Oxygen Saturation Threshold (ST) Determined by Cardiopulmonary Exercise Testing in Patients with Chronic Kidney Disease
Scientific Title
A Clinical Study on the Correlation Between Exercise Intensities Corresponding to the Anaerobic Threshold (AT) Measured by the Standard Cardiopulmonary Exercise Testing Using Respiratory Gas Analysis and the Oxygen Saturation Threshold (ST) Measured by the Novel S-Slope Method in Patients with Chronic Kidney Disease
Scientific Title:Acronym
A Clinical Study of the Anaerobic Threshold (AT) and the Oxygen Saturation Threshold (ST) Determined by Cardiopulmonary Exercise Testing in Patients with Chronic Kidney Disease
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between exercise intensity at the anaerobic threshold (AT) using the "exhaled gas analysis method," a standard measurement method for cardiopulmonary exercise stress testing, and exercise intensity corresponding to the oxygen saturation threshold (ST) using the "S-Slope method," in patients with chronic kidney disease (CKD), and to examine whether ST can be used as a substitute for AT in CKD patients.
Basic objectives2
Others
Basic objectives -Others
To examine the correlation between exercise intensity corresponding to the indices (AT and ST) obtained using two measurement methods.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between exercise intensity corresponding to AT defined by heart rate and that corresponding to ST defined by pulse rate (PR)
Key secondary outcomes
Correlation between other exercise intensities corresponding to AT and ST defined as watt and VO2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with chronic kidney disease (CKD)
2) Patients appropriate for exercise therapy
3) Patients aged between 20 and 80 years
4) Patients who have provided written informed consent
Key exclusion criteria
1) Patients who have intolerance to high-intensity exercise
2) Patients with exercise-induced disorders such as exercise-induced arrhythmia or exercise-induced anaphylaxis, or those with musculoskeletal impairments that limit exercise
3) Patients who wish to become pregnant during the study period, and pregnant or breastfeeding woman
4) Patients who are participating in, or are scheduled to participate in another clinical study
5) Any other patients deemed inappropriate for participation in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | KAWASAKI |
Organization
Kohokai Medical Corporation, Sugamo Kidney Clinic
Division name
Chairman / Director
Zip code
170-0002
Address
Sugamo Toho Building 8th Floors, 1-18-8 Sugamo, Toshima-ku, Tokyo, Japan
TEL
03-6902-3880
mk@shioyakai.com
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | KAWASAKI |
Organization
Kohokai Medical Corporation, Sugamo Kidney Clinic
Division name
Chairman / Director
Zip code
170-0002
Address
Sugamo Toho Building 8th Floors, 1-18-8 Sugamo, Toshima-ku, Tokyo, Japan
TEL
03-6902-3880
Homepage URL
mk@shioyakai.com
Sponsor or person
Institute
Kohokai Medical Corporation, Sugamo Kidney Clinic
Institute
Department
Personal name
Funding Source
Organization
FANCL CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo, Ethical Review Committee
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, JAPAN
Tel
03-5803-4547
rinri.adm@tmd.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
医療法人湖歩会 すがも腎クリニック（東京都）
株式会社ファンケル（神奈川県）
東京科学大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the correlation between exercise intensity corresponding to the indices (AT and ST) obtained using two measurement methods.
Management information
Registered date
| 2025 | Year | 11 | Month | 11 | Day |
Last modified on
| 2026 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068312
