UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063276 |
|---|---|
| Receipt number | R000072430 |
| Scientific Title | Positional relationship between the onset of the stroke volume plateau and indices for exercise intensity prescription during incremental exercise testing |
| Date of disclosure of the study information | 2026/10/14 |
| Last modified on | 2026/10/14 17:01:22 |
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Basic information
Public title
Positional relationship between the onset of the stroke volume plateau and indices for exercise intensity prescription during incremental exercise testing
Acronym
Positional relationship between the onset of the stroke volume plateau and indices for exercise intensity prescription during incremental exercise testing
Scientific Title
Positional relationship between the onset of the stroke volume plateau and indices for exercise intensity prescription during incremental exercise testing
Scientific Title:Acronym
Positional relationship between the onset of the stroke volume plateau and indices for exercise intensity prescription during incremental exercise testing
Region
| Japan |
Condition
Condition
Cardiovascular diseases for which aerobic exercise is prescribed in cardiac rehabilitation (particularly heart failure with preserved ejection fraction, HFpEF)
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify, by within-participant comparison, where the point at which stroke volume (SV) reaches a plateau (SV plateau onset) lies relative to clinically used indices for exercise intensity prescription (anaerobic threshold [AT], the point of reaching the target heart rate by the Karvonen method, and the point of reaching 15 on the original Borg scale) during a single symptom-limited incremental exercise test in healthy young men.
Hypothesis: The work rate at SV plateau onset does not coincide with that at AT, and the points of reaching the Karvonen target heart rate and Borg scale 15 are located at higher work rates than SV plateau onset.
Basic objectives2
Others
Basic objectives -Others
Description and comparison of the positional relationship between SV plateau onset and existing indices for exercise intensity prescription (exercise physiology study)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Work rate (W) at each of the following points: (1) SV plateau onset, (2) anaerobic threshold (AT), (3) the point of reaching the target heart rate by the Karvonen method (estimated maximal heart rate = 220 - age, k = 0.6), and (4) the point of reaching 15 on the original Borg scale for leg fatigue.
SV plateau onset is defined as the breakpoint estimated by piecewise linear regression of 30-second averaged beat-by-beat SV (thoracic impedance cardiography) against work rate. AT is determined mainly by the V-slope method.
Timing: identified post hoc from continuous data recorded during a single incremental exercise test on the measurement day.
Key secondary outcomes
(1) SV, stroke volume index (SVI), cardiac index (CI), heart rate, oxygen uptake (VO2), %peak VO2, and original Borg scale at each point
(2) Peak values: peak VO2, peak HR, peak work rate, and peak SV
(3) Proportion of participants in whom an SV plateau is identified, and %peak VO2 at SV plateau onset
(4) Inter-rater agreement for SV plateau onset and AT (ICC(2,1)), and agreement between SV plateau onset and AT (Bland-Altman analysis)
(5) Sensitivity analyses: SV plateau onset by an alternative definition (the first point at which the SV increase is less than 5% of the preceding interval in two consecutive 30-second intervals), the Karvonen point using measured peak heart rate, and the points for k = 0.5 and k = 0.7
Timing: all assessed during the single exercise test on the measurement day.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
A single symptom-limited incremental exercise test on an electromagnetically braked cycle ergometer (Corival V2, Lode).
Protocol: after 5 min of seated rest, a 3-min warm-up (0-10 W, 50-60 rpm) is followed by a ramp increment of 20 W/min (adjusted to 15 or 25 W/min according to exercise habits and body size) up to symptom-limited maximum (participant's request to stop or inability to maintain 50 rpm for 10 s or longer), then 3 min of unloaded pedaling and at least 15 min of recovery observation.
Measurements: breath-by-breath expired gas analysis (AE-310S, Minato Medical Science), continuous SV by thoracic impedance cardiography (PhysioFlow Q-Link), continuous ECG monitoring (STS-2100, Nihon Kohden), blood pressure every 2 min (Tango M2, SunTech Medical), and original Borg scale for leg fatigue and dyspnea every minute. Body composition (InBody770), resting blood pressure, and a 12-lead ECG are obtained beforehand for screening.
Duration/frequency: once, on one measurement day (about 120 min). The explanation session (about 30 min) is held on a separate day.
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male
Key inclusion criteria
(1) Healthy male students enrolled at the Narita Campus of the International University of Health and Welfare
(2) Aged 18 years or older and younger than 25 years at the time of consent
(3) Able to provide written informed consent of their own free will
Key exclusion criteria
(1) History of, or current treatment for, heart disease, respiratory disease, hypertension, diabetes, or other chronic diseases
(2) Resting blood pressure of 140/90 mmHg or higher, or resting 12-lead ECG findings judged inappropriate for exercise testing
(3) Current smokers or those who smoked within the past year
(4) Lower-limb injury or orthopedic disorder within the past 6 months that makes cycle ergometer exercise difficult
(5) Regular use of medications affecting hemodynamics
(6) Currently competing in endurance sports at the national level or higher
(7) Students in the graduation research seminar supervised by the principal investigator
(8) On the measurement day, failure to follow the pre-test conditions (no alcohol or strenuous exercise for 24 h, no caffeine or meals for 3 h before testing) or complaints of feeling unwell (re-scheduling the measurement is allowed)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinta |
| Middle name | |
| Last name | Takeuchi |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita, Chiba 286-8686, Japan
TEL
0476-20-7746
shinta.t@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shinta |
| Middle name | |
| Last name | Takeuchi |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita, Chiba 286-8686, Japan
TEL
0476-20-7746
Homepage URL
shinta.t@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Shinta Takeuchi
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS 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
Chiba Area Ethics Committee, International University of Health and Welfare
Address
Chiba Area Ethics Committee Office, International University of Health and Welfare, Narita Campus, 4-3 Kozunomori, Narita, Chiba 286-8686, Japan
Tel
0476-20-7708
rinri_md@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
| 2026 | Year | 10 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 10 | Month | 14 | Day |
Last modified on
| 2026 | 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=R000072430
