UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060450 |
|---|---|
| Receipt number | R000069159 |
| Scientific Title | Comparison of Physiological Responses to Constant Load Exercise at Ventilatory Threshold Intensity and High-Intensity Interval Exercise During Wheelchair Propulsion |
| Date of disclosure of the study information | 2026/01/23 |
| Last modified on | 2026/01/23 16:27:57 |
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Basic information
Public title
Comparison of Physiological Responses to Constant Load Exercise at Ventilatory Threshold Intensity and High-Intensity Interval Exercise During Wheelchair Propulsion
Acronym
Comparison of Physiological Responses to Constant Load Exercise at Ventilatory Threshold Intensity and High-Intensity Interval Exercise During Wheelchair Propulsion
Scientific Title
Comparison of Physiological Responses to Constant Load Exercise at Ventilatory Threshold Intensity and High-Intensity Interval Exercise During Wheelchair Propulsion
Scientific Title:Acronym
Comparison of Physiological Responses to Constant Load Exercise at Ventilatory Threshold Intensity and High-Intensity Interval Exercise During Wheelchair Propulsion
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the physiological characteristics associated with different exercise modalities during wheelchair propulsion. To achieve this, we compared steady-state exercise and high-intensity interval exercise by comprehensively analyzing the time-series changes in upper and lower limb muscle oxygenation, PFC cerebral oxygenation, cardiac output, respiratory metabolism, and muscle activity.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in lower limb muscle oxygenation during wheelchair propulsion
Key secondary outcomes
Muscle oxygenation kinetics, Cerebral oxygenation kinetics, Hemodynamic parameters, Respiratory gas analysis, Surface electromyography, Exercise tolerance indices, Physical characteristics
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Cardiopulmonary exercise testing
Interventions/Control_2
Wheelchair propulsion exercise
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Healthy males aged 18 years or older
2. No history of orthopedic disorders in the upper or lower limbs that would interfere with exercise
3. No history of cardiopulmonary or neurological diseases
4. Individuals who provided written informed consent after receiving a full explanation of the study's purpose and procedures
Key exclusion criteria
1. History of cardiovascular disease (e.g., arrhythmia, heart failure, severe hypertension)
2. History of respiratory disease (e.g., asthma, chronic respiratory failure)
3. Acute or chronic orthopedic pain or disorders that limit exercise performance
4. Difficulty attaching electrodes or sensors due to dermatological conditions or skin allergies
5. Initiation of a new high-intensity exercise training regimen during the study period
6. Individuals deemed by the investigator to be unable to participate safely
7. Principal investigator or co-investigators of the present study
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Endo |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy
Zip code
960-8516
Address
10-6, Sakaemachi, Fukushima City, Japan
TEL
024-581-5539
ysendo@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Endo |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy
Zip code
960-8516
Address
10-6, Sakaemachi, Fukushima City, Japan
TEL
024-581-5539
Homepage URL
ysendo@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikariga-oka, Fukushima City 960-1295, JAPAN
Tel
024-547-1825
rs@fmu.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
福島県立医科大学（福島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 23 | 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
| 2026 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 30 | 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 | 01 | Month | 23 | Day |
Last modified on
| 2026 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069159
