UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060453 |
|---|---|
| Receipt number | R000069168 |
| Scientific Title | Analysis of lower limb muscle oxygenation kinetics during upper limb exercise in wheelchair users |
| Date of disclosure of the study information | 2026/01/23 |
| Last modified on | 2026/01/23 17:47:15 |
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Basic information
Public title
Analysis of lower limb muscle oxygenation kinetics during upper limb exercise in wheelchair users
Acronym
Analysis of lower limb muscle oxygenation kinetics during upper limb exercise in wheelchair users
Scientific Title
Analysis of lower limb muscle oxygenation kinetics during upper limb exercise in wheelchair users
Scientific Title:Acronym
Analysis of lower limb muscle oxygenation kinetics during upper limb exercise in wheelchair users
Region
| Japan |
Condition
Condition
Spinal cord injury, Spina bifida, Lower limb amputation, Healthy participants
Classification by specialty
| Orthopedics | Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the characteristics of circulatory and metabolic responses in relation to impairment type and neurological level in wheelchair users (specifically individuals with spinal cord injury, spina bifida, and lower limb amputation) by measuring lower limb muscle oxygenation kinetics during upper limb exercise using NIRS.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in lower limb muscle oxygenation kinetics during upper limb exercise testing
Key secondary outcomes
Muscle oxygenation kinetics, Cerebral oxygenation kinetics, Hemodynamic parameters, Respiratory gas analysis, Exercise tolerance indices, Physical characteristics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
Wheelchair User Group
Adult males who are habitual wheelchair users due to conditions such as spinal cord injury (cervical or thoracolumbar), spina bifida, or lower limb amputation.
Individuals capable of safely performing voluntary exercise using an upper limb ergometer.
Individuals who demonstrated a full understanding of participation in this study and provided written informed consent.
Healthy Control Group
Healthy males matched to the wheelchair user group for age and sex.
Individuals with no history of neurological or orthopedic disorders affecting lower limb motor function.
Individuals who demonstrated a full understanding of participation in this study and provided written informed consent.
Key exclusion criteria
Individuals with acute or uncontrolled cardiovascular diseases (e.g., heart failure, arrhythmia, angina pectoris).
Individuals with severe respiratory diseases.
Individuals with marked autonomic dysfunction presenting a high risk of exercise-induced hypotension or syncope.
Individuals unable to safely perform arm crank exercise due to severe contracture, pain, or orthopedic disorders in the upper limbs.
Individuals unable to understand the study, provide informed consent, or adhere to instructions due to cognitive impairment or psychiatric disorders.
Individuals deemed unsuitable for participation by a physician for safety reasons.
Target sample size
75
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
| 2030 | Year | 05 | 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 | 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=R000069168
