UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048322 |
|---|---|
| Receipt number | R000055073 |
| Scientific Title | Effect of carbohydrate intake on competitive performance and substrate oxidation of people with spinal cord injury |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2025/01/09 09:27:33 |
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Basic information
Public title
Effect of carbohydrate intake on competitive performance and substrate oxidation of people with spinal cord injury
Acronym
Effect of carbohydrate intake on competitive performance and substrate oxidation of people with spinal cord injury
Scientific Title
Effect of carbohydrate intake on competitive performance and substrate oxidation of people with spinal cord injury
Scientific Title:Acronym
Effect of carbohydrate intake on competitive performance and substrate oxidation of people with spinal cord injury
Region
| Japan |
Condition
Condition
Spinal cord injury
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of carbohydrate intake on competitive performance and substrate oxidation of people with spinal cord injury who use manual wheelchair on the daily basis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Exercise duration
Key secondary outcomes
peak oxygen uptake, maximal fat oxidation rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
8% concentration carbohydrate drink 500ml
Interventions/Control_2
Exercise test using arm-crank ergometer
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Active para-athletes
2. People with spinal cord injury (incl. spina bifida)
3. 18-69 years
In case of healthy participants,
18-69 years
Key exclusion criteria
1. People who can not exercise on arm-crank ergometer according to the paralysis level of C6 or higher
2. People with disability except for physical disability (ex. people with visual, hearing or intellectual impairment) or with internal disease
3. People who is judged by the medical docter to have difficulty in receiving exercise test
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
0666052947
yokoyama_hisayo@omu.ac.jp
Public contact
Name of contact person
| 1st name | Hisayo |
| Middle name | |
| Last name | Yokoyama |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Environmental Physiology for Exercise
Zip code
558-8585
Address
3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL
0666052947
Homepage URL
yokoyama_hisayo@omu.ac.jp
Sponsor or person
Institute
Environmental Physiology for Exercise, Osaka Metropolitan University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kansai University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Osaka Metropolitan University Graduate School of Medicine
Address
1-2-7, Asahi-Machi, Abeno-ku, Osaka
Tel
0666453456
gr-a-knky-ethics@omu.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
| 2022 | Year | 09 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055073
