UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026189 |
|---|---|
| Receipt number | R000030057 |
| Scientific Title | Skeletal muscle oxygenation during cycling |
| Date of disclosure of the study information | 2017/04/15 |
| Last modified on | 2025/03/09 13:16:46 |
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Basic information
Public title
Skeletal muscle oxygenation during cycling
Acronym
Skeletal muscle oxygenation during cycling
Scientific Title
Skeletal muscle oxygenation during cycling
Scientific Title:Acronym
Skeletal muscle oxygenation during cycling
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of different pedaling rate and exercise intensity during cycle ergometer exercise on the skeletal muscle oxygenation level determined by near-infrared spectroscopy (NIRS), cardio-respiratory responses and degree of psychological burden.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
Change of muscle oxygenation level in the active muscles obtained by oxy-hemoglobin, deoxy-hemoglobin and total hemoglobin during cycle exercise
Key secondary outcomes
Change of respiratory response (oxygen uptake, minute ventilation, breathing frequency), circulatory response (heart rate, blood pressure), metabolic function (blood lactate concentration) and psychological burden (rate of perceived exertion) during cycling
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
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Exercise intensity is adjusted to participant's ventilatory threshold (VT) level. Revolution rate changes from 110rev/min to 90rev/min, 70rev/min, 50rev/min, 30rev/min. Each trial contains 5min exercise and 8min rest. Thereafter, exercise intensity is changed to 70% of VT and the order of revolution rate is the same as before.
Interventions/Control_2
Exercise intensity is adjusted to participant's ventilatory threshold (VT) level. Revolution rate changes from 30rev/min to 50rev/min, 70rev/min, 90rev/min, 110rev/min. Each trial contains 5min exercise and 8min rest. Thereafter, exercise intensity is changed to 70% of VT and the order of revolution rate is the same as before.
Interventions/Control_3
Exercise intensity is adjusted to participant's 70% of ventilatory threshold (VT) . Revolution rate changes from 110rev/min to 90rev/min, 70rev/min, 50rev/min, 30rev/min. Each trial contains 5min exercise and 8min rest. Thereafter, exercise intensity is changed to VT level and the order of revolution rate is the same as before.
Interventions/Control_4
Exercise intensity is adjusted to participant's 70% of ventilatory threshold (VT) . Revolution rate changes from 30rev/min to 50rev/min, 70rev/min, 90rev/min, 110rev/min. Each trial contains 5min exercise and 8min rest. Thereafter, exercise intensity is changed to VT level and the order of revolution rate is the same as before.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
Smoker, patients of circulatory or respiratory or metabolic disease
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Ishida |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
E5-2(130), Furo-cho, Chikusa-ku, Nagoya 46 4-8601, JAPAN
TEL
052-788-6258
ishida@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Ishida |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
E5-2(130), Furo-cho, Chikusa-ku, Nagoya 46 4-8601, JAPAN
TEL
052-788-6258
Homepage URL
ishida@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Exercise and Sports Physiology, Graduate School of Medicine, Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nagoya City University
King's College London
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Nagoya University Graduate School of Medicine
Address
65, Tsurumai, Showa-ku, Nagoya
Tel
052-744-2479
ethics@med.nagoya-u.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
名古屋大学 総合保健体育科学センター（愛知県）
Research Center of Health, Physical Fitness and Sports, Nagoya University, Aichi, Japan
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
not related
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1055/a-0835-6286
Number of participants that the trial has enrolled
47
Results
At 100%VT work load, 90rpm should be harder to pedal, while 40rpm should be similar burden as popular used cadence (50 - 60 rpm) although the exerted muscle force is high. 90rpm is less energetically efficient and should compromise skeletal muscle oxygenation.
Results date posted
| 2025 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy young people
Participant flow
Use of the university's subject recruitment system
Adverse events
nothing
Outcome measures
Ventilation, Respiratory rate, Heart rate, Cognitive test (TMT), cadences
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
The sample size is limited because this study is conducted as the pilot experiments for the regular main experiments in UK. Accordingly, the No. of arms for intervention is set at 4 because of the small sample size. Fundamentally, No of revolution rate is 5 and No. of exercise intensity is 2 so that all conditions should be (5*4*3*2*1)*2 cases. This is too large so we made the order of revolution rate not random but 2 order case, incremental or decremental order. Totally, No of arms becomes 2 revolution rate multiplied by 2 exercise intensity equals 4 cases.
Management information
Registered date
| 2017 | Year | 02 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030057
