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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026189
Receipt No. R000030057
Scientific Title Skeletal muscle oxygenation during cycling
Date of disclosure of the study information 2017/04/15
Last modified on 2019/03/10

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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
Middle name
Last name Koji Ishida
Organization Nagoya University
Division name Research Center of Health, Physical Fitness and Sports
Zip code
Address E5-2(130), Furo-cho, Chikusa-ku, Nagoya 46 4-8601, JAPAN
TEL 052-788-6258
Email ishida@htc.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Ishida
Organization Nagoya University
Division name Research Center of Health, Physical Fitness and Sports
Zip code
Address E5-2(130), Furo-cho, Chikusa-ku, Nagoya 46 4-8601, JAPAN
TEL 052-788-6258
Homepage URL
Email ishida@htc.nagoya-u.ac.jp

Sponsor
Institute Exercise and Sports Physiology, Graduate School of Medicine, Nagoya University
Institute
Department

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
Address
Tel
Email

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
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
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
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 Completed
Date of protocol fixation
2017 Year 04 Month 20 Day
Date of IRB
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
2019 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030057

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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