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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039336
Receipt No. R000044862
Scientific Title The exploratory study of analysis of expired gas during knee bending exercise combined with transcutaneous electrical stimulation in healthy subjects
Date of disclosure of the study information 2020/02/01
Last modified on 2020/02/03

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Basic information
Public title The exploratory study of analysis of expired gas during knee bending exercise combined with transcutaneous electrical stimulation in healthy subjects~development of countermeasures for muscle and bone atrophy~
Acronym The analysis of expired gas during knee bending exercise combined with transcutaneous electrical stimulation
Scientific Title The exploratory study of analysis of expired gas during knee bending exercise combined with transcutaneous electrical stimulation in healthy subjects
Scientific Title:Acronym The analysis of expired gas during knee bending exercise combined with transcutaneous electrical stimulation
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the change of metabolic function by the analysis of expired gas during knee bending exercise combined with transcutaneous electrical stimulation in healthy subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Oxygen intake
Key secondary outcomes Carbon dioxide excretion
Respiratory exchange ratio

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 One time, knee bending exercise with the lying position for 15 minutes
Interventions/Control_2 One time, Knee bending exercise combined with transcutaneous electrical stimulation with the lying position for 15 minutes
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
20 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Nonsmokers
Key exclusion criteria 1)Severe heart failure, renal failure, respiratory failure, cerebrovascular disease, other malignant disorder
2)Inflammatory disorder
3)Hard to exercise
4)Prohibited from exercise
5)The subject who a researcher employs
Target sample size 20

Research contact person
Name of lead principal investigator
1st name HIROO
Middle name
Last name MATSUSE
Organization Kurume University
Division name Division of Rehabilitation
Zip code 830-0011
Address Asahi-machi 67, Kurume, Fukuoka, Japan
TEL 0942353311
Email matsuse_hiroh@kurume-u.ac.jp

Public contact
Name of contact person
1st name HIROO
Middle name
Last name MATSUE
Organization Kurume University
Division name Division of Rehabilitation
Zip code 830-0011
Address Asahi-machi 67, Kurume, Fukuoka, Japan
TEL 0942353311
Homepage URL
Email matsuse_hiroh@kurume-u.ac.jp

Sponsor
Institute Kurume University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of Kurume University
Address Asahi-machi 67, Kurume, Fukuoka, Japan
Tel 0942653749
Email i_rinri@kurume-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

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 08 Month 01 Day
Date of IRB
2019 Year 12 Month 19 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2021 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 31 Day
Last modified on
2020 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044862

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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