UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of muscle endurance test of lower limb muscle by rise motion and relation of cardiorespiratory endurance
Title of the study (Brief title)	Development of muscle endurance test of lower limb muscle by rise motion and relation of cardiorespiratory endurance
Region	Japan

Condition
Condition	healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop an endurance test in which the load on the whole body is small and the load on the lower extremity is selectively applied
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	oxygen consumption carbon dioxide output heart rate, stroke volume cardiac output Tissue oxygen saturation Oxygen saturation systolic blood pressure
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Cardiopulmonary exercise load test, rise test possible
Key exclusion criteria	A parson with a history of pulmonary disease Smoker
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroaki Takada
Organization	Kio University
Division name	Division of Health Science, Graduate School of Health Science
Address	4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL	0745-54-1602
Email	hiroaki_t_hy@yahoo.co.jp

Public contact
Name of contact person	Hiroaki Takada
Organization	Kio University
Division name	Division of Health Science, Graduate School of Health Science
Address	4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL	0745-54-1602
Homepage URL
Email	hiroaki_t_hy@yahoo.co.jp

Sponsor
Institute	Kio University
Institute
Department

Funding Source
Organization	Kio University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	畿央大学（奈良県）

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 06 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 06 Day
Anticipated trial start date	2018 Year 05 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	I think that it is a material for grasping the aerobic ability of skeletal muscle as a limiting factor with decreased exercise tolerance and to judge the priority order as a therapeutic approach of physical therapy.

Management information
Registered date	2018 Year 04 Month 06 Day
Last modified on	2018 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036667