臨床研究等提出・公開システム

Date of registration	Jan. 05, 2022
Last modified on	Jan. 05, 2022
Trial ID	jRCT1032210536

Scientific Title	Pedaling Exercise Load System for Mobility for Elderly
Public Title	Pedaling Exercise Load System for Mobility for Elderly

Contact for Scientific Queries	Name	Yusuke Sugahara
	Affiliation	Tokyo Institute of Technology
	Address	2-12-1 Ookayama, Meguro-ku, Tokyo (I6-15)
	Telephone	+81-3-5734-2927
	E-mail	sugahara.y.ab@m.titech.ac.jp
Contact for Public Queries	Name	Tatsuya Yagi
	Affiliation	Tokyo Institute of Technology
	Address	2-12-1 Ookayama, Meguro-ku, Tokyo (I6-15)
	Telephone	+81-3-5734-2927
	E-mail	sugahara.y.ab@m.titech.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 05, 2022
Target sample size		20
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Adult healthy men and women between the ages of 20 and 60
	Exclusion Criteria	(1) If you have a serious chronic illness. (2) If you have an injury or illness for which treatment and rehabilitation have not been completed. (3) If you are pregnant or may become pregnant. (4) Elderly or disabled people (5) If you plans to engage in sports with excessive exercise intensity during the period. (6) If the practitioner judges that you are not suitable for the experiment.
	Age Minimum	20age 0month 0week old over
	Age Maximum	60age 0month 0week old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Improvement of physical functions
Intervention(s)		intervention group -8 months of regular pedaling exercise non-intervention group -none
Primary Outcome(s)		-maximal muscle strength test, surface EMG measurement during pedaling -joint angle and surface EMG measurement during walking -open-eyed one-legged standing time -FRT -10 m walking test

Primary Sponsor	Yusuke Sugahara

Source of Monetary Support	Grant-in-Aid for Scientific Research
Secondary Sponsor	Not applicable

Name of Certified Review Board	Human Subjects Research Ethics Review Committee
Address	General Affairs and Management Group, Research Planning Division, Research Promotion Department, Tokyo Institute of Technology 2-12-1 Ookayama, Meguro-ku, Tokyo
Telephone	+81-3-5734-3808
E-Mail	hitorinri@jim.titech.ac.jp
Approval Status	Approval
Date of approval	Oct. 26, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none