臨床研究等提出・公開システム

Date of registration	Dec. 26, 2021
Last modified on	Jan. 11, 2022
Trial ID	jRCT1040210118

Scientific Title	Effect of exercise by wheelchair exercise equipment for frail elderly people
Public Title	Research on the effects of exercise equipment

Contact for Scientific Queries	Name	Isowa Tokiko
	Affiliation	Mie University
	Address	2-174 Edobashi, Tsu, Mie
	Telephone	+81-59-231-5258
	E-mail	tisowa@med.mie-u.ac.jp
Contact for Public Queries	Name	Isowa Tokiko
	Affiliation	Mie University
	Address	2-174 Edobashi, Tsu, Mie
	Telephone	+81-59-231-5258
	E-mail	tisowa@med.mie-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 26, 2021
Target sample size		7
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Elderly people aged 65 and over who use outpatient services Person who has received nursing care certification Elderly people with motor function training Persons who have obtained permission to participate in this study from a functional training instructor
	Exclusion Criteria	1) Those who are prohibited from training the lower limbs by a doctor 2) Those who cannot stand on their own 3) Those who have been diagnosed with dementia 4) Those who have difficulty understanding how to exercise 5) Those who cannot obtain consent
	Age Minimum	65age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Decreased walking ability
Intervention(s)		Pedaling and grasping exercises. Pedaling exercise consists of warming up, low load exercise, and cool down. The exercise time and break time are adjusted according to the degree of fatigue of the subject. The grasping movement is isometric.
Health Condition(s) Keyword		Frail
Intervention(s) Keyword		training
Primary Outcome(s)		The pedal rowing time is measured as the exercise duration, and the chair sitting time is measured 5 times as the leg strength.
Secondary Outcome(s)		Measure ADL and cognitive function.

Primary Sponsor	Tokiko Isowa

Secondary Sponsor

Name of Certified Review Board	Mie University Clinical Research Review Committee
Address	2-174 Edobashi, Tsu, Mie
Telephone	+81-59-231-5045
E-Mail	mie-crb@mo.medic.mie-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 03, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 11, 2022	(this page)	Changes
1	Dec. 26, 2021	Detail

List of change history