臨床研究等提出・公開システム

Date of registration	Jan. 28, 2025
Last modified on	Jan. 28, 2025
Trial ID	jRCT1040240175

Scientific Title	Intervention study for social implementation of comprehensive frailty control for the elderly in the community
Public Title	Anti-Frail Implementation Study

Contact for Scientific Queries	Name	Isowa Tokiko
	Affiliation	Mie University
	Address	2-174 Edobashi, Tsu, Mie, Japan
	Telephone	+81-592315258
	E-mail	tisowa@med.mie-u.ac.jp
Contact for Public Queries	Name	Tokiko Isowa
	Affiliation	Mie University
	Address	2-174 Edobashi, Tsu, Mie, Japan
	Telephone	+81-592315258
	E-mail	tisowa@med.mie-u.ac.jp

Recruitment status	Pending


Anticipated date of first enrollment		Jan. 28, 2025
Target sample size		60
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 persons aged 65 years or older residing in the community Have given their free written consent to participate in this study
	Exclusion Criteria	Persons who are prohibited by a physician from lower limb training Persons who have been diagnosed with dementia Persons who are deemed inappropriate as research subjects by the principal investigator.
	Age Minimum	65age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Pre-frail and frail
Intervention(s)		Regular eccentric exercise and lectures and activities for interaction among participants
Health Condition(s) Keyword		Frail
Intervention(s) Keyword		training
Primary Outcome(s)		frailty index
Secondary Outcome(s)		Exercise duration, 5 times chair standing time, balance function, cognitive function, motivation

Primary Sponsor	Tokiko Isowa

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

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none