UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Health promotion effect of group programs specialized in enabling life performance for the Comprehensive Daily Living Support elderly
Title of the study (Brief title)	Health promotion effect of group programs for the Comprehensive Daily Living Support elderly
Region	Japan

Condition
Condition	Frail elderly people
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this research is to verify whether the improving life performance and health promotion effects can be expected, when group programs focusing on the enabling life performance are implemented for the Comprehensive Daily Living Support elderly, compared with group programs focusing on physical and mental functions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Goal Attainment Scale light WHO/QOL26 Life Satisfaction Index Grip strength, 5-m walking time, time and a timed up & go
Key secondary outcomes	Tokyo Metropolitan Institute of Gerontorogy Index of Competence

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Intervention group: Programs focusing on life performance (composed of two stages of learning group and group work)
Interventions/Control_2	Control group: Programs focusing on practical skills such as improving functions of exercisers prevention of cognitive deterioration
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	65 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) the Comprehensive Daily Living Support elderly from 65 to 85 years old 2) Those who can come to the program implementation site on their own or can attend family attendance
Key exclusion criteria	1) Those who can not visit the program implementation site 2) Those who can not understand the contents of the research 3) Those who can not show their intention to cooperate on their own
Target sample size	64

Research contact person
Name of lead principal investigator	Kenichiro Furuta
Organization	Tokyo Metroporitan University
Division name	Master Course, Department of Occupational Therapy, Graduate School of Human Health Sciences
Address	7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL	03-3819-1211
Email	furuta-kenichiro@ed.tmu.ac.jp

Public contact
Name of contact person	Kenichiro Furuta
Organization	Tokyo Metroporitan University
Division name	Master Course, Department of Occupational Therapy, Graduate School of Human Health Sciences
Address	7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL	03-3819-1211
Homepage URL
Email	furuta-kenichiro@ed.tmu.ac.jp

Sponsor
Institute	Tokyo Metroporitan University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 18 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 03 Month 31 Day
Anticipated trial start date	2018 Year 04 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 18 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036843