UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of cognitive and physical training in older adults: A randomized control trial
Title of the study (Brief title)	Cognitive and physical training in older adults
Region	Japan

Condition
Condition	Older adults
Classification by specialty	Neurology Geriatrics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate effect of cognitive and physical training in older adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Timed Up and Go test Trail Making Test
Key secondary outcomes	Physical function: Grip strength, Short Physical Performance Battery, Muscle mass Cognitive function: Mini Mental State Examination, Rivermead Behavioral Memory Test story (immediate recall, delayed recall), Wechsler Memory Scale logical memory, Montreal Cognitive Assessment, Stroop test, Cognitive Assessment & Training Tool, Digit Symbol Substitution Test QOL: Sort Form-36

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	physical and cognitive intervention
Interventions/Control_2	No treatment control
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 70 years or older 2) Participants being able to come to Kobe university
Key exclusion criteria	1) Impairment in Basic Activity of daily living (Barthel Index<100) 2) Cognitive decline (Mini Mental State Examination<24) 3) Medically advised not to participate in exercise
Target sample size	54

Research contact person
Name of lead principal investigator	Hisatomo Kowa
Organization	Kobe University
Division name	Graduate School of Health Sciences
Address	7-10-2, Tomogaoka, Suma-ku, Kobe, Hyogo
TEL	078-796-4561
Email	kowa@med.kobe-u.ac.jp

Public contact
Name of contact person	Rei Ono
Organization	Kobe University
Division name	Graduate School of Health Sciences
Address	7-10-2, Tomogaoka, Suma-ku, Kobe, Hyogo
TEL	078-796-4545
Homepage URL
Email	ono@phoenix.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Life Science Institute, Inc Total Brain Care Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	神戸大学　名谷キャンパス

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 14 Day
Last follow-up date	2016 Year 12 Month 20 Day
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	2017 Year 06 Month 13 Day
Last modified on	2018 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031784