UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study of exercise for care prevention
Acronym	Effects of the exercise for care prevention
Scientific Title	Intervention study of exercise for care prevention
Scientific Title:Acronym	Effects of the exercise for care prevention
Region	Japan

Condition
Condition	Elderly people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Care prevention
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Lower extremity muscle strength
Key secondary outcomes	Balance function Gait speed Cognitive function Quality of life

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment Behavior,custom Maneuver Other
Interventions/Control_1	They will perform Square-stepping exercise 3 times per week for 12 weeks
Interventions/Control_2	They will perform Square-stepping exercise combined with Neuromusclar electrical stimulation3 times per week for 12 weeks
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	60 years-old <=
Age-upper limit	95 years-old >
Gender	Male and Female
Key inclusion criteria	Independence of gait by oneself
Key exclusion criteria	1) Contraindication of the electrical stimulation. 2) Not being able to walk more than 50m. 3) Not being able to do any exercise. 4) Contraindication of any exercise.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hiroo Middle name Last name Matsuse
Organization	Kurume University
Division name	Department of rehabilitation
Zip code	8300011
Address	67 asahi-machi, Kurume city, Fukuka, Japan
TEL	0942317568
Email	matsuse_hiroh@kurume-u.ac.jp

Public contact
Name of contact person	1st name Hiroo Middle name Last name Matsuse
Organization	Department of rehabilitation
Division name	67 asahi-machi, Kurume city, Fukuka, Japan
Zip code	8300011
Address	+81942317568
TEL	0942317568
Homepage URL
Email	matsuse_hiroh@kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

Funding Source
Organization	Department of rehabilitation, Kurume university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Review Board of Kurume University
Address	67, asahi-machi, Kurume city, Fukuoka, Japan
Tel	0942317917
Email	sangaku@kurume-u.ac.jp

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	久留米大学病院

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 11 Month 10 Day
Date of IRB	2018 Year 05 Month 14 Day
Anticipated trial start date	2018 Year 05 Month 18 Day
Last follow-up date	2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 25 Day
Last modified on	2021 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034887