UMIN-CTR Clinical Trial

Basic information
Public title	Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Acronym	Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Scientific Title	Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Scientific Title:Acronym	Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Region	Japan

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

Objectives
Narrative objectives1	To examine the educational effects of exercise programs and brain activation programs for elderly people participating in community-based places of attendance.
Basic objectives2	Others
Basic objectives -Others	Consider factors that affect effectiveness.
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive function
Key secondary outcomes	1)Motor function. Grip strength, long-bend bend, 30 second chair standing up test, standing on one leg. 2)Comprehensive activity Life-Space Assessment, Falls Efficacy Scale, Bathing action, Continuous walking distance, Lubben Social Network Scale(LSNS-6) 3)Social capital indicators.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	One video gymnastics instruction for stretching and strength training. Video exercise for stretching and strength training 30 minutes,24 weeks of activity frequency at the place of attendance.
Interventions/Control_2	One instruction for video exercises for stretching and strength training, and two instructions for brain activation program. Video exercise for stretching and strength training 30 minutes + brain activation program 10 minutes through the activity frequency of the place for 24 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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	cluster 1)It is a communal place that municipalities judge to do gymnastics and hobbies, and to help prevent nursing care 2)Residents are responsible for managing the attendance 3)The management of commuting places is not limited to those where municipalities provide financial support 4)Have an activity record of at least once a month Individual unit 1)Those who are at risk or who are concerned about their health condition have obtained a doctor's consent form
Key exclusion criteria	cluster 1)A place for attendance of up to 7 participants Individual unit 1)Doctors determined that study participation is inappropriate 2)Those with cardiovascular, respiratory, neurological or orthopedic disorders that limit the performance of exercise and assessment 3)Persons with dysarthria or aphasia who cannot communicate 4)Those under 65 years old
Target sample size	58

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Sakata
Organization	Chizu hospital
Division name	Department of rehabilitation
Zip code	6891402
Address	1875 Chizu town,Tottori,Japan
TEL	0858-75-3211
Email	chiz@town.chizu.tottori.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Sakata
Organization	Chizu hospital
Division name	Department of rehabilitation
Zip code	6891402
Address	1875 Chizu town,Tottori,Japan
TEL	0858-75-3211
Homepage URL
Email	chiz@town.chizu.tottori.jp

Sponsor
Institute	Chizu hospital Department of rehabilitation
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research ethics committee of Japan Physical Therapy Association
Address	3-8-5 Sendagaya,Sibuya,Tokyo,Japan
Tel	03-6804-1626
Email	ethics@japanpt.or.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

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 09 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	0
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	2019 Year 08 Month 19 Day
Date of IRB	2019 Year 11 Month 29 Day
Anticipated trial start date	2019 Year 12 Month 02 Day
Last follow-up date	2020 Year 07 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 09 Day
Last modified on	2020 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043719