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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024682
Receipt No. R000028377
Scientific Title Effectiveness of community-wide promotion of physical activity in middle-aged and older adults: a dissemination study
Date of disclosure of the study information 2016/11/02
Last modified on 2017/02/08

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Basic information
Public title Effectiveness of community-wide promotion of physical activity in middle-aged and older adults: a dissemination study
Acronym Effectiveness of community-wide promotion of physical activity in middle-aged and older adults: a dissemination study
Scientific Title Effectiveness of community-wide promotion of physical activity in middle-aged and older adults: a dissemination study
Scientific Title:Acronym Effectiveness of community-wide promotion of physical activity in middle-aged and older adults: a dissemination study
Region
Japan

Condition
Condition Physical inactivity and musculoskeletal pain
Classification by specialty
Medicine in general Geriatrics Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effectiveness of community-wide intervention for increasing physical activity and reducing musculoskeletal pain in middle-aged and older adults. This study is a dissemination study of the previous cluster randomized trial which started in 2009 (UMIN000002683; UMIN000012464). This study extends the area of the intervention to the whole city and examines its effectiveness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in the engagement in regular aerobic, flexibility, and/or muscle-strengthening activities from baseline to 5-year follow-up
Key secondary outcomes Changes in each of the different activities (aerobic, flexibility, and muscle-strengthening activities), VAS (Visual Analogue Scale) pain scores and chronic pains of low back and knee from baseline to 5-year follow-up, certification of needed long-term care, and mortality

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 For 5 years, a community-wide intervention (information, education, and support delivery etc.) is implemented to promote aerobic, flexibility, and/or muscle-strengthening activities in the intervention area.
Interventions/Control_2
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
40 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria Middle-aged and older adults living in the study area
Key exclusion criteria Those in assisted living facilities and those who require nursing care
Target sample size 2760

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun kitayuguchi
Organization Physical Education and Medicine Research Center UNNAN
Division name Research Division
Zip code
Address 328 Uji, Kamo Town, Unnan City, Shimane Prefecture, 699-1105, Japan
TEL 0854-49-9050
Email junk_907@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun kitayuguchi
Organization Physical Education and Medicine Research Center UNNAN
Division name Research Division
Zip code
Address 328 Uji, Kamo Town, Unnan City, Shimane Prefecture, 699-1105, Japan
TEL 0854-49-9050
Homepage URL
Email shintai@bs.kkm.ne.jp

Sponsor
Institute Physical Education and Medicine Research Center UNNAN
Institute
Department

Funding Source
Organization Japanese Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 02 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 No longer recruiting
Date of protocol fixation
2016 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 03 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 08 Month 31 Day
Date analysis concluded
2022 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 02 Day
Last modified on
2017 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028377

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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