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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012464
Receipt No. R000014564
Scientific Title Effectiveness of community-wide promotion of physical activity in middle-aged and elderly people: a 5-year extended study of a cluster RCT
Date of disclosure of the study information 2013/12/02
Last modified on 2018/01/11

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Basic information
Public title Effectiveness of community-wide promotion of physical activity in middle-aged and elderly people: a 5-year extended study of a cluster RCT
Acronym Effectiveness of community-wide promotion of physical activity: a 5-year extended study of a cluster RCT
Scientific Title Effectiveness of community-wide promotion of physical activity in middle-aged and elderly people: a 5-year extended study of a cluster RCT
Scientific Title:Acronym Effectiveness of community-wide promotion of physical activity: a 5-year extended study of a cluster RCT
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 promotion of physical activity for increasing physical activity and reducing musculoskeletal pain in middle-aged and elderly people.This study is an extended study of an intervention study that started in 2009 (UMIN000002683). The original study has already finished 3-years follow-up to its launch. This study extends the intervention period to 5 years and examines its effectiveness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

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 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 Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Control group:
For 5 years, in the control area, public health services were delivered by Unnan City Hall as usual.
Interventions/Control_2 Intervention group:
For 5 years, a community-wide campaign is held to promote aerobic, flexibility, and/or muscle-strengthening activities in the intervention area.
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 elderly people living in the area
Key exclusion criteria Those in assisted living facilities and those who require nursing care
Target sample size 3000

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
2013 Year 12 Month 02 Day

Related information
URL releasing protocol http://www.ijbnpa.org/content/10/1/44/additional
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1093/ije/dyx248
Number of participants that the trial has enrolled
Results Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference=4.6 percentage points (95% confidence interval:0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3 to 3.4%, P>0.138). Linear dose response relationships between the CWI awareness and changes in PA were observed (P<0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. (Kamada M et al., Int J Epidemiol, dyx248, Epub on 2017)
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 Main results already published
Date of protocol fixation
2013 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 24 Day
Last follow-up date
2014 Year 11 Month 30 Day
Date of closure to data entry
2015 Year 01 Month 31 Day
Date trial data considered complete
2015 Year 02 Month 28 Day
Date analysis concluded
2015 Year 05 Month 05 Day

Other
Other related information

Management information
Registered date
2013 Year 12 Month 02 Day
Last modified on
2018 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014564

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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