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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002683
Receipt No. R000003271
Scientific Title Effectiveness of community-wide promotion of aerobic, flexibility, and muscle-strengthening activities on musculoskeletal pain and physical activity in middle- and old- aged people: a cluster RCT
Date of disclosure of the study information 2009/10/28
Last modified on 2013/06/26

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Basic information
Public title Effectiveness of community-wide promotion of aerobic, flexibility, and muscle-strengthening activities on musculoskeletal pain and physical activity in middle- and old- aged people: a cluster RCT
Acronym Effectiveness of community-wide promotion of aerobic, flexibility, and muscle-strengthening activities: a cluster RCT
Scientific Title Effectiveness of community-wide promotion of aerobic, flexibility, and muscle-strengthening activities on musculoskeletal pain and physical activity in middle- and old- aged people: a cluster RCT
Scientific Title:Acronym Effectiveness of community-wide promotion of aerobic, flexibility, and muscle-strengthening activities: a cluster RCT
Region
Japan

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

Objectives
Narrative objectives1 To determine the effectiveness of community-wide promotion of aerobic, flexibility, and muscle-strengthening activities for increasing physical activity and reducing musculoskeletal pain in middle- and old- aged people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in the engagement in regular aerobic, flexibility, and/or muscle-strengthening activities from baseline to 1-year follow-up
Key secondary outcomes Changes in VAS (Visual Analogue Scale) pain scores and chronic pains of shoulder, low back, and knee from baseline to 1-year follow-up

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
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 1 year, residents in the control area live as usual.
Interventions/Control_2 Intervention group:
For 1 year, a community-wide campaign is held to promote aerobic, flexibility, and/or muscle-strengthening activities in the 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- and old- aged 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 Masamitsu Kamada
Organization Physical Education and Medicine Research Center UNNAN
Division name Research Division
Zip code
Address 1212-3 Mitoya, Mitoya Town, Unnan City, Shimane Prefecture, 690-2404, Japan
TEL 0854-45-0300
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masamitsu Kamada
Organization Physical Education and Medicine Research Center UNNAN
Division name Research Division
Zip code
Address 1212-3 Mitoya, Mitoya Town, Unnan City, Shimane Prefecture, 690-2404, Japan
TEL
Homepage URL
Email

Sponsor
Institute Physical Education and Medicine Research Center UNNAN
Institute
Department

Funding Source
Organization Japanese Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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
2009 Year 10 Month 28 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 http://www.ijbnpa.org/content/10/1/44
Number of participants that the trial has enrolled
Results
The 1-year Community-wide campaign did not significantly promote the recommended level of physical activity (adjusted odds ratio: 0.97; 95% confidence interval: 0.84-1.14).(Kamada M et al., Int J Behav Nutr Phys Act. 2013, 10:44)
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 Completed
Date of protocol fixation
2009 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 11 Month 30 Day
Date of closure to data entry
2013 Year 01 Month 31 Day
Date trial data considered complete
2013 Year 02 Month 28 Day
Date analysis concluded
2013 Year 05 Month 05 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 28 Day
Last modified on
2013 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003271

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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