UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002683 |
|---|---|
| Receipt number | 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 15:25:29 |
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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
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
Sponsor or person
Institute
Physical Education and Medicine Research Center UNNAN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003271
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
