UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012464 |
|---|---|
| Receipt number | 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 09:28:38 |
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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
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
shintai@bs.kkm.ne.jp
Sponsor or person
Institute
Physical Education and Medicine Research Center UNNAN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014564
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| Registered date | File name |
| Research case data | |
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