UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024682 |
|---|---|
| Receipt number | 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 | 2026/06/18 09:07:08 |
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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 6-year* follow-up
(*Changed from 5 to 6 years; the follow-up survey was postponed for one year due to the July 2021 heavy rainfall disaster.)
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 6-year* follow-up, certification of needed long-term care, and mortality
(*Changed from 5 to 6 years; the follow-up survey was postponed for one year due to the July 2021 heavy rainfall disaster.)
In addition, the above-mentioned outcomes over 10 years (2010-2026) for the long-term evaluation of the intervention. Disease incidence, certification of needed long-term care, and mortality will be assessed until 2027.
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 6 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.
(*Changed from 5 to 6 years; the follow-up survey was postponed for one year due to the July 2021 heavy rainfall disaster.)
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 | Jun |
| Middle name | |
| Last name | kitayuguchi |
Organization
Physical Education and Medicine Research Center UNNAN
Division name
Research Division
Zip code
6991105
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 | Jun |
| Middle name | |
| Last name | kitayuguchi |
Organization
Physical Education and Medicine Research Center UNNAN
Division name
Research Division
Zip code
6991105
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
Institutional Review Board of Physical Education and Medicine Research Center UNNAN
Address
328 Uji, Kamo Town, Unnan City, Shimane Prefecture, 699-1105, Japan
Tel
0854499050
shintai@bs.kkm.ne.jp
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000028377
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39587639/
Number of participants that the trial has enrolled
3939
Results
1)two-year follow up
The two-year intervention was implemented in all communities, reaching and involving various groups. The rate of people engaged in PA significantly increased in two years (adjusted change: + 8.0 percentage points [95% confidence interval: 6.1, 10.0]).
Results date posted
| 2026 | Year | 06 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 11 | Month | 25 | Day |
Baseline Characteristics
In the randomly sampled population, the proportion of males was 50.4% (3,530/7,000), with an average age of 60.4 years, whereas the proportion of males was 47.8% (1,776/3,718) among respondents, with an average age of 62.0 years.
Participant flow
The present scale-up intervention covered the entire Unnan City, which consists of 30 communities (equivalent to elementary school districts) while the former cRCT was implemented in 12 randomly selected communities. Following the methodology of the preceding cRCT, which considered the units of residents'(communities') social activities, this scale-up study regarded Yokaichi and Sanshinto as the same community in the analysis. Thus, the study analyzed a total of 29 communities.
Adverse events
1)two-year follow up
Two adverse events (harms: 1 muscle spasm; 1 fall without injury) occurred during the educational program, but no serious injuries were reported.
Outcome measures
The primary outcome was the change in the percentage of people who practiced the recommended levels of PA
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
| 2016 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 02 | Day |
Last modified on
| 2026 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028377
