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 2023/01/17 18:50:02

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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.)


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

Email

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


Email

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

Email

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


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

3939

Results


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

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

2023 Year 01 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028377


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name