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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034325
Receipt No. R000039134
Scientific Title Effect of a group exercise program for older residents in disaster restoration public housing on mental health and health-related quality of life
Date of disclosure of the study information 2018/09/29
Last modified on 2019/08/09

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Basic information
Public title Effect of a group exercise program for older residents in disaster restoration public housing on mental health and health-related quality of life
Acronym Effect of a group exercise program for older residents in disaster restoration public housing on mental health and health-related quality of life
Scientific Title Effect of a group exercise program for older residents in disaster restoration public housing on mental health and health-related quality of life
Scientific Title:Acronym Effect of a group exercise program for older residents in disaster restoration public housing on mental health and health-related quality of life
Region
Japan

Condition
Condition Older residents living in disaster restoration public housing (aged 65 or older)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effect of an exercise intervention program for older residents living in public restoration housing on mental health and health-related quality of life
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes mental health
Key secondary outcomes health-related quality of life, individual social capital, self-efficacy, bodily pain, physical performance, flexibility

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 Subjects allocated in the intervention group will participate in an exercise class held once per week (total 8 times). In this class, supjects will receive a series of lectures about health(significance of exercise, effect of regular exercise on health) and do some low intensity exercise.
Interventions/Control_2 Subjects allocated in the control group will receive a text about information about health (same as the intervention group) via airmail once per week (total 8 times).
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria being with ability to perform daily activities and walk unassisted
Key exclusion criteria inability to understand examiners' instruction and contraindication of any exercise
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Seiji
Middle name
Last name Yasumura
Organization Fukushima Medical University
Division name Department of Public Health
Zip code 960-1295
Address 1, Hikarigaoka, Fukushima City, Fukushima, Japan
TEL 024-547-1180
Email yasumura@fmu.ac.jp

Public contact
Name of contact person
1st name Nobuaki
Middle name
Last name Moriyama
Organization Fukushima Medical University
Division name Department of Public Health
Zip code 960-1295
Address 1, Hikarigaoka, Fukushima City, Fukushima, Japan
TEL 024-547-1184
Homepage URL
Email moriyama@fmu.ac.jp

Sponsor
Institute Department of Public Health, Fukushima Medical University School of Medicine
Institute
Department

Funding Source
Organization Public Health Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukushima Medical University
Address 1, Hikarigaoka, Fukushima City, Fukushima, Japan
Tel 024-547-1825
Email rs@fmu.ac.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
2018 Year 09 Month 29 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 47
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 Completed
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
2018 Year 10 Month 04 Day
Anticipated trial start date
2018 Year 12 Month 07 Day
Last follow-up date
2019 Year 03 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 29 Day
Last modified on
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039134

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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