UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034325 |
|---|---|
| Receipt number | 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 15:54:26 |
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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
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
moriyama@fmu.ac.jp
Sponsor or person
Institute
Department of Public Health, Fukushima Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039134
