UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030791 |
|---|---|
| Receipt number | R000035158 |
| Scientific Title | Effect of the intervention program to promote physical activity and health behavior of older survivors living in affected areas after the Great East Japan Earthquake |
| Date of disclosure of the study information | 2018/01/12 |
| Last modified on | 2018/08/07 17:14:42 |
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Basic information
Public title
Effect of the intervention program to promote physical activity and health behavior of older survivors living in affected areas after the Great East Japan Earthquake
Acronym
Effect of intervention for promotion of physical activity
Scientific Title
Effect of the intervention program to promote physical activity and health behavior of older survivors living in affected areas after the Great East Japan Earthquake
Scientific Title:Acronym
Effect of intervention for promotion of physical activity
Region
| Japan |
Condition
Condition
Older people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of the intervention program to promote the physical activity level of older people who have lived at temporary housing due to evacuation on mental health
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mental health
Key secondary outcomes
Physical activity level
Grip strength
Gait speed
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implementation of a series of exercise classes (once per week for 8 times)
Interventions/Control_2
No intervention (control)
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
Independence of gait by oneself
Not need assistance in daily lives
Key exclusion criteria
Unable to understand examiners' instruction
Contraindication of any exercise
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Yasumura |
Organization
Fukushima Medical University
Division name
Department of Public Health
Zip code
Address
1, Hikarigaoka, Fukushima City, Fukushima, Japan
TEL
024-547-1177
yasumura@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuaki Moriyama |
Organization
Fukushima Medical University
Division name
Department of Public Health
Zip code
Address
1, Hikarigaoka, Fukushima City, Fukushima, Japan
TEL
024-547-1184
Homepage URL
moriyama@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2018 | Year | 01 | Month | 12 | 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
Results
Decline in Subjective well being was observed in 3 months in both the intervention group and the control group; the difference was not significant but borderline significant (p = 0.06). There was no significant difference in the median of variation in 3 months from the baseline between the intervention and control groups in muscle strength (p = 0.79) and mobility (p = 0.77).
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
| 2017 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 18 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 18 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 18 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 12 | Day |
Last modified on
| 2018 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035158
