UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041990 |
|---|---|
| Receipt number | R000047925 |
| Scientific Title | Intervention to promote exercise behavior among older adults under the epidemic of COVID-19 |
| Date of disclosure of the study information | 2020/10/02 |
| Last modified on | 2022/04/04 10:18:10 |
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Basic information
Public title
Intervention to promote exercise behavior among older adults under the epidemic of COVID-19
Acronym
Intervention to promote exercise behavior among older adults under the epidemic of COVID-19
Scientific Title
Intervention to promote exercise behavior among older adults under the epidemic of COVID-19
Scientific Title:Acronym
Intervention to promote exercise behavior among older adults under the epidemic of COVID-19
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of self-regulation intervention on promotion of exercise behavior among older adult under the epidemic of COVID-19
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise Behavior
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: To provide leaflet containing self-regulation techniques by postal mail (once a week, totally 7 weeks)
Interventions/Control_2
Control group: Waiting list
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Without any restrictions for exercise participation
Key exclusion criteria
With any restrictions for exercise participation
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Harada |
Organization
Kobe University
Division name
Graduate School of Human Development and Environment
Zip code
657-8501
Address
3-11 Tsurukabuto, Nada, Kobe
TEL
078-803-7886
harada@harbor.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Harada |
Organization
Kobe University
Division name
Graduate School of Human Development and Environment
Zip code
657-8501
Address
3-11 Tsurukabuto, Nada, Kobe
TEL
078-803-7886
Homepage URL
harada@harbor.kobe-u.ac.jp
Sponsor or person
Institute
Graduate School of Human Development and Environment, Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe City Office
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Human Development and Environment, Kobe University
Address
3-11 Tsurukabuto, Nada, Kobe
Tel
078-803-7905
hudev-soumu@office.kobe-u.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
| 2020 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
doi: 10.1007/s12529-021-10049-3
Publication of results
Published
Result
URL related to results and publications
doi: 10.1007/s12529-021-10049-3
Number of participants that the trial has enrolled
393
Results
Exercise behavior was promoted after the intervention in both intervention and waiting list groups.
Results date posted
| 2022 | Year | 04 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
165 men and 228 women. The mean age, 74.0 years (SD = 6.5 years)
Participant flow
424 individuals agreed to participate in the trial. Among them, 393 individuals who met the eligibility criteria and responded to the baseline survey were randomly assigned to either intervention group or waiting list group. 372 individuals completed the final survey.
Adverse events
None
Outcome measures
Exercise Behavior
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 02 | Day |
Last modified on
| 2022 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047925
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
