UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044835 |
|---|---|
| Receipt number | R000051180 |
| Scientific Title | Effects of an online learning program for health promotion and care prevention |
| Date of disclosure of the study information | 2021/08/10 |
| Last modified on | 2025/03/20 09:27:26 |
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Basic information
Public title
Effects of an online learning program for health promotion and care prevention
Acronym
Effects of an online learning program for care prevention
Scientific Title
Effects of an online learning program for health promotion and care prevention
Scientific Title:Acronym
Effects of an online learning program for care prevention
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of an online learning program for care prevention by video-conferencing on lifestyles and function in older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity
Key secondary outcomes
Physical function
Frailty
Cognitive function
Health literacy
Diet
Psycho-social factors (Depressive symptom, Social network)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: active learning health education by web-conferencing (once a week for 12 weeks)
Interventions/Control_2
Control group: Lecture on health without active leaning/Online delivery of educational materials (once a week for 12 weeks)
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
1. Being independent in basic activities of daily living
2. Being able to use e-mail on a computer
Key exclusion criteria
1. Dementia, cognitive impairment
2. Having severe diseases that can limit physical activity (i.e., cardiac, pulmonary, or musculoskeletal disease)
3. Needing long-term care
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Uemura |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-City, Osaka
TEL
0729502111
kuemura@omu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Uemura |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-City, Osaka
TEL
0729502111
Homepage URL
kuemura@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Research ethics committee of Toyama Prefectural University
Address
5180 Kurokawa, Imizu, Toyama
Tel
0766-56-7500
y-uwai@pu-toyama.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
| 2021 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
https://journals.humankinetics.com/view/journals/japa/32/6/article-p730.xml
Publication of results
Published
Result
URL related to results and publications
https://journals.humankinetics.com/view/journals/japa/32/6/article-p730.xml
Number of participants that the trial has enrolled
29
Results
Adherence to the intervention was 83%-100% (mean, 97%). Compared with the control group, the intervention group showed moderate maintenance effects on total physical activity and sedentary behavior at 36 weeks. Active learning physical activity intervention through video conferencing was found to be feasible and contributed to the prevention of physical activity decline in older adults.
Results date posted
| 2025 | Year | 03 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We included adults aged 65 years or older who had a computer at home with access to the internet and could use e-mail.
Participant flow
Of the 31 participants, 29 were eligible and randomized into two groups (15 for the intervention and 14 for the control).
Adverse events
No adverse events attributable to the intervention, such as falls during online sessions, were observed.
Outcome measures
The amount of physical activity and sedentary behavior was measured using an accelerometer at baseline, postintervention, and 24-week postintervention (36 weeks).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2021 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051180
