UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051432 |
|---|---|
| Receipt number | R000058368 |
| Scientific Title | Testing the Effect of Increasing Physical Activity by Delivering Home Exercise Videos to the Elderly: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/12/22 09:40:35 |
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Basic information
Public title
Does Delivering Home Exercise Videos to the Elderly Increase Physical Activity? : A Randomized Controlled Trial
Acronym
Does Delivering Home Exercise Videos to the Elderly Increase Physical Activity?: RCT
Scientific Title
Testing the Effect of Increasing Physical Activity by Delivering Home Exercise Videos to the Elderly: A Randomized Controlled Trial
Scientific Title:Acronym
Testing the Effect of Increasing Physical Activity by Delivering Home Exercise Videos to the Elderly: RCT
Region
| Japan |
Condition
Condition
Decreased physical activity due to musculoskeletal disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of distributing home exercise videos to homebound seniors to increase their physical activity levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Physical Activity (IPAQ-SF).
This is a survey on the amount of physical activity per week.
Key secondary outcomes
Subjective well-being (WHO-5)
Social Capital
Anxiety Rating (K6)
Lifestyle (Breslow's 7 Healthy Habits)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Home exercise video distribution group: Group distributed QR codes to view three types of exercise videos
Interventions/Control_2
Control group: A group to which no exercise videos were distributed
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
Those who are 65 years of age or older at the time of consent
Those who have access to the Internet and are able to view the videos (including those who are able to view the videos with the assistance of family members)
Persons who can obtain written consent to participate in this study
Key exclusion criteria
Persons who have or have had a disease that prohibits them from exercising
Those who have been diagnosed as having cognitive problems
Other persons who are deemed inappropriate by the principal investigator or research coordinator
Target sample size
104
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Urabe |
Organization
Graduate school of Hiroshima university
Division name
Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5405
yurabe@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Maeda |
Organization
Graduate school of Hiroshima university
Division name
Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5410
Homepage URL
norimmi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima university
Institute
Department
Personal name
Funding Source
Organization
Yuumi Memorial Foundation for Home Health Care
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-seisaku@office.hiroshima-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
| 2023 | Year | 07 | Month | 01 | 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
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058368
| 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 |
