UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050618 |
|---|---|
| Receipt number | R000057008 |
| Scientific Title | Group-based application intervention to promote physical activity among community-dwelling older adults: a non-randomized controlled trial |
| Date of disclosure of the study information | 2023/03/17 |
| Last modified on | 2024/02/21 16:25:21 |
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Basic information
Public title
Group-based application intervention to promote physical activity among community-dwelling older adults: a non-randomized controlled trial
Acronym
Group-based application intervention to promote physical activity among community-dwelling older adults: a non-randomized controlled trial
Scientific Title
Group-based application intervention to promote physical activity among community-dwelling older adults: a non-randomized controlled trial
Scientific Title:Acronym
Group-based application intervention to promote physical activity among community-dwelling older adults: a non-randomized controlled trial
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Group-based application interventions for older adults to increase physical activity
Basic objectives2
Others
Basic objectives -Others
Long-term effectiveness testing of group-based application interventions
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes after intervention in objectively measured steps
Key secondary outcomes
Changes after intervention in objectively measured physical activity (light intensity physical activity, moderate to vigorous intensity physical activity), Changes after intervention in subjectively measured steps Physical function (grip strength, CS-30), Self-efficacy
Changes in physical activity, physical function and self-efficacy one year after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Fitness promotion for encouragement of physical activity, wearing a triaxial accelerometer (before and after intervention for approximately 1 week) and use of a smartphone group-based application in 12 weeks
Interventions/Control_2
Fitness promotion for encouragement of physical activity, wearing a triaxial accelerometer (before and after intervention for approximately 1 week)
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. Men and women over 65 years old
2. Not restricted from walking by a physician
3. Walking independently
4. Able to type text on a smartphone (Intervention group only)
Key exclusion criteria
1. Persons who unable to participate safely in a physical activity program based on responses to PAR-Q.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | YUKO |
| Middle name | |
| Last name | OGUMA |
Organization
Keio University
Division name
Sports Medicine Research Center
Zip code
223-0061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
TEL
045-566-1090
yoguma@keio.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Tabira |
Organization
Keio University
Division name
Sports Medicine Research Center
Zip code
223-0061
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagwa
TEL
045-566-1090
Homepage URL
kjump617@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Yuko Oguma
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fujisawa City Hall, A10 Lab Co.,Ltd.
Name of secondary funder(s)
Kanagawa Institute of Industrial Science and Technology
IRB Contact (For public release)
Organization
IRB, Sports Medicine Research Center, Keio University
Address
4-1-1 Hiyoshi, Kohoku-ku, Yokohama, Kanagawa
Tel
045-566-1090
smrc-info@ml.keio.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 | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
74
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
| 2022 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After the 12-week intervention, study participants may receive a one-year follow-up if they wish. To test the long-term effects of the group-based application intervention.
Management information
Registered date
| 2023 | Year | 03 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057008
| 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 |
