UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055258 |
|---|---|
| Receipt number | R000063138 |
| Scientific Title | the Effectiveness of a Physical Activity Program Using Nudging to Improve Depressive Symptoms in Older Adult |
| Date of disclosure of the study information | 2024/08/20 |
| Last modified on | 2025/08/16 09:52:13 |
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Basic information
Public title
Activity Program to Boost Well-being in Older Adults
Acronym
Well-being Project
Scientific Title
the Effectiveness of a Physical Activity Program Using Nudging to Improve Depressive Symptoms in Older Adult
Scientific Title:Acronym
Nudging Older Adults Depression Improvement Study
Region
| Japan |
Condition
Condition
depressive symptoms
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effectiveness of a physical activity program using nudging theory in improving depressive symptoms.
Basic objectives2
Others
Basic objectives -Others
The program includes seven weekly lectures and two measurement sessions before and after the lectures. After the first measurement, participants will be randomly assigned to Group A (intervention) or Group B (control) for a 2-week intervention (AB, Period 1). After a 2-week washout period, Group A and B will switch roles for another 2-week intervention (BA, Period 2). During the washout, lectures will cover general knowledge, not activity promotion.
The intervention involves sending nudging flyers and phone calls from the principal investigator. Nudging interventions 1-6 are included in the flyers, and intervention 7 involves direct phone calls to encourage activity.
Measurement sessions will assess basic information, depressive symptoms, functional abilities, nutrition, incontinence, and physical and mental health (e.g., height, weight, cognitive screening, body composition, strength, and activity level). During the washout, only activity and depressive symptoms will be evaluated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Geriatric Depression Scale 15 items
Key secondary outcomes
physical activity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group A (intervention group) will receive a two-week intervention (nudging message flyers and phone calls), while Group B will serve as the control group. After a two-week washout period, Group A will become the control group, and Group B (intervention group) will receive a two-week intervention (nudging message flyers and phone calls).
Interventions/Control_2
Group A (intervention group) will receive a two-week intervention (nudging message flyers and phone calls), while Group B will serve as the control group. After a two-week washout period, Group A will become the control group, and Group B (intervention group) will receive a two-week intervention (nudging message flyers and phone calls).
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
65 years and older
Key exclusion criteria
Individuals with difficulty walking, Individuals with severe cognitive impairment, Individuals with a pacemaker implanted, Individuals diagnosed with an aneurysm or deep vein thrombosis (DVT)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Ando |
Organization
Aino university
Division name
Faculty of Health Sciences, Department of Physical Therapy
Zip code
5670012
Address
4-5-4 Higashi-Oda, Ibaraki City, Osaka Prefecture
TEL
0726271711
s-ando@pt-u.aino.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Ando |
Organization
Aino university
Division name
Faculty of Health Sciences, Department of Physical Therapy
Zip code
5670012
Address
4-5-4 Higashi-Oda, Ibaraki City, Osaka Prefecture
TEL
0726271711
Homepage URL
s-ando@pt-u.aino.ac.jp
Sponsor or person
Institute
Aino university
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Aino university
Address
4-5-4 Higashi-Oda, Ibaraki City, Osaka Prefecture
Tel
0726271711
s-ando@pt-u.aino.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
| 2024 | Year | 08 | Month | 20 | 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
23
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
| 2024 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063138
