UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050306 |
|---|---|
| Receipt number | R000057280 |
| Scientific Title | The Effectiveness of Multicomponent Program in Community-Dwelling Older Adults with Social Frailty |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2025/02/08 21:43:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Effectiveness of Multicomponent Program in Community-Dwelling Older Adults with Social Frailty
Acronym
The Effectiveness of Multicomponent Program in Community-Dwelling Older Adults with Social Frailty
Scientific Title
The Effectiveness of Multicomponent Program in Community-Dwelling Older Adults with Social Frailty
Scientific Title:Acronym
The Effectiveness of Multicomponent Program in Community-Dwelling Older Adults with Social Frailty
Region
| Japan |
Condition
Condition
Community-dwelling older adults with social frailty
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of multicomponent program that consists of health education, physical activity, and interpersonal interaction in community-dwelling older adults with social frailty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity
Key secondary outcomes
Social frailty
Frequency of going out
Physical performance
Health related Quality of life
Low back pain
Disturbance of activities of daily living due to low back pain
Loneliness
Frequency of interpersonal interaction
Self-rated health
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
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: once-weekly multicomponent program Intervention for 8 weeks
Interventions/Control_2
Control group: distribute brochures on physical activity
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
1. Being social frailty or social pre-frailty
2. Being agreed with participation in the study
Key exclusion criteria
1. To have difficulty walking independently
2. Those with general cognitive decline (Mini-cog score less than 3 points)
3. Having serious disease which requires exercise limitation (i.e., cardiovascular, respiratory)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino City, Osaka 583-8555, Japan
TEL
072-950-2111
Higu_reha@omu.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Gen |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino City, Osaka 583-8555, Japan
TEL
072-950-2111
Homepage URL
sf22311p@st.omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Applying to the Osaka Gas Group Welfare Foundation (Grant decision will be notified in March 2023.)
Result: Rejected
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Welfare Promotion Division, Osaka Area Management Department, West Japan Branch, UR Urban Organization
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University
Address
3-7-30 Habikino, Habikino City, Osaka 583-8555, Japan
Tel
072-950-2111
sf22311p@st.omu.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 | 02 | Month | 10 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/39829964/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39829964/
Number of participants that the trial has enrolled
64
Results
PA was not affected by the intervention. A significant group-by-time interaction was observed for loneliness, with a medium
effect size (p < 0.05), indicating that loneliness was significantly reduced in the intervention group compared to the control group.
Results date posted
| 2025 | Year | 02 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no significant differences in the participants' baseline demographic and clinical characteristics between the two groups.
Participant flow
A total of 103 men and women aged over 60 years were enrolled in this study, of whom 83 had social frailty or pre-frailty. However, we excluded two participants with suspected cognitive impairment and 17 who did not participate in the baseline assessment. The remaining 64 participants, all of whom met the inclusion criteria, were randomly assigned to the IG (n = 34) and the CG (n = 30). In the IG, two participants withdrew from the study, resulting in a class participation rate of 93.8%. Additionally, five participants in the IG and one in the CG did not meet the criteria for PA monitor compliance. Furthermore, one participant in the CG was absent from the post-intervention assessment.
Adverse events
No adverse events were observed during the study.
Outcome measures
Primary outcome: Physical activity (daily steps, light physical activity, moderate-to-vigorous physical activity, sedentary behavior)
Secondary outcome: Loneliness (Three-Item Loneliness Scale), EQ-5D-5L, Low back pain (visual analog scale), Short Physical Performance Battery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 09 | 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 | 02 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057280
