UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063036 |
|---|---|
| Receipt number | R000072160 |
| Scientific Title | Evaluating the Effectiveness of Exercise Classes Using Online Applications for Older Adults Living in the Community |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/29 09:56:56 |
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Basic information
Public title
Evaluating the Effectiveness of Exercise Classes Using Online Applications for Older Adults Living in the Community
Acronym
Evaluating the Effectiveness of Exercise Classes Using Online Applications for Older Adults Living in the Community
Scientific Title
Evaluating the Effectiveness of Exercise Classes Using Online Applications for Older Adults Living in the Community
Scientific Title:Acronym
Evaluating the Effectiveness of Exercise Classes Using Online Applications for Older Adults Living in the Community
Region
| Japan |
Condition
Condition
Community-Dwelling Older Adults with Physical Pre-Frailty(65years old or more)
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the effectiveness of exercise classes utilizing IoT devices for older adults living in the community
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Weight loss, walking speed, grip strength, exhaustion, exercise habits, Kihon checklist
Key secondary outcomes
Frailty-related items: oral function, gait, posture, general cognitive function, motor function test, body composition, employment status, work motivation, subjective health perspective, nutrition intake, food diversity score, sleep status, biochemical data (AST, ALT, gamma-GT, uric acid, albumin, triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, blood glucose, HbA1c, creatine kinase, urea nitrogen, creatinine, CRP, calcium, inorganic phosphorus,), physical activity, depression, life spread, basic checklist, flexibility, 3D motion analysis, oral function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group: Perform original community-based exercise program for 10 sessions over 3 months. In addition, only the intervention group used a smartphone app developed as a preventive care tool for three months.On days when there is no in-person exercise program, both groups will have an on-demand delivered exercise program.
Interventions/Control_2
Active Control group: Original community-based exercise program for the elderly should be performed in 11 sessions over 3 months. On days when there is no in-person exercise program, both groups will have an on-demand delivered exercise program.
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) older adults who have participated in cohort studies, 2) Native speaker 3) No limitations on age, sex, and medications.
Key exclusion criteria
1)Doctors orders to stop exercise
2) Medically advised not to participate in exercise
3) Dementia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | masakazu |
| Middle name | |
| Last name | imaoka |
Organization
IZUMI University
Division name
Department of Rehabilitation
Zip code
5970104
Address
Mizuma158 Kaizuka city, Osaka
TEL
07244466700
imaokamasakazu@gmail.com
Public contact
Name of contact person
| 1st name | masakazu |
| Middle name | |
| Last name | imaoka |
Organization
IZUMI University
Division name
Department of Rehabilitation
Zip code
5970104
Address
Mizuma158 Kaizuka city, Osaka
TEL
07244466700
Homepage URL
imaokamasakazu@gmail.com
Sponsor or person
Institute
IZUMI University
Institute
Department
Personal name
Masakazu Imaoka
Funding Source
Organization
FUJI OIL CO.,LTD
Fuji Oil Group Holdings, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
FUJI OIL CO.,LTD
Fuji Oil Group Holdings, Ltd.
Nara Women's University
Section of elder care, Kaizuka City
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IZUMI University
Address
Mizuma158
Tel
07244466700
imaokamasakazu@gmail.com
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
| 2026 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072160
