UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061091 |
|---|---|
| Receipt number | R000069905 |
| Scientific Title | Feasibility Study of a Remote Physical Activity Monitoring Program Using Fitbit: A 12-Week Trial Targeting Middle-Aged and Older Adults with Chronic Pain |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/28 08:24:59 |
* 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
A Feasibility Study on a Physical Activity Monitoring Program for Middle-Aged and Older Adults with Chronic Pain
Acronym
A Feasibility Study on a Physical Activity Monitoring Program for Middle-Aged and Older Adults with Chronic Pain
Scientific Title
Feasibility Study of a Remote Physical Activity Monitoring Program Using Fitbit: A 12-Week Trial Targeting Middle-Aged and Older Adults with Chronic Pain
Scientific Title:Acronym
Feasibility Study of a Remote Physical Activity Monitoring Program for Middle-Aged and Older Adults with Chronic Pain
Region
| Japan |
Condition
Condition
Middle-aged and older adults with chronic pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the feasibility of a program in which participants use a remote monitoring system we developed using Fitbit to track their activity levels, while physical therapists provide remote feedback once a week.
Basic objectives2
Others
Basic objectives -Others
This study verifies the program's feasibility.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Program satisfaction, sense of accomplishment, and psychological burden at 12 weeks post-intervention (all rated on a 5-point scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self-reporting of daily physical activity levels by participants
Weekly remote feedback and information sessions provided by a physical therapist
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People attending outpatient physical therapy at the study site
People aged 50 or older
People experiencing pain that has lasted for three months or longer
People who use smartphones on a daily basis and are accustomed to operating them
Key exclusion criteria
People whose activities are restricted by a doctor due to heart disease or other medical conditions
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Higuchi |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health Cae
Zip code
370-0033
Address
27 Nakaorui-machi, Takasaki-shi, Gunma
TEL
027-352-1291
higuchi-d@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Higuchi |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health Care
Zip code
370-0033
Address
27 Nakaorui-machi, Takasaki-shi, Gunma
TEL
027-352-1291
Homepage URL
higuchi-d@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Zenshukai Hospital
Address
54-1 Utsuboi-machi, Maebashi-shi, Gunma Prefecture
Tel
027-261-5410
higuchi-d@takasaki-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
| 2026 | Year | 04 | 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 | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 03 | Month | 28 | Day |
Last modified on
| 2026 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069905
