UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058411 |
|---|---|
| Receipt number | R000066782 |
| Scientific Title | A Pilot Study to Evaluate the Impact of a Cadence Based Pedometer Application with Financial Incentives on Blood Pressure |
| Date of disclosure of the study information | 2025/07/09 |
| Last modified on | 2025/07/10 17:41:58 |
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Basic information
Public title
A Pilot Study to Evaluate the Impact of a Cadence Based Pedometer Application with Financial Incentives on Blood Pressure
Acronym
A Pilot Study to Evaluate the Impact of a Cadence Based Pedometer Application with Financial Incentives on Blood Pressure
Scientific Title
A Pilot Study to Evaluate the Impact of a Cadence Based Pedometer Application with Financial Incentives on Blood Pressure
Scientific Title:Acronym
A Pilot Study to Evaluate the Impact of a Cadence Based Pedometer Application with Financial Incentives on Blood Pressure
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of a smartphone application that provides financial incentives for achieving walking intensity targets on blood pressure in patients with hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in home morning systolic blood pressure after 8 weeks of app usage
Key secondary outcomes
Change in home morning diastolic blood pressure after 8 weeks of app usage
Change in office systolic blood pressure after 8 weeks of app usage
Change in office diastolic blood pressure after 8 weeks of app usage
Correlation between app usage frequency and reduction in home morning systolic blood pressure after 8 weeks
Correlation between app usage frequency and reduction in office systolic blood pressure after 8 weeks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cadence based Pedometer app with financial incentive
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
| 35 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Aged between 35 and 70 years at the time of consent.
Systolic blood pressure between 130 and 159 mmHg as measured in the office.
Systolic blood pressure >125 mmHg on morning home measurements.
For those taking antihypertensive medication, no planned changes in dosage during the study period.
Ability to walk independently without the use of assistive devices.
Ability to communicate and read/write in Japanese.
provided written informed consent
Key exclusion criteria
Already engages in moderate to vigorous intensity physical activity for >30 minutes on >3 days per week.
Advised by a physician to refrain from exercise for any reason.
Systolic blood pressure >160 mmHg at the time of enrollment (office measurement).
Experiencing chest pain or shortness of breath during exertion.
History of syncope during exercise.
Diagnosed with or suspected of having secondary hypertension based on medical history.
Employed by the principal research institution.
Deemed inappropriate for study participation by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Seo |
Organization
Nagoya City University Department of Cardiology
Division name
Department of Cardiology
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
TEL
052-853-8221
hayashik@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Hayashi |
Organization
Department of Cardiology, Nagoya City University
Division name
Department of Cardiology
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
TEL
052-853-8221
Homepage URL
hayashik@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI, Aichi Health Promotion Foundation FY2025 Grant for Medical Research and Health Promotion Activities
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
Nagoya City University School of Medicine Research Ethics Review Committee
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
Tel
0528515511
clinical_research@med.nagoya-cu.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
| 2025 | Year | 07 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 07 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066782
