UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057675 |
|---|---|
| Receipt number | R000065904 |
| Scientific Title | Health Promotion through Workplace Indoor Cycling Intervention for Taxi Drivers with Elevated Body Fat |
| Date of disclosure of the study information | 2025/07/30 |
| Last modified on | 2025/04/21 23:56:11 |
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Basic information
Public title
Health Promotion through Workplace Indoor Cycling Intervention for Taxi Drivers with Elevated Body Fat
Acronym
HEALTH CYCLING Study
Scientific Title
Health Promotion through Workplace Indoor Cycling Intervention for Taxi Drivers with Elevated Body Fat
Scientific Title:Acronym
HEALTH CYCLING Study
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Cardiology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to test the hypothesis that implementing indoor cycling at the workplace, in addition to dietary guidance, can reduce body fat percentage while maintaining lean body mass among male taxi drivers with a BMI of 25 kg/m2 or higher or a body fat percentage of 25% or higher.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the change in body fat percentage measured by InBody H30 between the start of the intervention and 90 days after the intervention begins.
Key secondary outcomes
Difference in lean body mass measured by InBody H30 between baseline and 90 days after the start of the intervention
Difference in skeletal muscle mass measured by InBody H30 between baseline and 90 days after the start of the intervention
Difference in BMI measured by InBody H30 between baseline and 90 days after the start of the intervention
Difference in basal metabolic rate measured by InBody H30 between baseline and 90 days after the start of the intervention
Difference in systolic blood pressure between baseline and 90 days after the start of the intervention
Difference in LDL-C between baseline and 90 days after the start of the intervention
Difference in HDL-C between baseline and 90 days after the start of the intervention
Difference in Work Productivity and Activity Impairment (WPAI) scores between baseline and 90 days after the start of the intervention
Difference in SF-12 scores between baseline and 90 days after the start of the intervention
Difference in scores on the Japanese version of the Subjective Happiness Scale (SHS) between baseline and 90 days after the start of the intervention
Difference in scores on the Interdependent Happiness Scale (IHS) between baseline and 90 days after the start of the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
In addition to distributing a pamphlet created by a registered dietitian from the health screening division who is responsible for specific health guidance during workplace health checkups, participants will perform aerobic exercise using fitness bikes installed at each workplace for 30 minutes on workdays, at least three times per week.
Interventions/Control_2
A pamphlet prepared by a registered dietitian in charge of specific health guidance during workplace health checkups will be distributed
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
Male taxi drivers aged between 20 and 70 years
Individuals without a pacemaker or implantable cardioverter-defibrillator, and who can be safely measured using the InBody H30
Individuals with a BMI of 25 kg/m2 or higher, or a body fat percentage of 25% or higher as measured by the InBody H30
Key exclusion criteria
Individuals who are unable to use a smartphone Individuals with orthopedic or neurological conditions that prevent safe use of a bicycle Individuals experiencing chest pain, shortness of breath, palpitations, or joint pain in the lower limbs at rest Individuals who develop chest pain, shortness of breath, palpitations, or joint pain in the lower limbs during daily activities Individuals with implanted metal plates or similar devices Individuals currently undergoing cardiac rehabilitation Individuals with untreated grade three hypertension (systolic blood pressure >=180 mmHg and/or diastolic blood pressure >=110 mmHg), or symptomatic hypertension (with headache) Individuals with symptomatic heart disease (coronary artery disease, valvular disease, arrhythmias, heart failure) who have been advised by a physician to avoid exercise Individuals with other medical conditions that may be aggravated by physical activity Individuals who have been instructed by their primary care physician to restrict physical activity
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Kato |
Organization
Kyoto University Hospital Department of Cardiology
Division name
Center for Precision Medicine and Lifestyle-Related Disease Research
Zip code
606-8507
Address
Kyoto University Graduate School of Medicine Doctor of Medicine Course 54 Shogoin Kawahara-cho,Sakyo-ku, Kyoto
TEL
075-751-4255
erikato@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Kato |
Organization
Kyoto University Hospital Department of Cardiology
Division name
Center for Precision Medicine and Lifestyle-Related Disease Research
Zip code
606-8507
Address
Kyoto University Graduate School of Medicine Doctor of Medicine Course 54 Shogoin Kawahara-cho,Sakyo
TEL
075-751-4255
Homepage URL
http://kyoto-u-cardio.jp/shinryo/rinsyo/clinicalresearch
ctsodan@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
CYCLE Hub & Port
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Hospital
Address
54 Shogoin Kawahara-cho,Sakyo-ku, Kyoto
Tel
075-751-4255
erikato@kuhp.kyoto-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
| 2025 | Year | 07 | Month | 30 | 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
| 2025 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 04 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065904
