UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058885 |
|---|---|
| Receipt number | R000067347 |
| Scientific Title | Impact of Electric Bicycle Commuting among Middle-Aged Women: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/08/26 |
| Last modified on | 2025/08/25 12:21:06 |
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Basic information
Public title
Impact of Electric Bicycle Commuting among Middle-Aged Women: A Randomized Controlled Trial
Acronym
Impact of Electric Bicycle Commuting among Middle-Aged Women: A Randomized Controlled Trial
Scientific Title
Impact of Electric Bicycle Commuting among Middle-Aged Women: A Randomized Controlled Trial
Scientific Title:Acronym
Impact of Electric Bicycle Commuting among Middle-Aged Women: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Health Promotion
Classification by specialty
| Cardiology | Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the physical, mental, and social changes in women aged 40 to under 65, who are regularly employed and do not normally commute by bicycle, when their commuting method was changed to an electric bicycle.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in work productivity from baseline to 90 days post-intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
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
Participants in the intervention group commuted to their workplace using an electric bicycle for approximately 15 to 20 minutes per day.
Interventions/Control_2
Continue their usual commuting method
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
Participants were required to meet all of the following criteria:
1. Women aged 40 to under 65 years.
2. Able to commute by bicycle for part of the route to their workplace.
3. Enrolled in bicycle insurance.
Key exclusion criteria
Participants were excluded if they met any of the following criteria:
1 Unable to use a smartphone.
2 Orthopedic or neurological disorders that prevent cycling or with no prior cycling experience.
3 Experiencing chest pain, dyspnea, palpitations, or joint pain in the lower limbs at rest.
4 Experiencing chest pain, dyspnea, palpitations, or joint pain in the lower limbs during daily activities.
5 Presence of metallic implants in the body.
6 Currently undergoing cardiac rehabilitation.
7 Untreated grade III hypertension or higher (systolic blood pressure 180 mmHg and/or diastolic blood pressure 110 mmHg) or hypertension accompanied by symptoms such as headache.
8 Symptomatic heart disease (e.g., coronary artery disease, valvular disease, arrhythmia, heart failure) for which a physician has restricted exercise.
9 Any other medical condition that may worsen with exercise.
10 Advised by a physician to restrict exercise.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | eri |
| Middle name | |
| Last name | kato |
Organization
Center for Preventive Medicine and Lifestyle-related Diseases, Kyoto University Hospital, Kyoto, Japan
Division name
Department of Cardiology
Zip code
606-8507
Address
54, Shogoin Kawaramachi, Sakyo-ku, Kyoto, 606-8307, Japan
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
Center for Preventive Medicine and Lifestyle-related Diseases, Kyoto University Hospital, Kyoto, Jap
Division name
Department of Cardiology
Zip code
606-8507
Address
54, Shogoin Kawaramachi, Sakyo-ku, Kyoto, 606-8307, Japan
TEL
075-751-4255
Homepage URL
erikato@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Operational Grant
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54, Shogoin Kawaramachi, Sakyo-ku, Kyoto, 606-8307, Japan
Tel
075-366-7618
ethcom 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 | 08 | Month | 26 | 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 | 08 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2026 | 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 | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067347
