Tokyo, Aug. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058885) titled 'Impact of Electric Bicycle Commuting among Middle-Aged Women: A Randomized Controlled Trial' on Aug. 26.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - No treatment
Primary Sponsor:
Institute - Kyoto University
Condition:
Condition - Health Promotion
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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
Eligibility:
Age-lower limit - 40
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 Size - 40
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067347
Disclaimer: Curated by HT Syndication.
