- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03307473
Physical Activity and Sedentary Behaviour Associated With Utilitarian E-bike Use (VELONAPS)
Total Physical Activity and Sedentary Behaviour Changes Associated With Regular Daily Life Utilitarian E-bike Use : VELONAPS Study
Physical inactivity and sedentary are recognized as important risks factors for several diseases and total mortality. One of the main perceived barriers to physical activity is the lack of time and motivation. Active commuting during daily routine could overcome these barriers and e-bikes appears to be a promising and practical tool to meet physical activity guidelines.
E-bikes are a physically active transportation mode, with a riding intensity contributing to activities in the moderate-intensity range (3-6 METs) for any of the assistance mode. Electric assistance is provided only when a rider is pedaling. The study VELONAPS mainly aims at investigating if real-life usage of utilitarian e-bike is associated with significant changes on total physical activity and sedentary patterns. During up to 4 months of free use of an e-bike, our purpose is to quantify its usage along with total physical activity and sedentary levels. We hypothesize that using an e-bike for commuting increase the total physical activity of at least 7.5 MET-h/week, increasing as well adherence to physical activity guidelines.
Study Overview
Detailed Description
During 3 months in a the geographic area of Clermont-Ferrand (France), new e-bike buyers and renters are invited to take part in VELONAPS study before starting to use their e-bike. The sample is constituted of willing participants who plan to use their e-bike, at least in part, for work-related and commuter trips. Each participant will be followed during 4 months, with 4 study points.
At T0, subjects are invited for the baseline visit including a medical interview and physical examination (with anthropometric measurements), and a physical stress test evaluating aerobic fitness (submaximal step-test). Online questionnaires are provided to measure physical activity and sedentary patterns (RPAQ), motivations and barriers to physical activity (EMAPS and BPAQ), perceived health and quality of life (SF-12), perceived exertion for common physical efforts (Borg scale).
At T1 and T2 (respectively one and two months after having started e-bike use), the questionnaire measuring physical activity and sedentary patterns of the past month is requested again.
At T4 (final study point, after 4 months of e-bike use), subjects are invited for the follow-up visit including anthropometric measurements and a physical stress test evaluating aerobic fitness. Online questionnaires are provided to measure the same dimensions than at the T0 study point.
The primary endpoint of the study is to compare the physical activity level at T0 and the one at T4.
Secondary endpoints are the modifications (comparisons between T0 and T4) in :
- sedentary levels.
- the percent of individuals meeting the physical activity guidelines.
- motivations and barriers to physical activity.
- perceived health and quality of life.
- perceived exertion for common physical efforts.
- anthropometric measurements (BMI and waist size). Subgroup analyses will identify either consistency of, of large differences, in the magnitude of e-bike use effect among different categories of participants: by age, by sex, by initial physical condition, and by initial total physical activity level.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Recruiting
- Chu Clermont-Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- being a new e-bikes user
- planning to use the e-bikes, at least in part, for work-related and commuter trips
Exclusion Criteria:
- having used regularly (more than once a week) an e-bike for at least one month during the last three months
- e-bike use already started for more than a week
- e-bike use only for leisure activities (no commuting)
- health condition(s) contraindicating a fitness test
- being pregnant
- not having access to the e-bike for a long period (> 1 month) during the follow-up study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
e-bike
During 3 months in a the geographic area of Clermont-Ferrand (France), new e-bike buyers and renters are invited to take part in VELONAPS study before starting to use their e-bike
|
During 3 months in a the geographic area of Clermont-Ferrand (France), new e-bike buyers and renters are invited to take part in VELONAPS study before starting to use their e-bike
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total physical activity
Time Frame: at 4 months
|
the amount of total physical activity engaged in each week (in MET-h/week).
|
at 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sedentary time
Time Frame: at 4 months
|
Total of time while sitting, lying down, and expending very little energy (approximately 1.0-1.5 metabolic equivalents [METs]) in each day (in h/day).
|
at 4 months
|
Physical condition
Time Frame: at 4 months
|
Estimated aerobic fitness (in METs)
|
at 4 months
|
Exercise motivations questionnaire
Time Frame: at 4 months
|
factor structure examination of the Behavioural Regulation in exercise questionnaire-2 (BREQ-2)
|
at 4 months
|
Quality of life questionnaire
Time Frame: at 4 months
|
Assessment of health related quality of life using SF-12 questionnaire
|
at 4 months
|
Weight
Time Frame: at 4 months
|
Body weight
|
at 4 months
|
Waist size
Time Frame: at 4 months
|
Waist size measurement (between the last/lowest rib, and the hip bone)
|
at 4 months
|
Perceived exertion
Time Frame: at 4 months
|
Rating of perceived exertion for common physical stresses.
|
at 4 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHU-354
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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