All-comers Clinical Trial
Official title:
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.
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.
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