Clinical trial NCT03307473: Physical Activity and Sedentary Behaviour Associated With Utilitarian E-bike Use
Official title: Total Physical Activity and Sedentary Behaviour Changes Associated With Regular Daily Life Utilitarian E-bike Use : VELONAPS Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: All-comers
Keywords: Physical activity
Bicycling
Transportation
Public health
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: ONAPS : Observatoire National de l'Activité Physique et de la Sédentarité
First posted: 2017-10-11
Enrollment: 54
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: new e-bikes user

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total physical activity
timeFrame: at 4 months
Secondary outcomes:
measure: Sedentary time
timeFrame: at 4 months
measure: Physical condition
timeFrame: at 4 months
measure: Exercise motivations questionnaire
timeFrame: at 4 months
measure: Quality of life questionnaire
timeFrame: at 4 months
measure: Weight
timeFrame: at 4 months
measure: Waist size
timeFrame: at 4 months
measure: Perceived exertion
timeFrame: at 4 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martine DUCLOS
role: PRINCIPAL_INVESTIGATOR
References: