All-comersVELONAPSNCT03307473
Physical Activity and Sedentary Behaviour Associated With Utilitarian E-bike Use
An observational study of All-comers, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- All-comers
- What is being tested?
- E6BIKE
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: new e-bikes user
Who may be able to join
- being a new e-bikes user
- planning to use the e-bikes, at least in part, for work-related and commuter trips
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- All-comers
- Being tested
- E6BIKE
- Keywords
- Physical activity, Bicycling, Transportation, Public health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E6BIKEBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: E6BIKE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total physical activity
the amount of total physical activity engaged in each week (in MET-h/week).
Measured: at 4 months
Secondary outcomes (7)
Sedentary time
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).
Measured: at 4 months
Physical condition
Estimated aerobic fitness (in METs)
Measured: at 4 months
Exercise motivations questionnaire
factor structure examination of the Behavioural Regulation in exercise questionnaire-2 (BREQ-2)
Measured: at 4 months
Quality of life questionnaire
Assessment of health related quality of life using SF-12 questionnaire
Measured: at 4 months
Weight
Body weight
Measured: at 4 months
Waist size
Waist size measurement (between the last/lowest rib, and the hip bone)
Measured: at 4 months
Perceived exertion
Rating of perceived exertion for common physical stresses.
Measured: at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start15 Sep 2017
- Primary completion20 Nov 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All-comersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- ONAPS : Observatoire National de l'Activité Physique et de la Sédentarité
- Responsible party
- Sponsor
- Investigators
- Martine DUCLOS, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307473
- Sponsor's protocol ID
- CHU-354
- Acronym
- VELONAPS
- Status last verified
- Mar 2019
- First submitted
- 2 Oct 2017
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Physical Activity and Sedentary Behaviour Changes Associated With Regular Daily Life Utilitarian E-bike Use : VELONAPS Study
- ClinicalTrials.gov ID
- NCT03307473
- Acronym / sponsor ID
- VELONAPS / CHU-354
- Conditions
- All-comers
- Keywords
- Physical activity, Bicycling, Transportation, Public health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- ONAPS : Observatoire National de l'Activité Physique et de la Sédentarité
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| e-bike | – | Behavioral: E6BIKEDuring 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 |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- new e-bikes user
Key inclusion criteria (2 listed)
- being a new e-bikes user
- planning to use the e-bikes, at least in part, for work-related and commuter trips
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E6BIKEDuring 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 | Behavioural | e-bike |
Primary outcome
Total physical activity
Time frame: at 4 months
the amount of total physical activity engaged in each week (in MET-h/week).
7 secondary outcomes
Sedentary time
Time frame: at 4 months
Physical condition
Time frame: at 4 months
Exercise motivations questionnaire
Time frame: at 4 months
Quality of life questionnaire
Time frame: at 4 months
Weight
Time frame: at 4 months
Waist size
Time frame: at 4 months
Perceived exertion
Time frame: at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine DUCLOS principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All-comers, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total physical activity (time frame: at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.