Physical Activity and Sedentary Behaviour Associated With Utilitarian E-bike Use

All-comers Clinical Trial

— VELONAPS  

Official title:

Total Physical Activity and Sedentary Behaviour Changes Associated With Regular Daily Life Utilitarian E-bike Use : VELONAPS Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03307473
• Other study ID #: CHU-354
• Status: Recruiting
• Start date: September 15, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• All-comers

Intervention

Behavioral:
• E6BIKE
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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	ONAPS : Observatoire National de l’Activité Physique et de la Sédentarité

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total physical activity	the amount of total physical activity engaged in each week (in MET-h/week).	at 4 months
Secondary	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).	at 4 months
Secondary	Physical condition	Estimated aerobic fitness (in METs)	at 4 months
Secondary	Exercise motivations questionnaire	factor structure examination of the Behavioural Regulation in exercise questionnaire-2 (BREQ-2)	at 4 months
Secondary	Quality of life questionnaire	Assessment of health related quality of life using SF-12 questionnaire	at 4 months
Secondary	Weight	Body weight	at 4 months
Secondary	Waist size	Waist size measurement (between the last/lowest rib, and the hip bone)	at 4 months
Secondary	Perceived exertion	Rating of perceived exertion for common physical stresses.	at 4 months