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

February 1, 2019 updated by: University Hospital, Clermont-Ferrand

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

Status

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

new e-bikes user

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2017

Primary Completion (ANTICIPATED)

May 1, 2019

Study Completion (ANTICIPATED)

May 1, 2019

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (ACTUAL)

October 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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