Physical ActivityE-bikeNCT02495740
E-Bike Versus Classic Bike Intervention Trial
A study testing Commuting to work in people with Physical Activity and Obesity, run by University of Basel at 1 site in Switzerland.
Trial summary
The effects of active commuting with an e-bike, as compared with a "classic" bike, on cardiorespiratory fitness and vascular health are largely unknown. To assess whether active commuting with an e-bike or a classic bike increases peak oxygen consumption (VO2peak) in untrained and overweight individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Obesity
- What is being tested?
- Commuting to work
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2012to Apr 2013
- Phase
- Interventional
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index 25-35 kg/m2, and willingness to commute to work by e-bike or by normal bike at least 3 times per week with a one-way distance of ≥ 6 km.
Who cannot join
- cycling as a leisure-time activity, active commuting to work or exercise training more than once per week within 4 weeks before the start of the study, uncontrolled cardiovascular diseases limiting cardiorespiratory fitness, stage II arterial hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 95 mmHg), renal diseases, uncontrolled diabetes mellitus (HbA1c > 6.5%), or active malignancy or chemotherapy during the past 6 months.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department for Sport, Exercise and Health, Sports and Exercise Medicine, University of Basel
Basel, 4052
About this study
Official title: E-Bike Study - Endurance Capacity Following 1 Month Training of Classic Bike Versus Electric-assisted Bike
The effects of active commuting with an e-bike, as compared with a "classic" bike, on cardiorespiratory fitness and vascular health are largely unknown. To assess whether active commuting with an e-bike or a classic bike increases peak oxygen consumption (VO2peak) in untrained and overweight individuals.
Read the detailed description
Riding an electrically assisted bicycle (e-bike) is thought to be suitable to increase physical activity in daily life, to promote health, and to increase cardiorespiratory fitness in normal-weight individuals. The positive effect of commuting to work by a normal bike on cardiorespiratory fitness has been shown to be an important predictor of cardiovascular mortality in previous studies. We thought to improve maximal oxygen uptake by commuting to work by e-bike vs. classic bike. Besides cardiorespiratory fitness we assessed arterial stiffness as brachial-ankle pulse wave velocity as an independent predictor of cardiovascular events and all-cause mortality.
- Conditions
- Physical Activity, Obesity
- Being tested
- Commuting to work
- Medical subject headings
- Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commuting to workBehavioural
Commuting by an electric assisted bike to work for a period of 4 weeks at least 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| E-bike intervention | Experimental | Intervention is active commuting to work by an electric assisted bike to work for a period of 4 weeks at least 3 times per week with a minimal distance of 6 km per way Receives: Behavioral: Commuting to work |
| Bike intervention | Active comparator | Intervention is active commuting to work by classic bike for a period of 4 weeks at least 3 times per week with a minimal distance of 6 km per way Receives: Behavioral: Commuting to work |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal oxygen uptake
maximal oxygen uptake measured on a cycle ergometer with a ramp protocol
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arno Schmidt-Trucksäss, University of Basel
- Investigators
- Arno Schmidt-Trucksäss, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495740
- Sponsor's protocol ID
- EKNZ 2012/164
- Acronym
- E-bike
- Status last verified
- Jul 2015
- First submitted
- 9 Jul 2015
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-Bike Study - Endurance Capacity Following 1 Month Training of Classic Bike Versus Electric-assisted Bike
- ClinicalTrials.gov ID
- NCT02495740
- Acronym / sponsor ID
- E-bike / EKNZ 2012/164
- Conditions
- Physical Activity, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 Jul 2015 (estimated)
- 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.
The effects of active commuting with an e-bike, as compared with a "classic" bike, on cardiorespiratory fitness and vascular health are largely unknown. To assess whether active commuting with an e-bike or a classic bike increases peak oxygen consumption (VO2peak) in untrained and overweight individuals.
Detailed description
Riding an electrically assisted bicycle (e-bike) is thought to be suitable to increase physical activity in daily life, to promote health, and to increase cardiorespiratory fitness in normal-weight individuals. The positive effect of commuting to work by a normal bike on cardiorespiratory fitness has been shown to be an important predictor of cardiovascular mortality in previous studies. We thought to improve maximal oxygen uptake by commuting to work by e-bike vs. classic bike. Besides cardiorespiratory fitness we assessed arterial stiffness as brachial-ankle pulse wave velocity as an independent predictor of cardiovascular events and all-cause mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-bike intervention | Experimental | Behavioral: Commuting to workIntervention is active commuting to work by an electric assisted bike to work for a period of 4 weeks at least 3 times per week with a minimal distance of 6 km per way |
| Bike intervention | Active comparator | Behavioral: Commuting to workIntervention is active commuting to work by classic bike for a period of 4 weeks at least 3 times per week with a minimal distance of 6 km per way |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- body mass index 25-35 kg/m2, and willingness to commute to work by e-bike or by normal bike at least 3 times per week with a one-way distance of ≥ 6 km.
Key exclusion criteria (1 listed)
- cycling as a leisure-time activity, active commuting to work or exercise training more than once per week within 4 weeks before the start of the study, uncontrolled cardiovascular diseases limiting cardiorespiratory fitness, stage II arterial hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 95 mmHg), renal diseases, uncontrolled diabetes mellitus (HbA1c > 6.5%), or active malignancy or chemotherapy during the past 6 months.
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 |
|---|---|---|
| Commuting to workCommuting by an electric assisted bike to work for a period of 4 weeks at least 3 times per week | Behavioural | Bike intervention, E-bike intervention |
Primary outcome
maximal oxygen uptake
Time frame: 4 weeks
maximal oxygen uptake measured on a cycle ergometer with a ramp protocol
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 14 Jul 2015.
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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.
Arno Schmidt-Trucksäss principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commuting to work in people with Physical Activity and Obesity, run by University of Basel at 1 site in Switzerland.
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 1 inclusion and 1 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 14 Jul 2015. 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 Switzerland. 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?
maximal oxygen uptake (time frame: 4 weeks). 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 14 Jul 2015.