Diabetes Mellitus, Type 2NCT03143764
Cardiorespiratory Fitness Using Electrically Assisted Bicycles
A study testing Commuting with electrically assisted bicycles in people with Diabetes Mellitus, Type 2, run by University of Bergen at 3 sites in Norway.
Trial summary
This study aimed to examine cycling time and distance when inactive subjects were provided with electrically assisted bicycles, and secondly, to examine changes in cardiorespiratory fitness. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Commuting with electrically assisted bicycles
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 3 sitesNorway
- Study dates
- 1 Sep 2014to 1 Dec 2016
- 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 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -a desire to cycle to work, residence more than 3km from the workplace, and not physically active according to guidelines
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Department of Global Public Health and Primary Care, University of Bergen
Bergen, 5018
Department of Public Health, Sport and Nutrition, University of Agder
Kristiansand
Department of Education and Sports Science, University of Stavanger
Stavanger
About this study
Official title: Bicycle Usage and Cardiorespiratory Fitness Among Inactive Adults Provided With Electrically Assisted Bicycles
This study aimed to examine cycling time and distance when inactive subjects were provided with electrically assisted bicycles, and secondly, to examine changes in cardiorespiratory fitness.
Read the detailed description
Method: Inactive employees in a selection of public and private corporations in three Norwegian cities were invited to participate. Inclusion criteria were: a desire to cycle to work, residence more than 3km from the workplace, and not physically active according to guidelines. There were 25 participants in the study and we provided them all with electrically assisted bicycles fitted with GPS bike computers to record usage. The participants were followed for three to eight months, 226 days on average. Measures of maximal oxygen uptake were performed before and after the intervention. Demographic characteristics and prior transportation habits were reported in a questionnaire at baseline.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Commuting with electrically assisted bicycles
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commuting with electrically assisted bicyclesBehavioural
25 participants were provided with electrically assisted bicycles fitted with GPS bike computers to record usage
What is being measured
The primary outcome is the main question the study is designed to answer.
examine cycling time
when inactive subjects were provided with electrically assisted Bicycles for 12 months
Measured: 12 months
examine cycling distance
when inactive subjects were provided with electrically assisted Bicycles for 12 months
Measured: 12 months
Secondary outcomes (1)
examine changes in cardiorespiratory fitness
Measurements of V02 max pre- post
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Sep 2014
- Primary completion15 Jun 2015
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Inactive employees in a selection of public and private corporations in three Norwegian cities were invited to participate. Inclusion criteria were: a desire to cycle to work, residence more than 3km from the workplace, and not physically active according to guidelines. There were 25 participants in the study and we provided them all with electrically assisted bicycles fitted with GPS bike computers to record usage. The participants were followed for three to eight months, 226 days on average
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- The GC Rieber Funds, Bergen Council, Helse Stavanger HF, Kristiansand Zoo and Amusement park, National Oilwell Varco Norway AS, General Practitioner-scholarship from the Norwegian Medical Association., Department of Global Public Health and Primary Care, University of Bergen, Department of Education and Sports Science, University of Stavanger, Department of Sports and Physical Activity, Bergen University College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143764
- Sponsor's protocol ID
- UBergenElsykkel
- Status last verified
- May 2017
- First submitted
- 21 Apr 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bicycle Usage and Cardiorespiratory Fitness Among Inactive Adults Provided With Electrically Assisted Bicycles
- ClinicalTrials.gov ID
- NCT03143764
- Acronym / sponsor ID
- UBergenElsykkel
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The GC Rieber Funds, Bergen Council, Helse Stavanger HF, Kristiansand Zoo and Amusement park, National Oilwell Varco Norway AS, General Practitioner-scholarship from the Norwegian Medical Association., Department of Global Public Health and Primary Care, University of Bergen, Department of Education and Sports Science, University of Stavanger, Department of Sports and Physical Activity, Bergen University College
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 15 Jun 2015 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 8 May 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.
This study aimed to examine cycling time and distance when inactive subjects were provided with electrically assisted bicycles, and secondly, to examine changes in cardiorespiratory fitness.
Detailed description
Method: Inactive employees in a selection of public and private corporations in three Norwegian cities were invited to participate. Inclusion criteria were: a desire to cycle to work, residence more than 3km from the workplace, and not physically active according to guidelines. There were 25 participants in the study and we provided them all with electrically assisted bicycles fitted with GPS bike computers to record usage. The participants were followed for three to eight months, 226 days on average. Measures of maximal oxygen uptake were performed before and after the intervention. Demographic characteristics and prior transportation habits were reported in a questionnaire at baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Inactive employees in a selection of public and private corporations in three Norwegian cities were invited to participate. Inclusion criteria were: a desire to cycle to work, residence more than 3km from the workplace, and not physically active according to guidelines. There were 25 participants in the study and we provided them all with electrically assisted bicycles fitted with GPS bike computers to record usage. The participants were followed for three to eight months, 226 days on average
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -a desire to cycle to work, residence more than 3km from the workplace, and not physically active according to guidelines
Key exclusion criteria (1 listed)
- -
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 with electrically assisted bicycles25 participants were provided with electrically assisted bicycles fitted with GPS bike computers to record usage | Behavioural | – |
Primary outcome
examine cycling time
Time frame: 12 months
when inactive subjects were provided with electrically assisted Bicycles for 12 months
examine cycling distance
Time frame: 12 months
when inactive subjects were provided with electrically assisted Bicycles for 12 months
1 secondary outcome
examine changes in cardiorespiratory fitness
Time frame: 12 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 8 May 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commuting with electrically assisted bicycles in people with Diabetes Mellitus, Type 2, run by University of Bergen at 3 sites in Norway.
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 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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?
examine cycling time (time frame: 12 months). The study lists 2 primary outcomes in all. 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 8 May 2017.