Back to resultsCardiorespiratory Fitness Using Electrically Assisted Bicycles
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Commuting with electrically assisted bicycles
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
-a desire to cycle to work, residence more than 3km from the workplace, and not physically active according to guidelines
Exclusion Criteria:
-
Sites / Locations
- Department of Global Public Health and Primary Care, University of Bergen
- Department of Public Health, Sport and Nutrition, University of Agder
- Department of Education and Sports Science, University of Stavanger
Outcomes
Primary Outcome Measures
examine cycling time
when inactive subjects were provided with electrically assisted Bicycles for 12 months
examine cycling distance
when inactive subjects were provided with electrically assisted Bicycles for 12 months
Secondary Outcome Measures
examine changes in cardiorespiratory fitness
Measurements of V02 max pre- post
Full Information
NCT ID
NCT03143764
First Posted
April 21, 2017
Last Updated
May 3, 2017
Sponsor
University of Bergen
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
1. Study Identification
Unique Protocol Identification Number
NCT03143764
Brief Title
Cardiorespiratory Fitness Using Electrically Assisted Bicycles
Official Title
Bicycle Usage and Cardiorespiratory Fitness Among Inactive Adults Provided With Electrically Assisted Bicycles
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2014 (Actual)
Primary Completion Date
June 15, 2015 (Actual)
Study Completion Date
December 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bergen
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Commuting with electrically assisted bicycles
Intervention Description
25 participants were provided with electrically assisted bicycles fitted with GPS bike computers to record usage
Primary Outcome Measure Information:
Title
examine cycling time
Description
when inactive subjects were provided with electrically assisted Bicycles for 12 months
Time Frame
12 months
Title
examine cycling distance
Description
when inactive subjects were provided with electrically assisted Bicycles for 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
examine changes in cardiorespiratory fitness
Description
Measurements of V02 max pre- post
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-a desire to cycle to work, residence more than 3km from the workplace, and not physically active according to guidelines
Exclusion Criteria:
-
Facility Information:
Facility Name
Department of Global Public Health and Primary Care, University of Bergen
City
Bergen
ZIP/Postal Code
5018
Country
Norway
Facility Name
Department of Public Health, Sport and Nutrition, University of Agder
City
Kristiansand
Country
Norway
Facility Name
Department of Education and Sports Science, University of Stavanger
City
Stavanger
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiorespiratory Fitness Using Electrically Assisted Bicycles
We'll reach out to this number within 24 hrs