Plain English Summary
Background and study aims
Cardiac rehabilitation is proven to be effective in coronary artery disease patients and is recommended by the European Society of Cardiology. However the long-term benefits are often poor, because patients do not adopt healthy lifestyle behaviours (including regular exercise training). To overcome this problem, alternative rehabilitation methods have been assessed. Especially for the elderly, electrically-assisted cycling could be a valuable alternative to classical cycling. There is little evidence about this approach and the aim of this observational study is to find out more.
Who can participate?
Adult patients diagnosed with coronary artery disease.
What does the study involve?
Participants perform the same route three times in Hasselt, Belgium. The first time they use a classical bicycle, the second and/or third time an electrically-assisted bicycle. During each cycling period, a number of measurements are taken.
What are the possible benefits and risks of participating?
A risk is that participants could experience exercise-related complications during the cycling period. However, participants are supervised by at least one person who can intervene whenever necessary.
Where is the study run from?
Jessa Hospital, Hasselt (Belgium)
When is the study starting and how long is it expected to run for?
November 2014 to April 2015
Who is funding the study?
Heart Center Hasselt (Belgium)
Who is the main contact?
Professor Dominic Hansen
Trial website
Contact information
Type
Scientific
Primary contact
Prof. dr. Dominique Hansen
ORCID ID
http://orcid.org/0000-0003-3074-2737
Contact details
Stadsomvaart 11
3500 Hasselt
Hasselt
3500
Belgium
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparing the metabolic load of electrically-assisted cycling with classical cycling in coronary artery disease patients after phase II of cardiac rehabilitation.
Acronym
Study hypothesis
The metabolic load of electrically-assisted cycling is significantly different, compared to classical cycling in coronary artery disease patients after phase II of cardiac rehabilitation.
Ethics approval
Jessa Hospital Ethics Committee, 07/112014, ref 14.73/reva14.10.
Study design
Single-centre prospective observational trial
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
ot available in web format, please use the contact details below to request a patient information sheet
Condition
Patients with coronary artery disease, treated with percutaneous coronary intervention or coronary artery bypass grafting.
Intervention
Every patient was requested to perform a cycling route (of 10 km) in Hasselt (Belgium). Patients performed the cycling route 3 times.
The first time, a classical bicycle was used. The second and/or third time electrically assisted bicycles were used (light and heavy assistance).
Intervention type
Other
Phase
Drug names
Primary outcome measures
VO2, assessed by ergospirometry (Oxycon mobile device) during whole cycling sessions.
VO2 was recorded during all cycling sessions.
Secondary outcome measures
1. VCO2, assessed by ergospirometry (Oxycon mobile device) during whole cycling sessions
2. RER, assessed by ergospirometry (Oxycon mobile device) during whole cycling sessions
3. VE, assessed by ergospirometry (Oxycon mobile device) during whole cycling sessions
4. Time of cycling sessions, recorded by stopwatch
5. Perceived exertion, assessed twice at predefined parcours locations with Borg scale
Kcal, deduced from VO2 and total time of cycling sessions
VCO2, RER, VE, perceived exertion (Borg scale) were recorded during all cycling sessions.
VO2 or oxygen consumption - VO2 is defined as the volume of O2 extracted from inspired air in a given period of time.
VCO2 or carbon dioxide output - VCO2 is defined as the amount of CO2 exhaled from the body per unit of time.
RER or respiratory exchange ratio - RER is defined as : RER= VCO2/VO2. The RER is determined by the fuels used for metabolism. RER is 1 for carbohydrates; RER is 0,7 for lipids and RER is 0,85 for carbohydrates and lipids.
VE or minute ventilation - VE is the volume of expired air exhaled from the lungs in 1 minute.
Overall trial start date
01/11/2014
Overall trial end date
01/05/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Coronary artery disease patients, treated with percutaneous coronary intervention or coronary artery bypass grafting
2. Patients should have completed phase II of cardiac rehabilitation
3. Absence of severe pulmonary and/or renal disease
4. Absence of neurological and/or orthopedic disease (that would limit the patient's possibility to cycle)
5. Absence of pacemaker
6. Gender: both male and female
7. Age: between 50-75 years old
8. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15
Participant exclusion criteria
1. Presence of severe pulmonary and/or renal disease
2. Presence of neurological and/or orthopedic disease (that would limit the patient's possibility to cycle)
3. Presence of pacemaker
4. Age: <50 or > 75 years old
Recruitment start date
10/11/2014
Recruitment end date
01/04/2015
Locations
Countries of recruitment
Belgium
Trial participating centre
Jessa Hospital
Stadsomvaart 11
3500 Hasselt
Hasselt
3500
Belgium
Funders
Funder type
Hospital/treatment centre
Funder name
Heart Center Hasselt (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication: submission of article by September 2015.
Dissemination: presentation of trial results at the Belgian Society of Cardiology (BSC) conference 2016.
Intention to publish date
01/12/2015
Participant level data
Available on request
Results - basic reporting
Publication summary