Condition category
Circulatory System
Date applied
16/06/2015
Date assigned
08/07/2015
Last edited
06/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Heart Center Hasselt

Sponsor details

Stadsomvaart 11
3500 Hasselt
Hasselt
3500
Belgium

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes