Can electrically-assisted bicycles be recommended for patients with heart disease?

ISRCTN	ISRCTN32238279
DOI	https://doi.org/10.1186/ISRCTN32238279
Protocol serial number	N/A
Sponsor	Heart Center Hasselt
Funder	Heart Center Hasselt (Belgium)

Submission date: 16/06/2015
Registration date: 08/07/2015
Last edited: 22/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Dominique Hansen
Scientific

Stadsomvaart 11
3500 Hasselt
Hasselt
3500
Belgium

ORCID ID	0000-0003-3074-2737

Study information

Primary study design	Observational
Study design	Single-centre prospective observational trial
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Comparing the metabolic load of electrically-assisted cycling with classical cycling in coronary artery disease patients after phase II of cardiac rehabilitation.
Study objectives	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(s)	Jessa Hospital Ethics Committee, 07/112014, ref 14.73/reva14.10.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	VO2, assessed by ergospirometry (Oxycon mobile device) during whole cycling sessions. VO2 was recorded during all cycling sessions.
Key secondary outcome measure(s)	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.
Completion date	01/05/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	15
Key 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
Key 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
Date of first enrolment	10/11/2014
Date of final enrolment	01/04/2015

Locations

Countries of recruitment

Belgium

Study participating centre

Jessa Hospital

Stadsomvaart 11
3500 Hasselt
Hasselt
3500
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2018	22/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/01/2019: Publication reference added