Coronary Artery Disease (CAD)NCT00265525

Evaluation of a Web-based Intervention to Promote Physical Activity in Patients With Heart Disease.

A study testing CardioFit in people with Coronary Artery Disease (CAD), run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Coronary Artery Disease (CAD)
What is being tested?: CardioFit
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 223 participants
Where: 2 sitesCanada
Study dates: Nov 2004to Aug 2007
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 20 to 80 years
English Proficiency
Internet Access (home or work)
Documented CAD (most recent cardiac diagnosis); documented Myocardial Infarction (MI), successful PCI procedure

Who cannot join

Patient intends to enroll in structured cardiac rehabilitation
Hospitalization for Coronary Artery Bypass (CABG)
Hospitalization for diagnostic procedure not associated with previously documented MI
Patient coming back to hospital for planned staged PCI within 6 months
Cardiac transplantation
Presence of, or hospitalization for defibrillator implant

Show all 21Show fewer

Hospitalization for pacemaker implantation
Unresolved unstable angina \&/or hospitalization for angina (without MI or PCI)
Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise
Other uncontrolled metabolic conditions (e.g. diabetes)
Chronic infectious diseases such as mononucleosis, hepatitis, AIDS
Acute systematic illness or fever
Uncontrolled tachycardia (<120 bpm)
Uncompensated congestive heart failure (\&/or NYHA Class III, or IV)
3rd degree AV block without pacemaker
Active pericarditis or myocarditis
Recent embolism
Suspected or known AAA aneurysm > 4cm
Uncontrolled hypertension (SBP > 200; DBP > 110)
Pregnancy

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

London Health Sciences Centre
London, Ontario, N6A 5W9
Unversity of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7

Other trials in Canada

About this study

Official title: Evaluation of a Web-Based Intervention to Promote Physical Activity in Patients With Heart Disease: A Randomize Control Trial

A randomized control trial (RCT) is planned to evaluate a web-based intervention (CardioFit) against usual care in increasing physical activity levels in patients with Coronary Artery Disease (CAD). We hypothesize that compared to usual care, participants in CardioFit will; a) have increased physical activity levels, b) will have a higher health-related quality of life at measurement dates and, c) will have greater improvements in psychosocial predictors.

Read the detailed description

Most existing cardiac rehabilitation programs have little ability to expand participation using traditional delivery models that emphasize supervised, facility-based programs. Futhermore, facility based programs to promote physical activity behavior in patients with coronary artery disease (CAD) are limited in their impact because most patients are unwilling to travel more than 30-40 minutes to participate in a program. CardioFit is an off-site, 26 week web-based physical activity coaching service for people with heart disease. Within the CardioFit program, patients will be assigned to an on-line "coach" and receive customized exercise programs based on their medical history, personal goals and preferences. A randomized control trial (RCT) is planned to evaluate the effectiveness of the web-based intervention at increasing physical activity levels against usual care in patients with CAD.

This study is in the third phase of a three-phase research program to examine interventions to promote physical activity for the secondary prevention of Cardiovascular disease.

Conditions: Coronary Artery Disease (CAD)
Being tested: CardioFit
Keywords: Randomized Control Trial, Exercise Intervention, Prevention, Rehabilitation
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CardioFitBehavioural
CardioFit is a 26-week tailored web-based physical activity coaching service for individuals with Coronary Artery Disease (CAD). It has been designed to help patients develop personalized exercise programs based on their medical history, personal goals and preferences. Access to Cardio-fit is through a secured website. The cardio-fit website contains physical activity advice and heart health educational information. Each patient is assigned an on-line coach, whose role is to assist in creating safe an effective physical activity program, and to answer any questions that patients may have throughout the program.

Study groups in NCT00265525
Study group	Role	What they receive
Cardio fit	Experimental	Not described Receives: Behavioral: CardioFit
Usual Care	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Physical Activity: Measured at Baseline (Day of Hospital Discharge), 6 Months and 12 Months Via Pedometer
Measured: Baseline, 6 and 12 months

Secondary outcomes (2)

Moderate or Vigorous Physical Activity
Measured: baseline to 12 months
Heart Disease Health-related Quality of Life
Measured at 6months and 12months via MacNew instrument. Each subscale ranges from 1-7 (1 = worse quality of life, 7 = better quality of life), and is reported independently from each of the other subscales.
Measured: 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2004Aug 2007

First posted14 Dec 2005 (estimated)
Study startNov 2004
Primary completionJun 2007
Study completionAug 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00265525
Sponsor's protocol ID: HBR 4855
Status last verified: Mar 2022
First submitted: 12 Dec 2005
Last updated: 30 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Reid RD, Morrin LI, Beaton LJ, Papadakis S, Kocourek J, McDonnell L, Slovinec D'Angelo ME, Tulloch H, Suskin N, Unsworth K, Blanchard C, Pipe AL. Randomized trial of an internet-based computer-tailored expert system for physical activity in patients with heart disease. Eur J Prev Cardiol. 2012 Dec;19(6):1357-64. doi: 10.1177/1741826711422988. Epub 2011 Sep 8.
PubMed 21903744
Reid RD, Morrin LI, Higginson LA, Wielgosz A, Blanchard C, Beaton LJ, Nelson C, McDonnell L, Oldridge N, Wells GA, Pipe AL. Motivational counselling for physical activity in patients with coronary artery disease not participating in cardiac rehabilitation. Eur J Prev Cardiol. 2012 Apr;19(2):161-6. doi: 10.1177/1741826711400519. Epub 2011 Feb 21.
PubMed 21450579

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease (CAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a Web-Based Intervention to Promote Physical Activity in Patients With Heart Disease: A Randomize Control Trial
ClinicalTrials.gov ID: NCT00265525
Acronym / sponsor ID: HBR 4855
Conditions: Coronary Artery Disease (CAD)
Keywords: Randomized Control Trial, Exercise Intervention, Prevention, Rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 223 participants (actual)
Lead sponsor: Ottawa Heart Institute Research CorporationUniversity, hospital or other
Collaborators: Heart and Stroke Foundation of Ontario
Study start: Nov 2004
Primary completion: Jun 2007 (actual)
Study completion: Aug 2007 (actual)
First posted: 14 Dec 2005 (estimated)
Results: Posted 30 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study is in the third phase of a three-phase research program to examine interventions to promote physical activity for the secondary prevention of Cardiovascular disease.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 2

Arm	Type	Receives
Cardio fit	Experimental	Behavioral: CardioFit
Usual Care	No intervention	–

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age 20 to 80 years
English Proficiency
Internet Access (home or work)
Documented CAD (most recent cardiac diagnosis); documented Myocardial Infarction (MI), successful PCI procedure

Key exclusion criteria (21 listed)

Patient intends to enroll in structured cardiac rehabilitation
Hospitalization for Coronary Artery Bypass (CABG)
Hospitalization for diagnostic procedure not associated with previously documented MI
Patient coming back to hospital for planned staged PCI within 6 months
Cardiac transplantation

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
CardioFitCardioFit is a 26-week tailored web-based physical activity coaching service for individuals with Coronary Artery Disease (CAD). It has been designed to help patients develop personalized exercise programs based on their medical history, personal goals and preferences. Access to Cardio-fit is through a secured website. The cardio-fit website contains physical activity advice and heart health educational information. Each patient is assigned an on-line coach, whose role is to assist in creating safe an effective physical activity program, and to answer any questions that patients may have throughout the program.	Behavioural	Cardio fit

Primary outcome

Physical Activity: Measured at Baseline (Day of Hospital Discharge), 6 Months and 12 Months Via Pedometer
Time frame: Baseline, 6 and 12 months

2 secondary outcomes

Moderate or Vigorous Physical Activity
Time frame: baseline to 12 months
Heart Disease Health-related Quality of Life
Time frame: 6 months and 12 months

Results and safety

Results posted to the registry on 30 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cardio Fit	115	79
Usual Care	108	74

Primary outcome: Physical Activity: Measured at Baseline (Day of Hospital Discharge), 6 Months and 12 Months Via Pedometer

Time frame: Baseline, 6 and 12 months. Mean (Standard Deviation). Unit: Number of Steps per day over 7 days

Measure	Cardio Fit n = 115	Usual Care n = 108
6 months	7079 (3159)	6186 (3159)
12 months	7392 (3365)	6750 (3366)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cardio Fit	4 of 115 (3.5%)	0 of 115 (0%)	0 of 115
Usual Care	7 of 108 (6.5%)	0 of 108 (0%)	2 of 108

Limitations and caveats (from the sponsor): * measurement of physical activity may have made patients more aware of their physical activity, increasing it above their normal habits. To mitigate this, data from the first and ninth day were removed from the analysis. * greater attrition rate than in previous similar studies. * the generalizability of the results may have been affected due to the high education of the participants and the low number of female participants. * exercise was not observed, so may have been exaggerated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21903744Reid RD, Morrin LI, Beaton LJ, Papadakis S, Kocourek J, McDonnell L, Slovinec D'Angelo ME, Tulloch H, Suskin N, Unsworth K, Blanchard C, Pipe AL. Randomized trial of an internet-based computer-tailored expert system for physical activity in patients with heart disease. Eur J Prev Cardiol. 2012 Dec;19(6):1357-64. doi: 10.1177/1741826711422988. Epub 2011 Sep 8.
Derived from this study: PubMed 21450579Reid RD, Morrin LI, Higginson LA, Wielgosz A, Blanchard C, Beaton LJ, Nelson C, McDonnell L, Oldridge N, Wells GA, Pipe AL. Motivational counselling for physical activity in patients with coronary artery disease not participating in cardiac rehabilitation. Eur J Prev Cardiol. 2012 Apr;19(2):161-6. doi: 10.1177/1741826711400519. Epub 2011 Feb 21.
University of Ottawa Heart Institute websiteLink provided by the sponsor.

Related trials for Coronary Artery Disease (CAD)

Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
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Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction

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.

Robert Reid, PhD principal investigator

University of Ottawa Heart Institute, Prevention and Rehabilitation Centre

Andrew Pipe, C.M, MD study chair

University of Ottawa Heart Institute, Prevention and Rehabilitation Centre

Louise Morrin, MBA, B.Sc. study chair

University of Ottawa Heart Institute, Prevention and Rehabilitation Centre

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CardioFit in people with Coronary Artery Disease (CAD), run by Ottawa Heart Institute Research Corporation at 2 sites in Canada.

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 4 inclusion and 21 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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?

Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Physical Activity: Measured at Baseline (Day of Hospital Discharge), 6 Months and 12 Months Via Pedometer (time frame: Baseline, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00265525, which also lists 2 linked publications.

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 30 Jun 2026.