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

U

University of Ottawa Heart Institute

Status and phase

Completed
Phase 3

Conditions

Coronary Artery Disease (CAD)

Treatments

Behavioral: CardioFit

Study type

Interventional

Funder types

Other

Identifiers

NCT00265525
HBR 4855

Details and patient eligibility

About

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.

Full 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.

Enrollment

223 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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 design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

223 participants in 2 patient groups

Cardio fit
Experimental group
Treatment:
Behavioral: CardioFit
Usual Care
No Intervention group

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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