Coronary Artery Disease (CAD)
Conditions
Keywords
Randomized Control Trial, Exercise Intervention, Prevention, Rehabilitation
Brief summary
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.
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.
Interventions
BEHAVIORALCardioFit
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.
Sponsors
Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Ontario
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Masking description
The Research Assistants conducting the follow-up assessments were blinded to the participant's treatment allocation.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical Activity: Measured at Baseline (Day of Hospital Discharge), 6 Months and 12 Months Via Pedometer | Baseline, 6 and 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Moderate or Vigorous Physical Activity | baseline to 12 months | — |
| Heart Disease Health-related Quality of Life | 6 months and 12 months | 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORRobert Reid, PhD
University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
STUDY_CHAIRAndrew Pipe, C.M, MD
University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
STUDY_CHAIRLouise Morrin, MBA, B.Sc.
University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
Baseline characteristics
| Characteristic | — |
|---|---|
| Acute Myocardial Infarction this admission | 31 Participants |
| Age, Continuous | 56.4 Years STANDARD_DEVIATION 9 |
| Body Mass Index | 29.3 kg/m2 STANDARD_DEVIATION 4.8 |
| Current smokers | 19 Participants |
| Diabetic | 42 Participants |
| Experiencing first cardiac event | 65 Participants |
| Formal Education | 14.3 Years of Formal Education STANDARD_DEVIATION 3.2 |
| Percutaneous Coronary Intervention this admission | 105 Participants |
| Pre-hospital physical activity level | 14.4 Metabolic Equivalent of Tasks (METs) STANDARD_DEVIATION 18.1 |
| Previous Acute Myocardial Infarction | 24 Participants |
| Previous Coronary Artery Bypass Grafting | 10 Participants |
| Previous Percutaneous Intervention | 29 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 115 | 2 / 108 |
| other Total, other adverse events | 0 / 115 | 0 / 108 |
| serious Total, serious adverse events | 4 / 115 | 7 / 108 |
Outcome results
None listed