Clinical trial NCT00265525: Evaluation of a Web-based Intervention to Promote Physical Activity in Patients With Heart Disease.
Official title: Evaluation of a Web-Based Intervention to Promote Physical Activity in Patients With Heart Disease: A Randomize Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease (CAD)
Keywords: Randomized Control Trial
Exercise Intervention
Prevention
Rehabilitation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2005-12-14
Enrollment: 223
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via:
timeFrame: Baseline, 6 and 12 months
Secondary outcomes:
measure: Measured at baseline, 6 months, and 12 months via follow-up questionnaire:
timeFrame: Baseline, 6 and 12 months
measure: Recurrent cardiac events
timeFrame: Baseline, 6 and 12 months
measure: Barriers
timeFrame: Baseline, 6 and 12 months
measure: Task Self-efficacy
timeFrame: Baseline, 6 and 12 months
measure: Outcome expectations
timeFrame: Baseline, 6 and 12 months
measure: Social Support
timeFrame: Baseline, 6 and 12 months
measure: Perceived environment
timeFrame: Baseline, 6 and 12 months
measure: Heart disease specific quality of life
timeFrame: Baseline, 6 and 12 months
measure: Use of secondary prevention medications
timeFrame: 6 and 12 months
measure: Pedometer (9days)
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Unversity of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
name: Robert Reid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
name: Andrew Pipe, C.M, MD
role: STUDY_CHAIR
affiliation: University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
name: Louise Morrin, MBA, B.Sc.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.