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

Coronary Artery Disease (CAD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265525
• Other study ID #: HBR 4855
• Status: Completed
• Phase: Phase 3
• Start date: November 2004
• Est. completion date: August 2007

Study information

• Verified date: March 2022
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: August 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Heart Diseases

Intervention

Behavioral:
• CardioFit
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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	Unversity of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via:		Baseline, 6 and 12 months
Secondary	Measured at baseline, 6 months, and 12 months via follow-up questionnaire:		Baseline, 6 and 12 months
Secondary	Recurrent cardiac events		Baseline, 6 and 12 months
Secondary	Barriers		Baseline, 6 and 12 months
Secondary	Task Self-efficacy		Baseline, 6 and 12 months
Secondary	Outcome expectations		Baseline, 6 and 12 months
Secondary	Social Support		Baseline, 6 and 12 months
Secondary	Perceived environment		Baseline, 6 and 12 months
Secondary	Heart disease specific quality of life		Baseline, 6 and 12 months
Secondary	Use of secondary prevention medications		6 and 12 months
Secondary	Pedometer (9days)		6 and 12 months

External Links

•   University of Ottawa Heart Institute website