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

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT00265525
First received: December 12, 2005
Last updated: May 6, 2010
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease (CAD)
 Behavioral: CardioFit
Behavioral: Usual care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluation of a Web-Based Intervention to Promote Physical Activity in Patients With Heart Disease: A Randomize Control Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via: [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measured at baseline, 6 months, and 12 months via follow-up questionnaire: [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Recurrent cardiac events [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Barriers [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Task Self-efficacy [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Outcome expectations [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Social Support [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Perceived environment [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Heart disease specific quality of life [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
  • Use of secondary prevention medications [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Pedometer (9days) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 223
Study Start Date: November 2004
Study Completion Date: August 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardio fit 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.
No Intervention: Usual Care Behavioral: Usual care
Usual care will consist of an educational booklet and physical activity advice the cardiologist would typically provide.

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265525

Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Unversity of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Sponsors and Collaborators
University of Ottawa Heart Institute
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Robert Reid, PhD University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
Study Chair: Andrew Pipe, C.M, MD University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
Study Chair: Louise Morrin, MBA, B.Sc. University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
  More Information

Additional Information:
University of Ottawa Heart Institute website  This link exits the ClinicalTrials.gov site

No publications provided by University of Ottawa Heart Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert Reid/Principal Investigator, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT00265525     History of Changes
Other Study ID Numbers: HBR 4855
Study First Received: December 12, 2005
Last Updated: May 6, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Ottawa Heart Institute:
Randomized Control Trial
Exercise Intervention
Prevention
Rehabilitation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013