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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:
ClinicalTrials.gov Identifier:
NCT00265525
First Posted: December 14, 2005
Last Update Posted: April 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
Ottawa Heart Institute Research Corporation
  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 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Ottawa Heart Institute Research Corporation:

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 ]

Secondary Outcome Measures:
  • Measured at baseline, 6 months, and 12 months via follow-up questionnaire: [ Time Frame: Baseline, 6 and 12 months ]
  • Recurrent cardiac events [ Time Frame: Baseline, 6 and 12 months ]
  • Barriers [ Time Frame: Baseline, 6 and 12 months ]
  • Task Self-efficacy [ Time Frame: Baseline, 6 and 12 months ]
  • Outcome expectations [ Time Frame: Baseline, 6 and 12 months ]
  • Social Support [ Time Frame: Baseline, 6 and 12 months ]
  • Perceived environment [ Time Frame: Baseline, 6 and 12 months ]
  • Heart disease specific quality of life [ Time Frame: Baseline, 6 and 12 months ]
  • Use of secondary prevention medications [ Time Frame: 6 and 12 months ]
  • Pedometer (9days) [ Time Frame: 6 and 12 months ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Ottawa Heart Institute Research Corporation
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:
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
First Submitted: December 12, 2005
First Posted: December 14, 2005
Last Update Posted: April 8, 2015
Last Verified: March 2009

Keywords provided by Ottawa Heart Institute Research Corporation:
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


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