Back to resultsEvaluation of a Web-based Intervention to Promote Physical Activity in Patients With Heart Disease.
Primary Purpose
Coronary Artery Disease (CAD)
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
CardioFit
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease (CAD) focused on measuring Randomized Control Trial, Exercise Intervention, Prevention, Rehabilitation
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
Sites / Locations
- London Health Sciences Centre
- Unversity of Ottawa Heart Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cardio fit
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via:
Secondary Outcome Measures
Measured at baseline, 6 months, and 12 months via follow-up questionnaire:
Recurrent cardiac events
Barriers
Task Self-efficacy
Outcome expectations
Social Support
Perceived environment
Heart disease specific quality of life
Use of secondary prevention medications
Pedometer (9days)
Full Information
NCT ID
NCT00265525
First Posted
December 12, 2005
Last Updated
March 23, 2022
Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Heart and Stroke Foundation of Ontario
1. Study Identification
Unique Protocol Identification Number
NCT00265525
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ottawa Heart Institute Research Corporation
Collaborators
Heart and Stroke Foundation of Ontario
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD)
Keywords
Randomized Control Trial, Exercise Intervention, Prevention, Rehabilitation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardio fit
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
CardioFit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via:
Time Frame
Baseline, 6 and 12 months
Secondary Outcome Measure Information:
Title
Measured at baseline, 6 months, and 12 months via follow-up questionnaire:
Time Frame
Baseline, 6 and 12 months
Title
Recurrent cardiac events
Time Frame
Baseline, 6 and 12 months
Title
Barriers
Time Frame
Baseline, 6 and 12 months
Title
Task Self-efficacy
Time Frame
Baseline, 6 and 12 months
Title
Outcome expectations
Time Frame
Baseline, 6 and 12 months
Title
Social Support
Time Frame
Baseline, 6 and 12 months
Title
Perceived environment
Time Frame
Baseline, 6 and 12 months
Title
Heart disease specific quality of life
Time Frame
Baseline, 6 and 12 months
Title
Use of secondary prevention medications
Time Frame
6 and 12 months
Title
Pedometer (9days)
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Reid, PhD
Organizational Affiliation
University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Pipe, C.M, MD
Organizational Affiliation
University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Louise Morrin, MBA, B.Sc.
Organizational Affiliation
University of Ottawa Heart Institute, Prevention and Rehabilitation Centre
Official's Role
Study Chair
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Unversity of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21903744
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.
Results Reference
derived
PubMed Identifier
21450579
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.
Results Reference
derived
Links:
URL
http://www.ottawaheart.ca/
Description
University of Ottawa Heart Institute website
Learn more about this trial
Evaluation of a Web-based Intervention to Promote Physical Activity in Patients With Heart Disease.
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