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

NCT ID: NCT00265525

Last Updated: 2022-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-08-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease (CAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cardio fit

Group Type EXPERIMENTAL

CardioFit

Intervention Type BEHAVIORAL

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.

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role collaborator

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

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University of Ottawa Heart Institute

Principal Investigators

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Robert Reid, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa Heart Institute, Prevention and Rehabilitation Centre

Andrew Pipe, C.M, MD

Role: STUDY_CHAIR

University of Ottawa Heart Institute, Prevention and Rehabilitation Centre

Louise Morrin, MBA, B.Sc.

Role: STUDY_CHAIR

University of Ottawa Heart Institute, Prevention and Rehabilitation Centre

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Unversity of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 21903744 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21450579 (View on PubMed)

Related Links

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http://www.ottawaheart.ca/

University of Ottawa Heart Institute website

Other Identifiers

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HBR 4855

Identifier Type: -

Identifier Source: org_study_id

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