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

March 23, 2022 updated by: Ottawa Heart Institute Research Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

223

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Unversity of Ottawa Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via:
Time Frame: Baseline, 6 and 12 months
Baseline, 6 and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

December 12, 2005

First Submitted That Met QC Criteria

December 13, 2005

First Posted (ESTIMATE)

December 14, 2005

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 23, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBR 4855

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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