NCT00265525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2004

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

2.6 years

First QC Date

December 12, 2005

Last Update Submit

March 23, 2022

Conditions

Keywords

Randomized Control TrialExercise InterventionPreventionRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Physical activity: measured at baseline (day of hospital discharge), 6 months and 12 months via:

    Baseline, 6 and 12 months

Secondary Outcomes (10)

  • Measured at baseline, 6 months, and 12 months via follow-up questionnaire:

    Baseline, 6 and 12 months

  • Recurrent cardiac events

    Baseline, 6 and 12 months

  • Barriers

    Baseline, 6 and 12 months

  • Task Self-efficacy

    Baseline, 6 and 12 months

  • Outcome expectations

    Baseline, 6 and 12 months

  • +5 more secondary outcomes

Study Arms (2)

Cardio fit

EXPERIMENTAL
Behavioral: CardioFit

Usual Care

NO INTERVENTION

Interventions

CardioFitBEHAVIORAL

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.

Cardio fit

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Unversity of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Robert Reid, PhD

    University of Ottawa Heart Institute, Prevention and Rehabilitation Centre

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2005

First Posted

December 14, 2005

Study Start

November 1, 2004

Primary Completion

June 1, 2007

Study Completion

August 1, 2007

Last Updated

March 24, 2022

Record last verified: 2022-03

Locations