Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Cardiac Rehabilitation, Exercise Maintenance, Facilitator, Managed Home Exercise, Community Based Exercise
Brief summary
The purpose of this study is to develop a new intervention to improve the transition of patients from structured, supervised exercise to self-managed home- or approved community-based exercise programs in an effort to increase maintenance of exercise behaviour post cardiac rehabilitation (CR). The goal of the study is that those receiving the intervention will engage in at least 30 minutes of physical activity at a moderate or vigorous intensity 5 or more days per week, 26, 52 and 78 weeks after CR compared to those in the usual care group. The new intervention will be delivered by trained exercise facilitators (physiotherapists or exercise specialists) and will make use of: small group counseling teleconferences (5 sessions); personal telephone contacts (3 sessions), and community program demonstrations that would facilitate linkages between patients and approved community programs known as Heart Wise Exercise programs available in Ottawa and Toronto. The trial will be conducted at the Minto Prevention and Rehabilitation Centre at the University of Ottawa Heart Institute and the Cardiovascular Rehabilitation and Prevention Centre at the University Health Network (Peter Munk Cardiac Centre \[PMCC\] and Toronto Rehabilitation Institute \[TRI\]) sites. The study has a target enrollment of 604 participants.
Interventions
BEHAVIORALExercise Facilitator Intervention
The 50 week intervention includes 5 small group counseling teleconferences, 3 personal telephone calls and Heart Wise Exercise program demonstrations. During the teleconferences and personal telephone calls, the facilitator discusses the importance of exercise. Participants review their activity diaries, identify barriers to exercise maintenance experienced to date and brainstorm solutions as a group. In addition, the facilitator conducts community program demonstrations at Heart Wise Exercise program locations in Ottawa and Toronto for interested participants.
Sponsors
Ottawa Heart Institute Research Corporation
Heart and Stroke Foundation of Ontario
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is currently participating in an on-site CR program of ≥ 8-week duration (to ensure that outcomes are not confounded by exposure to home-based or telephone-based case managed programs) * Patient has graduated from CR (to ensure that the study is evaluating an intervention to help sustain and improve maintenance of exercise behaviour * Patient has a documented diagnosis of CAD (to ensure homogeneity of the patient population) * Patient is 18 years of age or older * Patient is able and willing to provide informed consent * Able to walk unaided at 2 mph
Exclusion criteria
* Patient has New York Heart Association class III or IV heart failure (because this might interfere with the ability to achieve recommended exercise levels and to ensure homogeneity of the patient population) * Patient is pregnant, lactating or planning to become pregnant during the study period (because this might interfere with the ability to achieve recommended exercise levels) * Patient is unable to read and understand English or French * Planning to leave the province or region in the next 12 months * Member of the participant's household is already participating in the study * The participant is unable, in the opinion of the qualified investigator, to participate in unsupervised exercise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 9-day Accelerometer-measured Physical Activity of Moderate and Vigorous Intensity | Baseline to 52 weeks | Physical activity will be measured directly by having participants wear the Actigraph GT3X accelerometer (Actigraph, Pensacola, Florida) over the right hip for a 9-day recording period, excluding periods when they are sleeping, swimming, or bathing. The activity monitor provides measurements including activity counts, energy expenditure, and step counts, in addition to activity intensity levels. Participants will be considered to be maintaining exercise at guideline recommended levels if they undertake ≥ 30 minutes of moderate and/or vigorous intensity physical activity on ≥ five days. The results report the average minutes of exercise recorded across the full 9 days wearing the accelerometer. |
| 9-day Accelerometer-measured Physical Activity of Moderate and Vigorous Intensity (>/= 10min Sessions) | Baseline to 52 weeks | Physical activity will be measured directly by having participants wear the Actigraph GT3X accelerometer (Actigraph, Pensacola, Florida) over the right hip for a 9-day recording period, excluding periods when they are sleeping, swimming, or bathing. The activity monitor provides measurements including activity counts, energy expenditure, and step counts, in addition to activity intensity levels. Participants will be considered to be maintaining exercise at guideline recommended levels if they undertake ≥ 30 minutes of moderate and/or vigorous intensity physical activity on ≥ five days. Outcome measure 2 reports the average number of minutes recorded over the full 9 days of wearing the accelerometer, but only when the exercise events last for at least 10 minutes. This differs from Primary Outcome 1 because Primary Outcome 1 is an average of all bouts of exercise regardless of sustained time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Limited Graded Exercise Test With Electrocardiographic Monitoring Using a Ramp Protocol on a Treadmill | Baseline and 52 weeks | A random sub-sample of participants will complete a symptom limited graded exercise test with electrocardiographic monitoring using a ramp protocol on a treadmill at baseline and at 52 weeks. Exercise tolerance will also be assessed using the Duke Activity Status Index (DASI), a self-administered questionnaire that measures a patient's functional capacity and is used as an estimate of an individual's peak oxygen uptake |
| Quality of Life Measured by the the EuroQoL 5D Visual Analogue Scale | Baseline to 52 weeks | The EQ-5D is the current gold standard measure of generic quality of life, has been used in numerous studies and has been validated in many languages. The EQ-5D consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale. The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The Visual analogue scale ranges from 0-100 with 0 rated as the worst health, and 100 being the best health. |
| Cardiovascular Risk Factors Measured by Waist Circumference | 52 weeks | Waist circumference is measured using a non-stretchable standard tape measure. |
| Cardiovascular Risk Factors Measured by Systolic Blood Pressure. | 52 weeks | Systolic blood pressure is measured in a seated position after a five-minute rest period using an automated, non-invasive blood pressure monitor (BPTru) that automatically performs six measurements. The results represent the average measurements of the six measurements taken. |
| Cardiovascular Risk Factors Measured by Body Mass Index | 52 weeks | Height and weight is measured for the determination of body mass index (BMI). |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORRobert Reid, MBA, PhD
Ottawa Heart Institute Research Corporation
PRINCIPAL_INVESTIGATORSherry Grace, PhD
Peter Munk Cardiac Centre
STUDY_CHAIRAndrew Pipe, MD
Ottawa Heart Institute Research Corporation
STUDY_CHAIRCaroline Chessex, MD, MSc
Peter Munk Cardiac Centre
STUDY_CHAIRChris Blanchard, PhD
Dalhousie University
STUDY_CHAIRMurray Krahn, MD, MSc
University of Toronto, Toronto Health Economics and Technology Assessment Collaborative
STUDY_CHAIRDoug Manuel, MD
Institute for Clinical Evaluative Sciences
STUDY_CHAIRKori Kingsbury, MSN, MPA
Cardiac Care Network of Ontario
STUDY_CHAIRJennifer Harris, BSc, PT
Ottawa Heart Institute Research Corporation
STUDY_CHAIRKerri-Anne Mullen, MSc
Institute for Clinical Evaluative Sciences
STUDY_CHAIRAmy Mark, PhD
Ottawa Heart Institute Research Corporation
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.88 years STANDARD_DEVIATION 9.92 |
| Body Mass Index | 28.9 kg/m^2 STANDARD_DEVIATION 5.7 |
| Current Smoker | 7 Participants |
| Employed Full Time | 14 Participants |
| History of chronic kidney disease | 4 Participants |
| History of diabetes mellitus | 84 Participants |
| History of dyslipidemia | 99 Participants |
| History of heart failure | 1 Participants |
| History of hypertension | 94 Participants |
| History of peripheral vascular disease | 2 Participants |
| Indication for Cardiac Rehab Angina | 39 Participants |
| Indication for Cardiac Rehab Coronary artery bypass grafting | 12 Participants |
| Indication for Cardiac Rehab Myocardial Infarction | 30 Participants |
| Indication for Cardiac Rehab Percutaneous coronary intervention | 38 Participants |
| Left ventricular ejection fraction | 54.73 Percetange STANDARD_DEVIATION 10.96 |
| Married or cohabiting | 296 Participants |
| Medication Use Angiotension-converting enzyme inhibitor | 241 Participants |
| Medication Use Angiotension receptor blocker | 18 Participants |
| Medication Use Aspirin | 61 Participants |
| Medication Use Beta-blocker | 54 Participants |
| Medication Use Calcium channel blocker | 11 Participants |
| Medication Use Diabetes medication | 11 Participants |
| Medication Use Diuretic | 7 Participants |
| Medication Use Nitrates | 32 Participants |
| Medication Use Other anti-platlet medication | 179 Participants |
| Medication Use Statin | 15 Participants |
| Prior cardiac history | 15 Participants |
| Race/Ethnicity, Customized Non-white ethnocultural background | 11 Participants |
| Race/Ethnicity, Customized White ethnocultural background | 118 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 314 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 67 | 0 / 158 | 0 / 156 |
| other Total, other adverse events | 0 / 68 | 0 / 67 | 0 / 158 | 0 / 156 |
| serious Total, serious adverse events | 0 / 68 | 0 / 67 | 0 / 158 | 0 / 156 |
Outcome results
None listed