Coronary Artery Disease
Conditions
Keywords
Cardiac rehabilitation, Cardiovascular disease, Physical activity, Prevention, Consumer wearables, Step metrics
Brief summary
The goal of this clinical trial is to learn about the effect of a physical activity program, focussing on increasing step volume and step intensity (STEP COACH program), compared to usual care in patients with coronary heart problems. The main question it aims to answer is: What is the effect of the STEP COACH program on physical activity levels in patients with coronary artery disease who participated in cardiac rehabilitation? Participants will be randomised in 2 groups: 1. Control group who receives usual care (i.e., a 3-month cardiac rehabilitation program); 2. STEP COACH group who receives usual care and the 9-month STEP COACH program. Objectively measured changes in physical activity time from pre to post STEP COACH program will be compared between groups to see if participants in the STEP COACH group are able to increase their daily physical activity time more compared to participants in the control group.
Detailed description
People with coronary artery disease are strongly recommended to participate in cardiac rehabilitation programs to improve clinical outcomes and prevent premature death. However, emerging evidence shows that participation in contemporary cardiac rehabilitation programs does not or minimally impact habitual physical activity patterns, and that time spent in physical activity often decreases after completing these programs. Hence, there is a strong need for novel, complementary lifestyle programs to improve long-term adherence to physical activity guidelines in patients with coronary artery disease, as this could attenuate disease progression and the risk for adverse health outcomes. The primary aim of this study is to assess the effect of the 9-month STEP COACH intervention on the daily minutes of moderate-to-vigorous intensity physical activity compared to usual care in patients with coronary artery disease.
Interventions
BEHAVIORALSTEP COACH intervention group
The STEP COACH program will encourage patients to progressively increase the volume (i.e. number of daily steps) and intensity (i.e. cadence \>100 steps/min) of habitual physical activity. To promote behaviour change, participants will receive 3 in-person consultations and additional telephone consultations with the nurse and study team, which focus on knowledge, motivation, action planning, self-monitoring, evaluation and long-term maintenance. Participants will use their own smartwatch or smartphone to track and evaluate their habitual physical activity via an online platform.
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospital admission for CAD (ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), unstable angina pectoris (UAP), or stable angina pectoris (AP)) and/or having undergone a percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); * Referral to cardiac rehabilitation; * 18 years of age or older; * Able to understand and perform study related procedures.
Exclusion criteria
* Unable to give informed consent; * Wheelchair-bound / not physically able to stand or walk; * Language barrier; * CABG surgery expected within 8 weeks after inclusion; * New York Heart Association class III or IV heart failure; * Participation in another interventional study targeting physical activity; * Already adhering to physical activity guidelines (i.e. on average \>8,000 steps/day (smartphone) or \>10,000 steps/day (smartwatch or smartband) in the 6 months prior to inclusion).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily moderate-to-vigorous physical activity (min/day) | Baseline (before cardiac rehabilitation) to 9 months (end of STEP COACH program) | Change in moderate-to-vigorous physical activity time, measured using a thigh-worn accelerometer over 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily moderate-to-vigorous physical activity (min/day) | Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 12 months (follow-up) | Changes in moderate-to-vigorous physical activity time, measured using a thigh-worn accelerometer over 7 days |
| Distance covered during Interval Shuttle Walk Test (m) | Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program) | Changes in total distance covered (m) during the interval shuttle walk test, a measure for functional capacity |
| Health-related quality of life | Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up) | Changes in health-related quality of life (physical, emotional and social domain) will be assessed with the MacNew questionnaire. |
| Stress (cortisol) levels | Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program) | Changes in cortisol levels, measured by hair sampling from the occipital region. |
| Daily step count (steps/day) | Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up) | Changes in number of steps/day, measured using a thigh-worn accelerometer over 7 days |
| Peak 30-min cadence (steps/min) | Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up) | Changes in peak 30-min cadence (steps/min), measured using a thigh-worn accelerometer over 7 days |
| Time at moderate-to-vigorous walking cadence (min) | Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up) | Changes in daily time at moderate-to-vigorous walking cadence (i.e., \>100 steps/min), measured using a thigh-worn accelerometer over 7 days |
| 24-hour movement behaviour distribution | Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up) | Changes in 24-hour movement behaviour distributions, i.e. daily time sleeping, sedentary, standing, light-intensity physical activity, moderate-intensity physical activity and vigorous-intensity physical activity, measured using a thigh-worn accelerometer over 7 days |
Countries
Netherlands
Outcome results
None listed