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NCT Number: NCT07723274

A Physical Activity Programme Focussed on Step Volume and Intensity for People With Cardiovascular Disease: Getting Active and Staying Active After Cardiac Rehabilitation

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Coronary Disease Heart Diseases Motor Activity Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate, Arnhem, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

STEP COACH intervention group

Behavioral

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.

Primary outcomes

  1. Daily moderate-to-vigorous physical activity (min/day)

    Time frame: 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 outcomes

  1. Daily moderate-to-vigorous physical activity (min/day)

    Time frame: 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

  2. Distance covered during Interval Shuttle Walk Test (m)

    Time frame: 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

  3. Health-related quality of life

    Time frame: 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.

  4. Stress (cortisol) levels

    Time frame: 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.

  5. Daily step count (steps/day)

    Time frame: 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

  6. Peak 30-min cadence (steps/min)

    Time frame: 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

  7. Time at moderate-to-vigorous walking cadence (min)

    Time frame: 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

  8. 24-hour movement behaviour distribution

    Time frame: 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

Other outcomes

  1. Cost-effectiveness of the STEP COACH intervention

    Time frame: Baseline (before cardiac rehabilitation) to 12 months (follow-up)

    The results of the EQ-5D-5L questionnaire (i.e., the participants' health state) will be converted into quality-adjusted life years (QALYs). The costs considered for the cost-effectiveness analysis of the RCT are direct costs of the STEP COACH program and of the care utilisation.

  2. Long-term clinical outcomes

    Time frame: Baseline (before cardiac rehabilitation) to 15 years of follow-up

    All-cause mortality and major adverse cardiac events (MACE)

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Step Targets for Patients With Coronary Artery Disease: Towards Better Physical Activity Adherence Following Cardiac Rehab - A Randomised Controlled Trial

Acronym: STEP COACH RCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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