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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: STEP COACH intervention 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.

• Study Type: Interventional
• Enrollment (Estimated): 334
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Arnhem, Netherlands, 6815AD
    • Rijnstate
  • Nijmegen, Netherlands, 6525GA
    • Radboud University Medical Center
  • Nijmegen, Netherlands, 6532SZ
    • Canisius Wilhelmina Ziekenhuis
  • Uden, Netherlands, 5406PT
    • Bernhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care group; The usual care group will receive a 3-month cardiac rehabilitation program, as recommended by international guidelines. The cardiac rehabilitation program consists of individual consultations with the nurse specialist on lifestyle, medical and psychosocial wellbeing, and an outpatient exercise program with a physiotherapist.
Experimental: STEP COACH intervention group; The intervention group receives a 9-month, nurse-delivered physical activity intervention in addition to cardiac rehabilitation (i.e., usual care).	Behavioral: STEP 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily moderate-to-vigorous physical activity (min/day)	Change in moderate-to-vigorous physical activity time, measured using a thigh-worn accelerometer over 7 days	Baseline (before cardiac rehabilitation) to 9 months (end of STEP COACH program)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily moderate-to-vigorous physical activity (min/day)	Changes in moderate-to-vigorous physical activity time, measured using a thigh-worn accelerometer over 7 days	Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 12 months (follow-up)
Distance covered during Interval Shuttle Walk Test (m)	Changes in total distance covered (m) during the interval shuttle walk test, a measure for functional capacity	Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
Health-related quality of life	Changes in health-related quality of life (physical, emotional and social domain) will be assessed with the MacNew questionnaire.	Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Stress (cortisol) levels	Changes in cortisol levels, measured by hair sampling from the occipital region.	Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
Daily step count (steps/day)	Changes in number of steps/day, measured using a thigh-worn accelerometer over 7 days	Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Peak 30-min cadence (steps/min)	Changes in peak 30-min cadence (steps/min), measured using a thigh-worn accelerometer over 7 days	Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Time at moderate-to-vigorous walking cadence (min)	Changes in daily time at moderate-to-vigorous walking cadence (i.e., >100 steps/min), measured using a thigh-worn accelerometer over 7 days	Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
24-hour movement behaviour distribution	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	Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness of the STEP COACH intervention	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.	Baseline (before cardiac rehabilitation) to 12 months (follow-up)
Long-term clinical outcomes	All-cause mortality and major adverse cardiac events (MACE)	Baseline (before cardiac rehabilitation) to 15 years of follow-up

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Physical activity; Prevention; Cardiac rehabilitation; Consumer wearables; Step metrics
• Additional Relevant MeSH Terms: Vascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Behavior; Cardiovascular Diseases; Coronary Artery Disease; Motor Activity
• Other Study ID Numbers: 2026-19007; #03-002-2023-0036 (Other Grant/Funding Number: Dutch Heart Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In line with the Open Science initiative and FAIR principles, metadata of the study will be published on the Open Science Framework and IPD will be available on reasonable request via the corresponding author.
• IPD Sharing Time Frame: IPD will be availabe after publication of the results by the research team.
• IPD Sharing Access Criteria: All data will be stored in the Digital Research Environment (DRE, mydre. org), an online, cloud- based, globally available research platform. The DRE facilitates users to collaborate on research projects within the boundaries of data management regulations (General Data Protection Regulation and Good Clinical Practice compliant) in a flexible and safe way regarding security, Information and Communication Technology (ICT) infrastructure and audit trail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No