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

NCT07723274 | Not Yet Recruiting

• 2 other identifiers: 2026-19007#03-002-2023-0036
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 4

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. 1.Control group who receives usual care (i.e., a 3-month cardiac rehabilitation program);
2. 2.STEP COACH group who receives usual care and the 9-month STEP COACH program.

Conditions

Coronary Artery Disease

Keywords

Cardiac rehabilitation; Cardiovascular disease; Physical activity; Prevention; Consumer wearables; Step metrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 12 months (follow-up)

• 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)

• 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)

• Stress (cortisol) levels

  Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)

• 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)

Other Outcomes (2)

• Cost-effectiveness of the STEP COACH intervention

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

• Long-term clinical outcomes

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

Study Arms (2)

Usual care group

NO INTERVENTION

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.

STEP COACH intervention group

EXPERIMENTAL

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

Interventions

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.

STEP COACH intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years of age or older;
• Able to understand and perform study related procedures.

You may not qualify if:

• Unable to give informed consent;
• Wheelchair-bound / not physically able to stand or walk;
• Language barrier;
• New York Heart Association class III or IV heart failure;
• Participation in another interventional study targeting physical activity;

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (4)

Rijnstate

Arnhem, 6815AD, Netherlands

Location

Radboud university medical center

Nijmegen, 6525GA, Netherlands

Location

Canisius Wilhelmina Ziekenhuis

Nijmegen, 6532SZ, Netherlands

Location

Bernhoven

Uden, 5406PT, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: IPD will be availabe after publication of the results by the research team.
• 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.

Locations

NL (4)