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NCT07723274

Overview

NCT ID: NCT07723274
Lead Sponsor: Radboud University Medical CenterOTHER
Official Title: Step Targets for Patients With Coronary Artery Disease: Towards Better Physical Activity Adherence Following Cardiac Rehab - A Randomised Controlled Trial
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:

Control group who receives usual care (i.e., a 3-month cardiac rehabilitation program);

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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Aug 31, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Type: Interventional
Phase: Not Applicable
Enrollment: 334Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Rijnstate

Similar Studies

Participant Group/Arms

Usual care groupNo 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 groupExperimental

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