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

Official title

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

Overview

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

• 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 smar

Primary outcome measures

• Daily moderate-to-vigorous physical activity (min/day) [Time frame: Baseline (before cardiac rehabilitation) to 9 months (end of STEP COACH program)]

Secondary outcome measures (8)

• 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)]
• 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)]
• 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)]
• Stress (cortisol) levels [Time frame: Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)]
• 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)]
• 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)]
• 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)]
• 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)]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Netherlands · 4 centers

• Rijnstate — Arnhem
• Radboud university medical center — Nijmegen
• Canisius Wilhelmina Ziekenhuis — Nijmegen
• Bernhoven — Uden

Identifiers

NCT: NCT07723274 · 2026-19007 · #03-002-2023-0036

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗