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)
20 de julio de 2026 actualizado por: Radboud University Medical Center
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:
- 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
334
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arnhem, Países Bajos, 6815AD
- Rijnstate
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Nijmegen, Países Bajos, 6525GA
- Radboud University Medical Center
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Nijmegen, Países Bajos, 6532SZ
- Canisius Wilhelmina Ziekenhuis
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Uden, Países Bajos, 5406PT
- Bernhoven
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: 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.
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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).
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Daily moderate-to-vigorous physical activity (min/day)
Periodo de tiempo: Baseline (before cardiac rehabilitation) to 9 months (end of STEP COACH program)
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Change in moderate-to-vigorous physical activity time, measured using a thigh-worn accelerometer over 7 days
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Baseline (before cardiac rehabilitation) to 9 months (end of STEP COACH program)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Daily moderate-to-vigorous physical activity (min/day)
Periodo de tiempo: Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 12 months (follow-up)
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Changes in moderate-to-vigorous physical activity time, measured using a thigh-worn accelerometer over 7 days
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Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 12 months (follow-up)
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Distance covered during Interval Shuttle Walk Test (m)
Periodo de tiempo: Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
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Changes in total distance covered (m) during the interval shuttle walk test, a measure for functional capacity
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Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
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Health-related quality of life
Periodo de tiempo: Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
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Changes in health-related quality of life (physical, emotional and social domain) will be assessed with the MacNew questionnaire.
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Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
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Stress (cortisol) levels
Periodo de tiempo: Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
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Changes in cortisol levels, measured by hair sampling from the occipital region.
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Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
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Daily step count (steps/day)
Periodo de tiempo: Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
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Changes in number of steps/day, measured using a thigh-worn accelerometer over 7 days
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Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
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Peak 30-min cadence (steps/min)
Periodo de tiempo: Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
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Changes in peak 30-min cadence (steps/min), measured using a thigh-worn accelerometer over 7 days
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Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
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Time at moderate-to-vigorous walking cadence (min)
Periodo de tiempo: Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
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Changes in daily time at moderate-to-vigorous walking cadence (i.e., >100 steps/min), measured using a thigh-worn accelerometer over 7 days
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Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
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24-hour movement behaviour distribution
Periodo de tiempo: Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
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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
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Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cost-effectiveness of the STEP COACH intervention
Periodo de tiempo: Baseline (before cardiac rehabilitation) to 12 months (follow-up)
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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.
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Baseline (before cardiac rehabilitation) to 12 months (follow-up)
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Long-term clinical outcomes
Periodo de tiempo: Baseline (before cardiac rehabilitation) to 15 years of follow-up
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All-cause mortality and major adverse cardiac events (MACE)
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Baseline (before cardiac rehabilitation) to 15 years of follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
31 de agosto de 2028
Finalización del estudio (Estimado)
31 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
20 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de julio de 2026
Publicado por primera vez (Actual)
23 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-19007
- #03-002-2023-0036 (Otro número de subvención/financiamiento: Dutch Heart Foundation)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
IPD will be availabe after publication of the results by the research team.
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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