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. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
334
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arnhem, Holland, 6815AD
- Rijnstate
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Nijmegen, Holland, 6525GA
- Radboud University Medical Center
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Nijmegen, Holland, 6532SZ
- Canisius Wilhelmina Ziekenhuis
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Uden, Holland, 5406PT
- Bernhoven
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Daily moderate-to-vigorous physical activity (min/day)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Daily moderate-to-vigorous physical activity (min/day)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Cost-effectiveness of the STEP COACH intervention
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
31. august 2028
Studieafslutning (Anslået)
31. august 2028
Datoer for studieregistrering
Først indsendt
20. juli 2026
Først indsendt, der opfyldte QC-kriterier
20. juli 2026
Først opslået (Faktiske)
23. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-19007
- #03-002-2023-0036 (Andet bevillings-/finansieringsnummer: Dutch Heart Foundation)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
IPD will be availabe after publication of the results by the research team.
IPD-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
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