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 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
334
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Arnhem, Holandia, 6815AD
- Rijnstate
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Nijmegen, Holandia, 6525GA
- Radboud University Medical Center
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Nijmegen, Holandia, 6532SZ
- Canisius Wilhelmina Ziekenhuis
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Uden, Holandia, 5406PT
- Bernhoven
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Daily moderate-to-vigorous physical activity (min/day)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Daily moderate-to-vigorous physical activity (min/day)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Cost-effectiveness of the STEP COACH intervention
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 września 2026
Zakończenie podstawowe (Szacowany)
31 sierpnia 2028
Ukończenie studiów (Szacowany)
31 sierpnia 2028
Daty rejestracji na studia
Pierwszy przesłany
20 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
20 lipca 2026
Pierwszy wysłany (Rzeczywisty)
23 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
23 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
20 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026-19007
- #03-002-2023-0036 (Inny numer grantu/finansowania: Dutch Heart Foundation)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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.
Ramy czasowe udostępniania IPD
IPD will be availabe after publication of the results by the research team.
Kryteria dostępu do udostępniania 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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .