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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)

2026年7月20日 更新者：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:

  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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

334

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 荷兰
      • Arnhem、荷兰、6815AD
        • Rijnstate
      • Nijmegen、荷兰、6525GA
        • Radboud University Medical Center
      • Nijmegen、荷兰、6532SZ
        • Canisius Wilhelmina Ziekenhuis
      • Uden、荷兰、5406PT
        • Bernhoven

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：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.
实验性的：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).
行为的：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 smartphone to track and evaluate their habitual physical activity via an online platform.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Daily moderate-to-vigorous physical activity (min/day)
大体时间：Baseline (before cardiac rehabilitation) to 9 months (end of STEP COACH program)
Change in moderate-to-vigorous physical activity time, measured using a thigh-worn accelerometer over 7 days
Baseline (before cardiac rehabilitation) to 9 months (end of STEP COACH program)

次要结果测量

结果测量
措施说明
大体时间
Daily moderate-to-vigorous physical activity (min/day)
大体时间：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 12 months (follow-up)
Changes in moderate-to-vigorous physical activity time, measured using a thigh-worn accelerometer over 7 days
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 12 months (follow-up)
Distance covered during Interval Shuttle Walk Test (m)
大体时间：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
Changes in total distance covered (m) during the interval shuttle walk test, a measure for functional capacity
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
Health-related quality of life
大体时间：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Changes in health-related quality of life (physical, emotional and social domain) will be assessed with the MacNew questionnaire.
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
大体时间：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
Changes in cortisol levels, measured by hair sampling from the occipital region.
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program)
Daily step count (steps/day)
大体时间：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Changes in number of steps/day, measured using a thigh-worn accelerometer over 7 days
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)
大体时间：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Changes in peak 30-min cadence (steps/min), measured using a thigh-worn accelerometer over 7 days
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)
大体时间：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
Changes in daily time at moderate-to-vigorous walking cadence (i.e., >100 steps/min), measured using a thigh-worn accelerometer over 7 days
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
大体时间：Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)
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
Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up)

其他结果措施

结果测量
措施说明
大体时间
Cost-effectiveness of the STEP COACH intervention
大体时间：Baseline (before cardiac rehabilitation) to 12 months (follow-up)
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.
Baseline (before cardiac rehabilitation) to 12 months (follow-up)
Long-term clinical outcomes
大体时间：Baseline (before cardiac rehabilitation) to 15 years of follow-up
All-cause mortality and major adverse cardiac events (MACE)
Baseline (before cardiac rehabilitation) to 15 years of follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Radboud University Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年8月31日

研究完成 (估计的)

2028年8月31日

研究注册日期

首次提交

2026年7月20日

首先提交符合 QC 标准的

2026年7月20日

首次发布 (实际的)

2026年7月23日

研究记录更新

最后更新发布 (实际的)

2026年7月23日

上次提交的符合 QC 标准的更新

2026年7月20日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-19007
  • #03-002-2023-0036 (其他赠款/资助编号：Dutch Heart Foundation)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

IPD will be availabe after publication of the results by the research team.

IPD 共享访问标准

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 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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