Step Targets for Patients With Coronary Artery Disease: Towards Better Physical Activity Adherence Following Cardiac Rehab - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 334
- 试验地点
- 4
- 主要终点
- Daily moderate-to-vigorous physical activity (min/day)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
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).
干预措施: STEP COACH intervention group (Behavioral)
结局指标
主要结局
Daily moderate-to-vigorous physical activity (min/day)
时间窗: 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
次要结局
- Daily moderate-to-vigorous physical activity (min/day)(Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 12 months (follow-up))
- Distance covered during Interval Shuttle Walk Test (m)(Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program))
- Health-related quality of life(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(Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation) and 9 months (end of STEP COACH program))
- Daily step count (steps/day)(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)(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)(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(Baseline (before cardiac rehabilitation) to 3 months (end of cardiac rehabilitation), 9 months (end of STEP COACH program) and 12 months (follow-up))