Transmural Physical Activity Monitoring and Guidance During Phase 3 Cardiac Rehabilitation: the Antwerp Activity Index
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 318
- 试验地点
- 2
- 主要终点
- Objective moderate-to-vigorous physical activity performance adherence
研究概览
简要总结
The goal of this clinical trial is to determine whether the AAI activity score can help cardiac rehabilitation patients adhere to physical activity guidelines after participating in an in-hospital cardiac rehabilitation program. The main questions it aims to answer are:
- Does the AAI activity score have an impact on adherence to physical activity maintenance during phase 3 CR?
- Does the AAI activity score predict changes in cardiorespiratory fitness? Researchers will compare participants who use the AAI activity score with those who do not to determine if there are differences in physical activity adherence.
Participants will:
- Wear a smartwatch to continuously measure heart rate for 4 months;
- Perform an exercise stress test at the end of the study;
- Fill in several questionnaires at the end of the study.
详细描述
Adopting and maintaining an active lifestyle after phase 2 cardiac rehabilitation (CR) is crucial for cardiac patients. Tools to provide an active transition from phase 2 CR to phase 3 CR are lacking, resulting in negative changes in physical activity (PA) behaviour, cardiovascular risk profiles and cardiorespiratory fitness (CRF) levels. The researchers developed a procedure that calculates a PA-score (Antwerp Activity Index; AAI) based on reliable heart rate (HR) data collected by commercially available heart rate monitors (HRMs), which is designed to reflect changes in CRF. This procedure could serve as a valuable tool to facilitate a more active transition from phase 2 CR to phase 3 CR. Ultimately, positively influencing CR patients' PA levels (and possibly) cardiovascular and overall health-related outcomes.
This study will collect HR data with the Fitbit Versa 4 smartwatch and Polar H10 chest strap with the aim of:
Goal 1. Assessing the effect of our AAI-score intervention on adherence towards physical activity maintenance of post-phase 2 CR patients during phase 3 CR.
Goal 2. Assessing the potential differences in the participants' self-experienced physical activity and objectively measured physical activity.
Goal 3. Investigating the correlation between adherence to our AAI score and changes in CRF.
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
- None
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
- •Age ≥ 18 years,
- •Patients in the last phase of phase 2 CR,
- •Having a smartphone available,
- •Being capable of signing the informed consent.
排除标准
- •Patients with high-risk criteria for safe exercise participation following a cardiac event, including:
- •Ejection fraction less than 30%
- •Decrease in systolic blood pressure of more than 15 mmHg with exercise
- •Serious arrhythmias at rest or exercise-induced
- •Exercise-induced ischemia indicated by angina more than 2 mm ST segment depression on the ECG
- •Patients with severe heart failure (NYHA III-IV),
- •Patients with implantable devices (e.g. pacemakers),
- •Patients diagnosed with permanent AF,
- •Patients who do not speak and read Dutch or English,
- •Patients who have cognitive impairment (e.g. severe dementia).
研究组 & 干预措施
AAI usage through personalised target
Participants are instructed to continuously wear a Fitbit Versa 4 smartwatch for the whole monitoring period, sync the data daily via the Fitbit application, and charge the device when needed. The intervention group has access to the generated AAI scores through a study application. During an initiation visit, they will be informed about how the score works and its purpose. They will receive tailored targets to adhere to. This group will also receive semi-automatic feedback reports through the study application. Feedback will be provided every two weeks for the first two months and once more at the end of the third month. No feedback will be given during the last month of follow-up.
干预措施: Activity score (Device)
Blinded AAI data collection
Participants are instructed to continuously wear a Fitbit Versa 4 smartwatch for the whole monitoring period, sync the data daily via the Fitbit application, and charge the device when needed. They can use the device to their liking. They do not have access to the AAI algorithm, nor will they receive feedback through the study application.
结局指标
主要结局
Objective moderate-to-vigorous physical activity performance adherence
时间窗: From enrollment to the end of treatment at 4 months
The primary aim of this study is to assess the impact of using the developed AAI score on adherence to moderate-to-vigorous pysical activity (MVA) during phase 3 CR. This will be objectively measured and analysed by calculating the number of minutes per week a participant spends above the threshold for moderate-to-vigorous physical activity, determined using individualised heart rate zones derived from cardiopulmonary exercise testing (CPET). Continuous heart rate data (collected using the Fitbit device) are used to calculate total MVPA minutes per week.
Subjective moderate-to-vigorous physical activity performance adherence
时间窗: From enrollment to the end of treatment at 4 months
At the end of the study, during the final study visit, researchers will question participants on their PA over the last 14 days using the International Physical Activity Questionnaire (IPAQ), a validated instrument for measuring short-term PA behaviour. The responses are used to calculate an activity level in Metabolic Equivalent of Task (MET)-minutes per week.
次要结局
- Difference in MET-minutes/week in objectively measured physical activity and subjectively reported physical activity.(From enrollment to the end of treatment at 4 months.)
- Correlation between adherence to AAI score and cardiorespiratory fitness changes, as measured by VO2peak.(from entrollment to the end of treatment at 4 months.)
- Percentage of days participants adhere to AAI score target.(From enrollment to the end of treatment at 4 months.)
- Activity score influence on AF burden and recurrence.(From enrollment to the end of treatment at 4 months.)