A Randomized Controlled Trial to Evaluate Utilization of Physical Activity Recommendations Among Patients of Cardiovascular Healthcare Centres in Eastern Slovakia: Study Design and Rationale of the AWATAR Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in exercise recommendations compliance at three months
研究概览
简要总结
The aims of this trial are:
(A) to determine and compare the indices of exercise recommendations compliance after exercise prescription according to digital training and decision support system as compared to exercise prescription following the standard informative procedure among patients with cardiovascular disease.
(B) to determine whether health literacy moderates effect of exercise prescription according to digital training and decision support system on the indices of exercise recommendations compliance among patients with cardiovascular disease.
详细描述
The trial will compare the utilization of physical activity recommendation between the standard lifestyle informative procedure and the digital training and decision system informative procedure.
We hypothesize that a higher rate of compliance between seven-day exercise report and physical activity recommendations will be observed in the experimental group compared with three-months waiting group.
The goal is to recruit patients with a stable diagnosis, clinically defined as sufficiently healthy to participate in an optimized (safe and monitored) exercise programme. Based on the experience with similar projects completed on Cardiovascular Health Centres (CHC) expected attrition rate is 25%. Such a value and 400 participants as a target recruitment number still allows to keep 150 participants in both groups and a power of 80% to detect the differences between groups and across the time at an α level of 0,05 (two-tailed).
The trial will be supervised by a Data Safety and Monitoring Board consisting of one independent, internationally recognized clinical researcher, one representative (cardiologist) from each cooperating Cardiovascular Healthcare Centre as an advisor and experts in health psychology, exercise psychology, trial management and exercise physiology. The Board will be the policy and decision-making authority of the trial.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •receive information about perceived health benefits and risks connected with participation in the study based on disease severity from the treating cardiologist about participation in the study,
- •willingness to accept randomization and participation in the assessment procedures,
- •at recruitment moment, medical record of one or more below-listed cardiovascular diagnosis: coronary artery disease, coronary artery bypass graft surgery, or endoscopic traumatic coronary artery bypass graft surgery, compensated heart failure, cardiomyopathy, intermittent claudication, implantable cardioverter defibrillator or pacemaker, ventricular assist devices, heart transplantation, valve disease or surgery, congenital heart disease and non-severe pulmonary hypertension.
排除标准
- •include the presence of below-listed specific cardiovascular conditions, significantly increasing risks of sudden cardiovascular events, also identified as potential contraindications of physical activity on cardiovascular patients: uncontrolled hypertension, decompensated heart failure, severe and symptomatic aortic stenosis, uncontrolled arrhythmia, severe pulmonary hypertension, acute coronary syndromes, acute myocarditis, endocarditis, or pericarditis, aortic dissection, Marfan syndrome or presence of malignancy (active cancer) or life-treating disease, bed-ridden status, participation or plan to participate in other study during trial execution or plan to move during the trial execution.
研究组 & 干预措施
Experimental group
Patients randomized into the experimental group will undergo behavioural counselling. During the 30-minute long consultation patients will receive standard, usual-cardio-care lifestyle, hypertension and cardiovascular instructions, except recommendations for physical activities. This domain will be consulted exclusively through the digital training and decision support system EXPERT tool.
干预措施: The EAPC Exercise Prescription (EXPERT) Tool (Behavioral)
Control group
Patients randomized into the control group will receive standard, usual-cardio-care lifestyle, hypertension and cardiovascular instructions, also in the domain of recommendations for physical activities.
干预措施: Standard Cardio-Care Lifestyle Counselling (Behavioral)
结局指标
主要结局
Change in exercise recommendations compliance at three months
时间窗: Before the intervention and 1-5 days after three months follow up
Compliance will be determined as agreement between indices of exercise prescription delivered by EXPERT tool and self-reported indices of exercise performed in monitoring periods (1 year and 7 days period).
次要结局
- Change in body height at three months(Before the intervention and 1-5 days after three months follow up)
- Change in body weight at three months(Before the intervention and 1-5 days after three months follow up)
- Change in Body Mass Index at three months(Before the intervention and 1-5 days after three months follow up)
- Change in clinical data at three months(Before the intervention and 1-5 days after three months follow up)
- Change in health literacy at three months(Before the intervention and 1-5 days after three months follow up)
- Change in leisure time physical activities at three months(Before the intervention and 1-5 days after three months follow up)
研究者
Aurel Zelko
Institute of Physical Education and Sport
Pavol Jozef Safarik University