Evaluation of Cardiac Rehabilitation Functional and Physical Capacity, Health-related Quality of Life and Associations With Frailty in Older Patients After Ischemic Heart Disease and Interventional Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frailty level by Edmonton frail scale score
研究概览
简要总结
The aim of this study is to evaluate functional and physical capacity, health-related quality of life and associations with frailty in older patients after ischemic heart disease and interventional treatment with an individualized physical training program in the second phase of cardiac rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after acute coronary syndrome and percutaneous coronary intervention or coronary bypass surgery;
- •Age 65 years and older;
- •6-minute walk distance (6-MWD) ≥150 meters;
- •Left ventricular ejection fraction ≥ 40%;
- •Patient's agreement to participate in the study.
排除标准
- •combined coronary artery bypass grafting and valve surgery;
- •Cardiac devices;
- •Diseases in the musculoskeletal system or other organs complicating physical activity and exercise training;
- •Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in cardiac rehabilitation according to study protocol), cognitive or linguistic deficits.
结局指标
主要结局
Frailty level by Edmonton frail scale score
时间窗: baseline
Frailty measured by The Edmonton frail scale score - 0-3 - fit, 4-5 - vulnerable, 6-7 - mild frailty, 8-9 - moderate frailty,10-17 - severe frailty.
Change from baseline quality of life by MacNew questionnaire
时间窗: baseline, 3 weeks
The MacNew Heart Disease HRQL questionnaire consists of 27 items which fall into three domains (a 13-item physical limitations domain scale, a 14-item emotional function domain scale, and a 13-item social function domain scale). There are 5 items that inquire about symptoms: angina/chest pain, shortness of breath, fatigue, dizziness, and aching legs. The time frame for the MacNew is the previous two weeks.
Change from baseline functional capacity by six minutes walking test (6MWT)
时间窗: baseline, 3 weeks
6MWT measured by meters
Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)
时间窗: baseline, 3 weeks
Maximal load measured with spiroergometry by maximal watts
Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
时间窗: baseline, 3 weeks
PeakVO2 measured with spiroergometry by millilitres of oxygen per kilogram of body mass per minute
次要结局
- Change from baseline physical performance by Short Physical Performance Battery (SPPB)(baseline, 3 weeks)
- Change from baseline muscular strength by one repetition maximum test (1RM)(baseline, 3 weeks)
研究者
Aurelija Beigienė
Aurelija Beigienė, MD
Lithuanian University of Health Sciences