Effectiveness of Standardized Outpatient Cardiac Rehabilitation Program Combined With Power Walking on Quality of Life and Exercise Capacity in Patients With Post-coronary Angioplasty: A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Heart Quality of Life questionnaire global scores
研究概览
简要总结
The risk and prevalence of cardiovascular disease in United Arab Emirates (UAE) is high with ischemic heart disease ranks first in terms of major cause of mortality. Large number of patients undergoes coronary angioplasty but very few participate in cardiac rehabilitation because its awareness is not widespread in middle east region.
The objectives was to find the influence of standardized outpatient cardiac rehabilitation program along with power walking on Heart quality of life (Heart QoL), functional exercise capacity, Left Ventricular Ejection Fraction and metabolic equivalent task (MET's) among patients with post coronary angioplasty.
The investigators conducted a randomized clinical trail in out patient physiotherapy department at Thumbay hospitals Dubai, on patients who underwent coronary artery angioplasty. After meeting the inclusion criteria, participants were randomized into standardized outpatient cardiac rehabilitation program along with power walking (intervention group) or standardized outpatient cardiac rehabilitation program (control group).
A 4 weeks of 12 outpatient cardiac rehabilitation sessions consisting of 3 sessions per week was provided to both the groups. Intervention group received standardized outpatient cardiac rehabilitation program along with power walking based on targeted heart rate and weekly steps, whereas control group received only standardized outpatient cardiac rehabilitation program based on American College of Sports Medicine (ACSM) Guidelines.
The investigators measured Quality Of Life (HRQoL) by HeartQoL questionnaire, Exercise Capacity by 6 min walk test (6MWT), Left ventricle Ejection fraction (LVEF) using Echocardiogram, Metabolic Equivalent Task (MET'S) using Symptom-limited exercise stress test and Average number of steps walked daily using step up smartphone Pedometer App.
详细描述
Approximately 17.8 million worldwide deaths per year are due to cardiovascular disease (CVD). Arab countries are at higher risk of CVD in which middle income countries are mostly at burden. "The threshold for cardiac arrests and cardiovascular disease (CVD) worldwide is 65 years, while people in the UAE are suffering from the CVD at the age of 45" reported by Emirates Cardiac Society. One of the most common causes of cardiovascular deaths is coronary artery disease (CAD). Coronary angioplasty one of the most common non-surgical approach for the treatment of ischemic coronary artery disease. It is widely accepted that cardiac rehabilitation can be beneficial for patients with heart diseases. Most of the patients won't achieve adequate functional improvement, if rehabilitation exercises are not done on regular basis post-coronary angioplasty.
In cardiac rehabilitation (CR) programs, psychosocial function and the assessment of quality of life (QOL) are the major objective parameters commonly used by researchers. Physical activity and emotional status influence health related quality of life (HRQOL) in patient underwent coronary angioplasty. It is important to find effectiveness of CR on health related quality of life (HRQOL). Studies has shown that tailored exercise training helped to improve Left Ventricle Ejection Fraction (LVEF) in patients post coronary angioplasty. A systematic review highlighted the effectiveness of using 6MWT to show improvement of functional capacity in patients undergoing cardiac rehabilitation.
It is well known that walking exercise reduces cardiovascular disease-related mortality and predicts longevity in patients with established CAD. One of the integral components of cardiac rehabilitation is treadmill walking. A meta-analysis demonstrated that physical activity could be enhanced in patients with the use of pedometer. Recent evidence shows that smartphone apps are effective at promoting physical activity. Studies also shows that smartphone Apps are more accurate in tracking steps as compared to fitness trackers.
Power walking is an effective part of phase II cardiac rehabilitation. Running is preferred over walking since oxygen consumption while running is less as compared to walking.
It was reported that up to 1 year, cardiac rehabilitation improves QOL in patients with acute myocardial infarction (AMI) or revascularization procedures. Four weeks of short CR course provides better attendance, improvement in quality of life and exercise capacity.
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
- Double (Participant, Investigator)
盲法说明
For each participant were blinded till allocation of treatment. Investigator was also blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those patients underwent coronary angioplasty and willing to participate
- •Age between 18-70 years.
- •Both the genders.
- •Patients who completed not < 2 week and not >12 weeks post hospital discharge.
- •Patients not limited to diabetes mellitus, controlled Hypertension, Hyperlipidemia and obese.
- •Availability of smart phone.
排除标准
- •Malignancy.
- •Neurological disorders.
- •Psychoneurotic disorders Causing deficit in functioning.
- •Significant valvular diseases.
- •Active pericarditis or myocarditis.
- •Patient with complications related to angioplasty procedure.
- •Severe orthostatic hypotension.
- •Severe obstructive airway disease or any other chronic pulmonary disorder.
- •Physically disabled patients.
- •All Musculoskeletal disorders affecting movement of bilateral upper and lower limbs while walking at a faster speed of 6 to 8 km/h (47)
- •Patients contraindicated for exercises testing and training.
- •Severe uncontrolled hypertension (Systolic Blood Pressure >180 mmHg and/or Diastolic Blood Pressure >100 mmHg).
结局指标
主要结局
Heart Quality of Life questionnaire global scores
时间窗: From the start of treatment i.e., Day 1, Base line assessment until 4th week, i.e., completion of 12th therapy session
HeartQoL questionnaire has 14-items with two subscales consisting of 10 and 4 -item of physical and emotional subscales respectively. Subscale scores are summarised to global scores. Standard deviation scores specific to population mean were used for statistical analysis.
次要结局
- Walking steps per day measured by pedometer(From the start of treatment i.e., Day 1, Base line assessment until 4th week, i.e., completion of 12th therapy session)
- Energy expenditure measured in Metabolic equivalent of task (MET)(From the start of treatment i.e., Day 1, Base line assessment until 4th week, i.e., completion of 12th therapy session)
- Six Minute Walk Test (6MWT) distance in meters(From the start of treatment i.e., Day 1, Base line assessment until 4th week, i.e., completion of 12th therapy session)
- Percentage of Left ventricle Ejection fraction (LVEF) i.e., Percentage of blood pumped out of left ventricle during each contraction.(From the start of treatment i.e., Day 1, Base line assessment until 4th week, i.e., completion of 12th therapy session)