Cardiovascular Implications and Physical Activity in Middle-age and Older People With a History of Coronavirus 2019 (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Difference and change in left ventricular global longitudinal strain.
研究概览
简要总结
The purpose of this study is to a) assess how coronavirus 2019 (COVID-19) affects cardiac function in middle age and older adults and b) assess if a physical activity intervention (increased daily step count by 2,000) can affect cardiac function in a population with a history of COVID-19.
详细描述
Cardiac function will be assessed by obtaining arterial stiffness, comprehensive echocardiography measurements and haemodynamic monitoring. Arterial stiffness will assess primarily pulse wave velocity (PWV) and echocardiography. Graded cardiopulmonary exercise stress testing coupled with non-invasive gas exchange and haemodynamic monitoring will also be performed. Physical activity will be assessed objectively using pedometers and accelerometry. Quality of life, sleep/ circadian rhythm, fatigue, anxiety and depression will be measured using the validated Short-Form-36 (SF-36) questionnaire, Pittsburgh Sleep scale (PSQI), Chalder fatigue (CF) scale and the Depression, Anxiety and Stress Scale (DASS-21).
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
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 50-85 years old
- •Up to date with all COVID-19 vaccinations
- •COVID participants - had a positive test for COVID-19 over 28 days of initial visit but before 18 months. Non-COVID participants - never received a positive COVID-19 test result, and no symptoms during periods where testing was unavailable.
排除标准
- •Chronic respiratory and cardiovascular conditions i.e., chronic obstructive pulmonary disease (COPD), emphysema, pulmonary hypertension, coronary artery disease
- •Severe hypertension
- •Acute or chronic neurological impairment or progressive neurological disease
- •Use of medication known to directly affect cardiac function
- •Current smoker
- •Body mass index > 35 kg/m2
- •People who exceed current physical activity guidelines defined by the World Health Organization (WHO).
结局指标
主要结局
Difference and change in left ventricular global longitudinal strain.
时间窗: 12 weeks (baseline to 12 weeks)
1. Difference in left ventricular global longitudinal strain between COVID and non-COVID participants at rest and during peak exercise on baseline assessment. 2. Change in left ventricular global longitudinal strain between COVID intervention and COVID usual care group at rest and during peak exercise on baseline and end of study assessments. Left ventricular global longitudinal strain is measured as a percentage (%) using transthoracic echocardiography.
次要结局
- Difference and change in resting systemic vascular resistance.(12 weeks (baseline to 12 weeks))
- Difference and change in pulse wave velocity.(12 weeks (baseline to 12 weeks))
- Difference and change in resting heart rate.(12 weeks (baseline to 12 weeks))
- Difference and change in Forced Expiratory Volume 1 (FEV1)/ forced vital capacity (FVC) ratio.(12 weeks (baseline to 12 weeks))
- Difference and change in global sleep efficiency.(12 weeks (baseline to 12 weeks))
- Difference and change in maximal heart rate.(12 weeks (baseline to 12 weeks))
- Difference and change in resting stroke volume.(12 weeks (baseline to 12 weeks))
- Difference and change in maximal stroke volume.(12 weeks (baseline to 12 weeks))
- Difference and change in maximal oxygen uptake (VO2 max).(12 weeks (baseline to 12 weeks))
- Difference and change in ventricular arterial coupling.(12 weeks (baseline to 12 weeks))
- Difference and change in Standard Deviation Normal RR Intervals (SDNN).(12 weeks (baseline to 12 weeks))
- Difference and change in resting cardiac output.(12 weeks (baseline to 12 weeks))
- Difference and change in maximal systemic vascular resistance.(12 weeks (baseline to 12 weeks))
- Change in sleep efficiency.(12 weeks (baseline to 12 weeks))
- Difference and change in left atrial strain.(12 weeks (baseline to 12 weeks))
- Difference and change in augmentation index.(12 weeks (baseline to 12 weeks))
- Difference and change in maximal cardiac output.(12 weeks (baseline to 12 weeks))
- Change in quality of life measured by the SF-36 questionnaire between baseline and post intervention assessment at 12 weeks.(12 weeks (baseline to 12 weeks))
- Difference and change in depression, anxiety and stress measured on the DASS-21 questionnaire.(12 weeks (baseline to 12 weeks))
- Difference and change in low-frequency power (LFnu).(12 weeks (baseline to 12 weeks))
- Difference and change in low-frequency power (HFnu).(12 weeks (baseline to 12 weeks))
- Difference and change in right ventricular diastolic function.(12 weeks (baseline to 12 weeks))
- Difference and change in electrocardiography (ECG) R-R interval average.(12 weeks (baseline to 12 weeks))
- Difference and change in high-frequency power (HF).(12 weeks (baseline to 12 weeks))
- Difference and change in right ventricular global longitudinal strain.(12 weeks (baseline to 12 weeks))
- Difference and change in root mean square of successive ECG RR interval difference (RMSSD).(12 weeks (baseline to 12 weeks))
- Difference and change in low-frequency power (LF).(12 weeks (baseline to 12 weeks))
研究者
Djordje Jakovljevic
Principle Investigator
Coventry University