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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-COVID participants | No Intervention | ||
| COVID participants in intervention | Experimental | The intervention group will attend the laboratory for baseline testing and complete a week of usual daily activity. Following this week they will then be guided to increase their daily step count by 2,000 and supported through weekly telephone calls. |
|
| COVID participants assigned to usual daily activity | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active-at-home-HF | Behavioral | Increase daily step count by 2,000 and weekly telephone calls. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference and change in left ventricular global longitudinal strain. |
Left ventricular global longitudinal strain is measured as a percentage (%) using transthoracic echocardiography. | 12 weeks (baseline to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference and change in pulse wave velocity. |
Pulse wave velocity (a measure of arterial stiffness) will be measured in meters per second (m/s) using a tonometer and sphygmomanometer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coventry University | Coventry | West Midlands | CV1 2DS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37179415 | Derived | Rahman M, Russell SL, Okwose NC, Hood OMA, Harwood AE, McGregor G, Raleigh SM, Sandhu H, Roden LC, Maddock H, Banerjee P, Jakovljevic DG. Cardiovascular implications and physical activity in middle-aged and older adults with a history of COVID-19 (CV COVID): a protocol for a randomised controlled trial. Trials. 2023 May 13;24(1):328. doi: 10.1186/s13063-023-07360-7. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 12 weeks (baseline to 12 weeks) |
| Difference and change in augmentation index. |
Augmentation index (a measure of arterial stiffness) will be measured as percentage (%) using sphygmomanometer. | 12 weeks (baseline to 12 weeks) |
| Difference and change in resting cardiac output. |
Cardiac output (i.e. volume of blood ejected from the heart) will be measured in litres per minute (L/min) using non-invasive monitoring technology. | 12 weeks (baseline to 12 weeks) |
| Difference and change in maximal cardiac output. |
Cardiac output (i.e. volume of blood ejected from the heart) will be measured in litres per minute (L/min) using non-invasive monitoring technology. | 12 weeks (baseline to 12 weeks) |
| Difference and change in resting heart rate. |
Heart rate (i.e. times the heart beats per minute) will be measured using non-invasive monitoring technology. | 12 weeks (baseline to 12 weeks) |
| Difference and change in maximal heart rate. |
Heart rate (i.e. times the heart beats per minute) will be measured using non-invasive monitoring technology. | 12 weeks (baseline to 12 weeks) |
| Difference and change in resting stroke volume. |
Stroke volume (i.e. volume of blood pumped out of the heart in one beat) will be measured in liters (L) using non-invasive monitoring technology. | 12 weeks (baseline to 12 weeks) |
| Difference and change in maximal stroke volume. |
Stroke volume (i.e. volume of blood pumped out of the heart in one beat) will be measured in liters (L) using non-invasive monitoring technology. | 12 weeks (baseline to 12 weeks) |
| Difference and change in resting systemic vascular resistance. |
Systemic vascular resistance (i.e. the force exerted on circulating blood by the vasculature of the body) will be measured in mmHg⋅min/mL using non-invasive monitoring technology. | 12 weeks (baseline to 12 weeks) |
| Difference and change in maximal systemic vascular resistance. |
Systemic vascular resistance (i.e. the force exerted on circulating blood by the vasculature of the body) will be measured in mmHg⋅min/mL using non-invasive monitoring technology. | 12 weeks (baseline to 12 weeks) |
| Difference and change in maximal oxygen uptake (VO2 max). |
VO2 max (i.e. maximal oxygen uptake) will be measured in milliliters per minute (mL/min). | 12 weeks (baseline to 12 weeks) |
| Difference and change in Forced Expiratory Volume 1 (FEV1)/ forced vital capacity (FVC) ratio. |
FEV/FEV1 ratio (i.e. the ratio that reflects the amount of air you can forcefully exhale from your lungs) will be measured using spirometry. | 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. | Difference in quality of life 36 Item Short Form survey scores between baseline and end of study assessments.Score ranges from 0-100, with higher scores associated with a better outcome. | 12 weeks (baseline to 12 weeks) |
| Difference and change in depression, anxiety and stress measured on the DASS-21 questionnaire. |
Depression, anxiety and stress measured on the DASS-21 questionnaire. Score ranges from 0-56, with higher scores associated with a worse outcome. | 12 weeks (baseline to 12 weeks) |
| Difference and change in global sleep efficiency. |
Sleep efficiency is measured on the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Score ranges from 0-21, with higher scores associated with a worse outcome. | 12 weeks (baseline to 12 weeks) |
| Change in sleep efficiency. |
Sleep efficiency is measured using the Condor Actigraph watch. Score ranges from 0-100%, with higher scores associated with a higher sleep efficiency. | 12 weeks (baseline to 12 weeks) |
| Difference and change in right ventricular global longitudinal strain. |
Right ventricular global longitudinal strain is measured as a percentage (%) using transthoracic echocardiography. | 12 weeks (baseline to 12 weeks) |
| Difference and change in left atrial strain. |
Left atrial strain is measured as a percentage (%) using transthoracic echocardiography. | 12 weeks (baseline to 12 weeks) |
| Difference and change in ventricular arterial coupling. |
Ventricular arterial coupling (VAC) is a ratio which is calculated using the formula VAC = Ea/Ees; where Ea = arterial elastance (0.9 x systolic blood pressure/ stroke volume) and Ees = ventricular elastance (0.9 x systolic blood pressure/ left ventricular end systolic volume (LVESV). stroke volume and LVESV are both calculated using echocardiography techniques. | 12 weeks (baseline to 12 weeks) |
| Difference and change in right ventricular diastolic function. |
Right ventricular diastolic function has no particular units, rather is graded impaired or restrictive right ventricular filling using several echocardiographic measurements i.e., tricuspid valve E:A ratio, tricuspid valve deceleration time (milliseconds (ms)). | 12 weeks (baseline to 12 weeks) |
| Difference and change in electrocardiography (ECG) R-R interval average. |
R-R average is a measurement of Heart Rate Variability, measured in milliseconds (ms) using electrocardiography. | 12 weeks (baseline to 12 weeks) |
| Difference and change in root mean square of successive ECG RR interval difference (RMSSD). |
RMSSD is a measurement of Heart Rate Variability, measured in milliseconds (ms) using electrocardiography. | 12 weeks (baseline to 12 weeks) |
| Difference and change in Standard Deviation Normal RR Intervals (SDNN). |
SDNN is a measurement of Heart Rate Variability, measured in milliseconds (ms) using electrocardiography. | 12 weeks (baseline to 12 weeks) |
| Difference and change in low-frequency power (LF). |
LF (absolute power) is a measurement of Heart Rate Variability, measured in milliseconds squared (ms2) using electrocardiography. | 12 weeks (baseline to 12 weeks) |
| Difference and change in high-frequency power (HF). |
HF (absolute power) is a measurement of Heart Rate Variability, measured in milliseconds squared (ms2) using electrocardiography. | 12 weeks (baseline to 12 weeks) |
| Difference and change in low-frequency power (LFnu). |
LFnu (relative power) is a measurement of Heart Rate Variability, measured in normal units using electrocardiography. | 12 weeks (baseline to 12 weeks) |
| Difference and change in low-frequency power (HFnu). |
HFnu (relative power) is a measurement of Heart Rate Variability, measured in normal units using electrocardiography. | 12 weeks (baseline to 12 weeks) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |