Cardiovascular Function and Physical Activity in COVID-19

Coronavirus 2019 Clinical Trial

— CV-COVID  

Official title:

Cardiovascular Implications and Physical Activity in Middle-age and Older People With a History of Coronavirus 2019 (COVID-19)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492552
• Other study ID #: P125303
• Status: Completed
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: May 11, 2023

Study information

• Verified date: August 2023
• Source: Coventry University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Coronavirus 2019
• Coronavirus Infections
• COVID-19

Intervention

Behavioral:
• Active-at-home-HF
Increase daily step count by 2,000 and weekly telephone calls.

Locations

Country	Name	City	State
United Kingdom	Coventry University	Coventry	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Coventry University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference and change in left ventricular global longitudinal strain.	Difference in left ventricular global longitudinal strain between COVID and non-COVID participants at rest and during peak exercise on baseline assessment.; 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.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in pulse wave velocity.	Difference in pulse wave velocity between COVID and non-COVID participants at baseline assessment.; Change in pulse wave velocity between COVID intervention and COVID usual care group at baseline and end of study assessments.; Pulse wave velocity (a measure of arterial stiffness) will be measured in meters per second (m/s) using a tonometer and sphygmomanometer.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in augmentation index.	Difference in augmentation index between COVID and non-COVID participants at baseline assessment.; Change in augmentation index between COVID intervention and COVID usual care group at baseline and end of study assessments.; Augmentation index (a measure of arterial stiffness) will be measured as percentage (%) using sphygmomanometer.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in resting cardiac output.	Difference in resting cardiac output between COVID and non-COVID participants at baseline assessment.; Change in resting cardiac output between COVID intervention and COVID usual care group at baseline and end of study assessments.; 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)
Secondary	Difference and change in maximal cardiac output.	Difference in maximal cardiac output between COVID and non-COVID participants at baseline assessment.; Change in maximal cardiac output between COVID intervention and COVID usual care group at baseline and end of study assessments.; 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)
Secondary	Difference and change in resting heart rate.	Difference in resting heart rate between COVID and non-COVID participants at baseline assessment.; Change in resting heart rate between COVID intervention and COVID usual care group at baseline and end of study assessments.; Heart rate (i.e. times the heart beats per minute) will be measured using non-invasive monitoring technology.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in maximal heart rate.	Difference in maximal heart rate between COVID and non-COVID participants at baseline assessment.; Change in maximal heart rate between COVID intervention and COVID usual care group at baseline and end of study assessments.; Heart rate (i.e. times the heart beats per minute) will be measured using non-invasive monitoring technology.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in resting stroke volume.	Difference in resting stroke volume between COVID and non-COVID participants at baseline assessment.; Change in resting stroke volume between COVID intervention and COVID usual care group at baseline and end of study assessments.; 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)
Secondary	Difference and change in maximal stroke volume.	Difference in maximal stroke volume between COVID and non-COVID participants at baseline assessment.; Change in maximal stroke volume between COVID intervention and COVID usual care group at baseline and end of study assessments.; 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)
Secondary	Difference and change in resting systemic vascular resistance.	Difference in resting systemic vascular resistance between COVID and non-COVID participants at baseline assessment.; Change in resting systemic vascular resistance between COVID intervention and COVID usual care group at baseline and end of study assessments.; 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)
Secondary	Difference and change in maximal systemic vascular resistance.	Difference in maximal systemic vascular resistance between COVID and non-COVID participants at baseline assessment.; Change in maximal systemic vascular resistance between COVID intervention and COVID usual care group at baseline and end of study assessments.; 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)
Secondary	Difference and change in maximal oxygen uptake (VO2 max).	Difference in VO2 max between COVID and non-COVID participants at baseline assessment.; Change in VO2 max between COVID intervention and COVID usual care group at baseline and end of study assessments.; VO2 max (i.e. maximal oxygen uptake) will be measured in milliliters per minute (mL/min).	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in Forced Expiratory Volume 1 (FEV1)/ forced vital capacity (FVC) ratio.	Difference in FEV/FEV1 ratio between COVID and non-COVID participants at baseline assessment.; Change in FEV/FEV1 ratio between COVID intervention and COVID usual care group at baseline and end of study assessments.; 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)
Secondary	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)
Secondary	Difference and change in depression, anxiety and stress measured on the DASS-21 questionnaire.	Difference in depression, anxiety and stress between COVID and non-COVID participants at baseline assessment.; Change in depression, anxiety and stress between COVID intervention and COVID usual care group at baseline and end of study assessments.; 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)
Secondary	Difference and change in global sleep efficiency.	Difference in global sleep efficiency between COVID and non-COVID participants at baseline assessment.; Change in global sleep efficiency between COVID intervention and COVID usual care group at baseline and end of study assessments.; 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)
Secondary	Change in sleep efficiency.	Difference in sleep efficiency between COVID and non-COVID participants at baseline assessment.; Change in sleep efficiency between COVID intervention and COVID usual care group at baseline and end of study assessments.; 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)
Secondary	Difference and change in right ventricular global longitudinal strain.	Difference in resting right ventricular global longitudinal strain between COVID and non-COVID participants at baseline assessment.; Change in resting right ventricular global longitudinal strain between COVID intervention and COVID usual care group at baseline and end of study assessments.; Right ventricular global longitudinal strain is measured as a percentage (%) using transthoracic echocardiography.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in left atrial strain.	Difference in left atrial strain between COVID and non-COVID participants at rest and during exercise on baseline assessment.; Change in left atrial strain between COVID intervention and COVID usual care group at rest and during exercise on baseline and end of study assessments.; Left atrial strain is measured as a percentage (%) using transthoracic echocardiography.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in ventricular arterial coupling.	Difference in ventricular arterial coupling between COVID and non-COVID participants on baseline assessment.; Change in ventricular arterial coupling between COVID intervention and COVID usual care group on baseline and end of study assessments.; 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)
Secondary	Difference and change in right ventricular diastolic function.	Difference in right ventricular diastolic function between COVID and non-COVID participants on baseline assessment.; Change in right ventricular diastolic function between COVID intervention and COVID usual care group on baseline and end of study assessments.; 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)
Secondary	Difference and change in electrocardiography (ECG) R-R interval average.	Difference in R-R average between COVID and non-COVID participants at rest on baseline assessment.; Change in R-R average between COVID intervention and COVID usual care group at rest on baseline and end of study assessments.; R-R average is a measurement of Heart Rate Variability, measured in milliseconds (ms) using electrocardiography.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in root mean square of successive ECG RR interval difference (RMSSD).	Difference in RMSSD between COVID and non-COVID participants at rest on baseline assessment.; Change in RMSSD between COVID intervention and COVID usual care group at rest on baseline and end of study assessments.; RMSSD is a measurement of Heart Rate Variability, measured in milliseconds (ms) using electrocardiography.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in Standard Deviation Normal RR Intervals (SDNN).	Difference in SDNN between COVID and non-COVID participants at rest on baseline assessment.; Change in SDNN between COVID intervention and COVID usual care group at rest on baseline and end of study assessments.; SDNN is a measurement of Heart Rate Variability, measured in milliseconds (ms) using electrocardiography.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in low-frequency power (LF).	Difference in LF between COVID and non-COVID participants at rest on baseline assessment.; Change in LF between COVID intervention and COVID usual care group at rest on baseline and end of study assessments.; LF (absolute power) is a measurement of Heart Rate Variability, measured in milliseconds squared (ms2) using electrocardiography.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in high-frequency power (HF).	Difference in HF between COVID and non-COVID participants at rest on baseline assessment.; Change in HF between COVID intervention and COVID usual care group at rest on baseline and end of study assessments.; HF (absolute power) is a measurement of Heart Rate Variability, measured in milliseconds squared (ms2) using electrocardiography.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in low-frequency power (LFnu).	Difference in LFnu between COVID and non-COVID participants at rest on baseline assessment.; Change in LFnu between COVID intervention and COVID usual care group at rest on baseline and end of study assessments.; LFnu (relative power) is a measurement of Heart Rate Variability, measured in normal units using electrocardiography.	12 weeks (baseline to 12 weeks)
Secondary	Difference and change in low-frequency power (HFnu).	Difference in HFnu between COVID and non-COVID participants at rest on baseline assessment.; Change in HFnu between COVID intervention and COVID usual care group at rest on baseline and end of study assessments.; HFnu (relative power) is a measurement of Heart Rate Variability, measured in normal units using electrocardiography.	12 weeks (baseline to 12 weeks)