Skip to main content
OpenTrials
Completed

NCT Number: NCT05492552

Cardiovascular Function and Physical Activity in COVID-19

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronavirus 2019 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coventry University

Coventry, West Midlands, CV1 2DS, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Active-at-home-HF

Behavioral

Increase daily step count by 2,000 and weekly telephone calls.

Primary outcomes

  1. Difference and change in left ventricular global longitudinal strain.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

Secondary outcomes

  1. Difference and change in pulse wave velocity.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  2. Difference and change in augmentation index.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  3. Difference and change in resting cardiac output.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  4. Difference and change in maximal cardiac output.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  5. Difference and change in resting heart rate.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  6. Difference and change in maximal heart rate.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  7. Difference and change in resting stroke volume.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  8. Difference and change in maximal stroke volume.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  9. Difference and change in resting systemic vascular resistance.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  10. Difference and change in maximal systemic vascular resistance.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  11. Difference and change in maximal oxygen uptake (VO2 max).

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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. Difference and change in Forced Expiratory Volume 1 (FEV1)/ forced vital capacity (FVC) ratio.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  13. Change in quality of life measured by the SF-36 questionnaire between baseline and post intervention assessment at 12 weeks.

    Time frame: 12 weeks (baseline to 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.

  14. Difference and change in depression, anxiety and stress measured on the DASS-21 questionnaire.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  15. Difference and change in global sleep efficiency.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  16. Change in sleep efficiency.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  17. Difference and change in right ventricular global longitudinal strain.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  18. Difference and change in left atrial strain.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  19. Difference and change in ventricular arterial coupling.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  20. Difference and change in right ventricular diastolic function.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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)).

  21. Difference and change in electrocardiography (ECG) R-R interval average.

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  22. Difference and change in root mean square of successive ECG RR interval difference (RMSSD).

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  23. Difference and change in Standard Deviation Normal RR Intervals (SDNN).

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  24. Difference and change in low-frequency power (LF).

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  25. Difference and change in high-frequency power (HF).

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  26. Difference and change in low-frequency power (LFnu).

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

  27. Difference and change in low-frequency power (HFnu).

    Time frame: 12 weeks (baseline to 12 weeks)

    • 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.

Sponsors and collaborators

Lead sponsor

Coventry University

Other

Registry information

Official study title

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

Acronym: CV-COVID

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2022
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.