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Coronavirus 2019CV-COVIDNCT05492552

Cardiovascular Function and Physical Activity in COVID-19

A study testing Active-at-home-HF in people with Coronavirus 2019, run by Coventry University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Coronavirus 2019
What is being tested?
Active-at-home-HF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteUnited Kingdom
Study dates
7 Apr 2022to 11 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Coventry University

    Coventry, West Midlands, CV1 2DS

Other trials in United Kingdom

About this study

Official title: Cardiovascular Implications and Physical Activity in Middle-age and Older People With a History of Coronavirus 2019 (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.

Read the detailed 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).

Being tested
Active-at-home-HF
Keywords
Coronavirus 2019, Cardiovascular System, Arterial Stiffness, Echocardiography, Cardiopulmonary exercise stress testing, COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active-at-home-HFBehavioural

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

Study groups in NCT05492552
Study groupRoleWhat they receive
Non-COVID participantsNo interventionNot described
COVID participants in interventionExperimentalThe 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.
Receives: Behavioral: Active-at-home-HF
COVID participants assigned to usual daily activityNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 12 weeks (baseline to 12 weeks)

Secondary outcomes (27)

  1. Difference and change in pulse wave velocity.

    1. Difference in pulse wave velocity between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  2. Difference and change in augmentation index.

    1. Difference in augmentation index between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  3. Difference and change in resting cardiac output.

    1. Difference in resting cardiac output between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  4. Difference and change in maximal cardiac output.

    1. Difference in maximal cardiac output between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  5. Difference and change in resting heart rate.

    1. Difference in resting heart rate between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  6. Difference and change in maximal heart rate.

    1. Difference in maximal heart rate between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  7. Difference and change in resting stroke volume.

    1. Difference in resting stroke volume between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  8. Difference and change in maximal stroke volume.

    1. Difference in maximal stroke volume between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  9. Difference and change in resting systemic vascular resistance.

    1. Difference in resting systemic vascular resistance between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  10. Difference and change in maximal systemic vascular resistance.

    1. Difference in maximal systemic vascular resistance between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

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

    1. Difference in VO2 max between COVID and non-COVID participants at baseline assessment.
    2. 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).

    Measured: 12 weeks (baseline to 12 weeks)

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

    1. Difference in FEV/FEV1 ratio between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  13. 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.

    Measured: 12 weeks (baseline to 12 weeks)

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

    1. Difference in depression, anxiety and stress between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  15. Difference and change in global sleep efficiency.

    1. Difference in global sleep efficiency between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  16. Change in sleep efficiency.

    1. Difference in sleep efficiency between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

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

    1. Difference in resting right ventricular global longitudinal strain between COVID and non-COVID participants at baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  18. Difference and change in left atrial strain.

    1. Difference in left atrial strain between COVID and non-COVID participants at rest and during exercise on baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  19. Difference and change in ventricular arterial coupling.

    1. Difference in ventricular arterial coupling between COVID and non-COVID participants on baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

  20. Difference and change in right ventricular diastolic function.

    1. Difference in right ventricular diastolic function between COVID and non-COVID participants on baseline assessment.
    2. 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)).

    Measured: 12 weeks (baseline to 12 weeks)

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

    1. Difference in R-R average between COVID and non-COVID participants at rest on baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

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

    1. Difference in RMSSD between COVID and non-COVID participants at rest on baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

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

    1. Difference in SDNN between COVID and non-COVID participants at rest on baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

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

    1. Difference in LF between COVID and non-COVID participants at rest on baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

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

    1. Difference in HF between COVID and non-COVID participants at rest on baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

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

    1. Difference in LFnu between COVID and non-COVID participants at rest on baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

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

    1. Difference in HFnu between COVID and non-COVID participants at rest on baseline assessment.
    2. 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.

    Measured: 12 weeks (baseline to 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2022
  2. Study start7 Apr 2022
  3. Primary completion11 May 2023
  4. Study completion11 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05492552
Sponsor's protocol ID
P125303
Acronym
CV-COVID
Status last verified
Aug 2023
First submitted
3 Aug 2022
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37179415

Questions about this trial

What is this clinical trial studying?

A study testing Active-at-home-HF in people with Coronavirus 2019, run by Coventry University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference and change in left ventricular global longitudinal strain. (time frame: 12 weeks (baseline to 12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05492552, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.

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