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Cardiovascular Function and Physical Activity in COVID-19 (CV-COVID)

Primary Purpose

Coronavirus 2019

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Active-at-home-HF
Sponsored by
Coventry University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus 2019 focused on measuring Coronavirus 2019, Cardiovascular System, Arterial Stiffness, Echocardiography, Cardiopulmonary exercise stress testing, COVID-19

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Coventry University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Non-COVID participants

COVID participants in intervention

COVID participants assigned to usual daily activity

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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)).
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 3, 2022
Last Updated
August 30, 2023
Sponsor
Coventry University
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1. Study Identification

Unique Protocol Identification Number
NCT05492552
Brief Title
Cardiovascular Function and Physical Activity in COVID-19
Acronym
CV-COVID
Official Title
Cardiovascular Implications and Physical Activity in Middle-age and Older People With a History of Coronavirus 2019 (COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
May 11, 2023 (Actual)
Study Completion Date
May 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coventry University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus 2019
Keywords
Coronavirus 2019, Cardiovascular System, Arterial Stiffness, Echocardiography, Cardiopulmonary exercise stress testing, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-COVID participants
Arm Type
No Intervention
Arm Title
COVID participants in intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
COVID participants assigned to usual daily activity
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Active-at-home-HF
Intervention Description
Increase daily step count by 2,000 and weekly telephone calls.
Primary Outcome Measure Information:
Title
Difference and change in left ventricular global longitudinal strain.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Secondary Outcome Measure Information:
Title
Difference and change in pulse wave velocity.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in augmentation index.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in resting cardiac output.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in maximal cardiac output.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in resting heart rate.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in maximal heart rate.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in resting stroke volume.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in maximal stroke volume.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in resting systemic vascular resistance.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in maximal systemic vascular resistance.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in maximal oxygen uptake (VO2 max).
Description
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).
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in Forced Expiratory Volume 1 (FEV1)/ forced vital capacity (FVC) ratio.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Change in quality of life measured by the SF-36 questionnaire between baseline and post intervention assessment at 12 weeks.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in depression, anxiety and stress measured on the DASS-21 questionnaire.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in global sleep efficiency.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Change in sleep efficiency.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in right ventricular global longitudinal strain.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in left atrial strain.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in ventricular arterial coupling.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in right ventricular diastolic function.
Description
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)).
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in electrocardiography (ECG) R-R interval average.
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in root mean square of successive ECG RR interval difference (RMSSD).
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in Standard Deviation Normal RR Intervals (SDNN).
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in low-frequency power (LF).
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in high-frequency power (HF).
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in low-frequency power (LFnu).
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)
Title
Difference and change in low-frequency power (HFnu).
Description
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.
Time Frame
12 weeks (baseline to 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Facility Information:
Facility Name
Coventry University
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV1 2DS
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Cardiovascular Function and Physical Activity in COVID-19

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