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

Abstract Background The clinical manifestation of COVID-19 is associated with infection and inflammation of the lungs, but there is evidence to suggest that COVID-19 may also affect the structure and function of the cardiovascular system. At present, it is not fully understood to what extent COVID-1...

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Main Authors: Mushidur Rahman, Sophie L. Russell, Nduka C. Okwose, Olivia M. A. Hood, Amy E. Harwood, Gordon McGregor, Stuart M. Raleigh, Hardip Sandhu, Laura C. Roden, Helen Maddock, Prithwish Banerjee, Djordje G. Jakovljevic
Format: Article
Language:English
Published: BMC 2023-05-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-023-07360-7
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author Mushidur Rahman
Sophie L. Russell
Nduka C. Okwose
Olivia M. A. Hood
Amy E. Harwood
Gordon McGregor
Stuart M. Raleigh
Hardip Sandhu
Laura C. Roden
Helen Maddock
Prithwish Banerjee
Djordje G. Jakovljevic
author_facet Mushidur Rahman
Sophie L. Russell
Nduka C. Okwose
Olivia M. A. Hood
Amy E. Harwood
Gordon McGregor
Stuart M. Raleigh
Hardip Sandhu
Laura C. Roden
Helen Maddock
Prithwish Banerjee
Djordje G. Jakovljevic
author_sort Mushidur Rahman
collection DOAJ
description Abstract Background The clinical manifestation of COVID-19 is associated with infection and inflammation of the lungs, but there is evidence to suggest that COVID-19 may also affect the structure and function of the cardiovascular system. At present, it is not fully understood to what extent COVID-19 impacts cardiovascular function in the short- and long-term following infection. The aim of the present study is twofold: (i) to define the effect of COVID-19 on cardiovascular function (i.e. arterial stiffness, cardiac systolic and diastolic function) in otherwise healthy individuals and (ii) to evaluate the effect of a home-based physical activity intervention on cardiovascular function in people with a history of COVID-19. Methods This prospective, single-centre, observational study will recruit 120 COVID-19-vaccinated adult participants aged between 50 and 85 years, i.e. 80 with a history of COVID-19 and 40 healthy controls without a history of COVID-19. All participants will undergo baseline assessments including 12-lead electrocardiography, heart rate variability, arterial stiffness, rest and stress echocardiography with speckle tracking imaging, spirometry, maximal cardiopulmonary exercise testing, 7-day physical activity and sleep measures and quality of life questionnaires. Blood samples will be collected to assess the microRNA expression profiles, cardiac and inflammatory biomarkers, i.e. cardiac troponin T; N-terminal pro B-type natriuretic peptide; tumour necrosis factor alpha; interleukins 1, 6 and 10; C-reactive protein; d-dimer; and vascular endothelial growth factors. Following baseline assessments, COVID-19 participants will be randomised 1:1 into a 12-week home-based physical activity intervention aiming to increase their daily number of steps by 2000 from baseline. The primary outcome is change in left ventricular global longitudinal strain. Secondary outcomes are arterial stiffness, systolic and diastolic function of the heart, functional capacity, lung function, sleep measures, quality of life and well-being (depression, anxiety, stress and sleep efficiency). Discussion The study will provide insights into the cardiovascular implications of COVID-19 and their malleability with a home-based physical activity intervention. Trial registration ClinicalTrials.gov NCT05492552. Registered on 7 April 2022.
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spelling doaj.art-071c874985204d76b68cd646914a88f72023-05-14T11:26:49ZengBMCTrials1745-62152023-05-012411910.1186/s13063-023-07360-7Cardiovascular implications and physical activity in middle-aged and older adults with a history of COVID-19 (CV COVID): a protocol for a randomised controlled trialMushidur Rahman0Sophie L. Russell1Nduka C. Okwose2Olivia M. A. Hood3Amy E. Harwood4Gordon McGregor5Stuart M. Raleigh6Hardip Sandhu7Laura C. Roden8Helen Maddock9Prithwish Banerjee10Djordje G. Jakovljevic11Research Centre for Health and Life Sciences, Institute for Health and Wellbeing, Faculty of Health and Life Sciences, Coventry UniversityResearch Centre for Health and Life Sciences, Institute for Health and Wellbeing, Faculty of Health and Life Sciences, Coventry UniversityResearch Centre for Health and Life Sciences, Institute for Health and Wellbeing, Faculty of Health and Life Sciences, Coventry UniversitySchool of Biosciences, College of Biomedical and Life Sciences, Cardiff UniversityResearch Centre for Health and Life Sciences, Institute for Health and Wellbeing, Faculty of Health and Life Sciences, Coventry UniversityResearch Centre for Health and Life Sciences, Institute for Health and Wellbeing, Faculty of Health and Life Sciences, Coventry UniversityResearch Centre for Health and Life Sciences, Institute for Health and Wellbeing, Faculty of Health and Life Sciences, Coventry UniversityResearch Centre for Health and Life Sciences, Institute for Health and Wellbeing, Faculty of Health and Life Sciences, Coventry UniversityResearch Centre for Health and Life Sciences, Institute for Health and Wellbeing, Faculty of Health and Life Sciences, Coventry UniversityResearch Centre for Health and Life Sciences, Institute for Health and Wellbeing, Faculty of Health and Life Sciences, Coventry UniversityResearch Centre for Health and Life Sciences, Institute for Health and Wellbeing, Faculty of Health and Life Sciences, Coventry UniversityResearch Centre for Health and Life Sciences, Institute for Health and Wellbeing, Faculty of Health and Life Sciences, Coventry UniversityAbstract Background The clinical manifestation of COVID-19 is associated with infection and inflammation of the lungs, but there is evidence to suggest that COVID-19 may also affect the structure and function of the cardiovascular system. At present, it is not fully understood to what extent COVID-19 impacts cardiovascular function in the short- and long-term following infection. The aim of the present study is twofold: (i) to define the effect of COVID-19 on cardiovascular function (i.e. arterial stiffness, cardiac systolic and diastolic function) in otherwise healthy individuals and (ii) to evaluate the effect of a home-based physical activity intervention on cardiovascular function in people with a history of COVID-19. Methods This prospective, single-centre, observational study will recruit 120 COVID-19-vaccinated adult participants aged between 50 and 85 years, i.e. 80 with a history of COVID-19 and 40 healthy controls without a history of COVID-19. All participants will undergo baseline assessments including 12-lead electrocardiography, heart rate variability, arterial stiffness, rest and stress echocardiography with speckle tracking imaging, spirometry, maximal cardiopulmonary exercise testing, 7-day physical activity and sleep measures and quality of life questionnaires. Blood samples will be collected to assess the microRNA expression profiles, cardiac and inflammatory biomarkers, i.e. cardiac troponin T; N-terminal pro B-type natriuretic peptide; tumour necrosis factor alpha; interleukins 1, 6 and 10; C-reactive protein; d-dimer; and vascular endothelial growth factors. Following baseline assessments, COVID-19 participants will be randomised 1:1 into a 12-week home-based physical activity intervention aiming to increase their daily number of steps by 2000 from baseline. The primary outcome is change in left ventricular global longitudinal strain. Secondary outcomes are arterial stiffness, systolic and diastolic function of the heart, functional capacity, lung function, sleep measures, quality of life and well-being (depression, anxiety, stress and sleep efficiency). Discussion The study will provide insights into the cardiovascular implications of COVID-19 and their malleability with a home-based physical activity intervention. Trial registration ClinicalTrials.gov NCT05492552. Registered on 7 April 2022.https://doi.org/10.1186/s13063-023-07360-7COVID-19CoronavirusCardiovascular systemRandomised controlled trialEchocardiographyArterial stiffness
spellingShingle Mushidur Rahman
Sophie L. Russell
Nduka C. Okwose
Olivia M. A. Hood
Amy E. Harwood
Gordon McGregor
Stuart M. Raleigh
Hardip Sandhu
Laura C. Roden
Helen Maddock
Prithwish Banerjee
Djordje G. Jakovljevic
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
COVID-19
Coronavirus
Cardiovascular system
Randomised controlled trial
Echocardiography
Arterial stiffness
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic COVID-19
Coronavirus
Cardiovascular system
Randomised controlled trial
Echocardiography
Arterial stiffness
url https://doi.org/10.1186/s13063-023-07360-7
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