Clinical trial NCT05492552: Cardiovascular Function and Physical Activity in COVID-19
Official title: Cardiovascular Implications and Physical Activity in Middle-age and Older People With a History of Coronavirus 2019 (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus 2019
Keywords: Coronavirus 2019
Cardiovascular System
Arterial Stiffness
Echocardiography
Cardiopulmonary exercise stress testing
COVID-19
Lead sponsor: Coventry University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 124
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Difference and change in left ventricular global longitudinal strain.
timeFrame: 12 weeks (baseline to 12 weeks)
Secondary outcomes:
measure: Difference and change in pulse wave velocity.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in augmentation index.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in resting cardiac output.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in maximal cardiac output.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in resting heart rate.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in maximal heart rate.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in resting stroke volume.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in maximal stroke volume.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in resting systemic vascular resistance.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in maximal systemic vascular resistance.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in maximal oxygen uptake (VO2 max).
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in Forced Expiratory Volume 1 (FEV1)/ forced vital capacity (FVC) ratio.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Change in quality of life measured by the SF-36 questionnaire between baseline and post intervention assessment at 12 weeks.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in depression, anxiety and stress measured on the DASS-21 questionnaire.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in global sleep efficiency.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Change in sleep efficiency.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in right ventricular global longitudinal strain.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in left atrial strain.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in ventricular arterial coupling.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in right ventricular diastolic function.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in electrocardiography (ECG) R-R interval average.
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in root mean square of successive ECG RR interval difference (RMSSD).
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in Standard Deviation Normal RR Intervals (SDNN).
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in low-frequency power (LF).
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in high-frequency power (HF).
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in low-frequency power (LFnu).
timeFrame: 12 weeks (baseline to 12 weeks)
measure: Difference and change in low-frequency power (HFnu).
timeFrame: 12 weeks (baseline to 12 weeks)
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: Coventry University
state: West Midlands
Study officials:
References: