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

Coventry University

Status: Completed

Conditions: Coronavirus 2019

Treatments: Behavioral: Active-at-home-HF

Study type: Interventional

Funder types: Other

Identifiers

NCT05492552

P125303

Details and patient eligibility

About

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.

Full 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).

Enrollment: 124 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 3 patient groups

Non-COVID participants

No Intervention group

COVID participants in intervention

Experimental group

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.

Treatment:

Behavioral: Active-at-home-HF

COVID participants assigned to usual daily activity

No Intervention group