Cardiovascular Function and Physical Activity in COVID-19

NCT ID: NCT05492552

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2023-05-11

Brief Summary

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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

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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).

Conditions

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Coronavirus 2019

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-COVID participants

Group Type NO_INTERVENTION

No interventions assigned to this group

COVID participants in intervention

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.

Group Type EXPERIMENTAL

Active-at-home-HF

Intervention Type BEHAVIORAL

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

COVID participants assigned to usual daily activity

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active-at-home-HF

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Coventry University

OTHER

Sponsor Role lead

Responsible Party

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Djordje Jakovljevic

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Coventry University

Coventry, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37179415 (View on PubMed)

Other Identifiers

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P125303

Identifier Type: -

Identifier Source: org_study_id

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