NCT05492552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

August 3, 2022

Last Update Submit

August 30, 2023

Conditions

Coronavirus 2019

Keywords

Coronavirus 2019Cardiovascular SystemArterial StiffnessEchocardiographyCardiopulmonary exercise stress testingCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Difference and change in left ventricular global longitudinal strain.

    1. Difference in left ventricular global longitudinal strain between COVID and non-COVID participants at rest and during peak exercise on baseline assessment. 2. 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.

    12 weeks (baseline to 12 weeks)

Secondary Outcomes (27)

  • Difference and change in pulse wave velocity.

    12 weeks (baseline to 12 weeks)

  • Difference and change in augmentation index.

    12 weeks (baseline to 12 weeks)

  • Difference and change in resting cardiac output.

    12 weeks (baseline to 12 weeks)

  • Difference and change in maximal cardiac output.

    12 weeks (baseline to 12 weeks)

  • Difference and change in resting heart rate.

    12 weeks (baseline to 12 weeks)

  • +22 more secondary outcomes

Study Arms (3)

Non-COVID participants

NO INTERVENTION

COVID participants in intervention

EXPERIMENTAL

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.

Behavioral: Active-at-home-HF

COVID participants assigned to usual daily activity

NO INTERVENTION

Interventions

Active-at-home-HFBEHAVIORAL

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

COVID participants in intervention

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coventry University

Coventry, West Midlands, CV1 2DS, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 37179415DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 8, 2022

Study Start

April 7, 2022

Primary Completion

May 11, 2023

Study Completion

May 11, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations

GB(1)