Clinical Trials Directory

Trials / Completed

CompletedNCT05505344

Estimating Peak Oxygen Uptake in People Living With Coronary Heart Disease

Exploring the Validity of Seismofit® for Estimating Peak Oxygen Uptake in People With Coronary Heart Disease

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
Sponsor
Sheffield Hallam University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

In people living with coronary heart disease (CHD), V̇O2 peak predicts all-cause mortality. V̇O2 peak increases with regular exercise training. Thus, in exercise-based cardiovascular rehabilitation programmes, V̇O2 peak is a useful marker of how effective the exercise training has been. Maximal cardiopulmonary exercise testing (CPET) is the gold standard method of measuring V̇O2 peak. However, maximal CPET is expensive and requires trained staff to conduct the test and interpret the results. Furthermore, CPET is not routinely available in United Kingdom (UK) cardiovascular rehabilitation programmes. Field exercise tests, such as incremental cycle ergometer tests, are used in conjunction with predictive equations to estimate V̇O2 peak. However, this group has shown that estimating changes in V̇O2 peak in this way is inaccurate. Alternative solutions are required. VentriJect Seismofit® uses a technique called seismocardiography (SCG); the measurement of vibrations in the chest wall, caused by each heartbeat, using accelerometers. SCG can be used to estimate V̇O2 peak from a SCG measurement taken at rest. This study will explore the validity of VentriJect Seismofit for estimating V̇O2 peak in people with CHD.

Conditions

Interventions

TypeNameDescription
DEVICEVentriJect Seismofit validationAll participants will have a resting and exercising electrocardiogram (ECG) trace and a lung function test, called spirometry, will be performed. They will take part in a maximal CPET to determine V̇O2 peak. Participants will also have their V̇O2 peak estimated twice, twenty minutes apart, using the VentriJect Seismofit device. A short questionnaire will be administered to explore the acceptability of completing a maximal CPET and having V̇O2 peak estimated using VentriJect Seismofit.

Timeline

Start date
2022-08-26
Primary completion
2023-02-20
Completion
2023-02-20
First posted
2022-08-17
Last updated
2023-12-01

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05505344. Inclusion in this directory is not an endorsement.