Validity and Reliability of a Clinical Method for Assessment of Cardiorespiratory Fitness Using Seismocardiography

NCT05356871 | Completed

• 1 other identifier: VentriJect Validation Study
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Measurement of cardiorespiratory fitness (here VO2max) is considered a valuable tool for improving the risk prediction of cardiovascular disease and overall patient management. However, the gold standard method for determining VO2max requires both maximal exercise until exhaustion and expensive equipment, why it is not always feasible. A new method for estimating VO2max using a non-exercise prediction model with seismocardiography (SCG) information has been proposed. SCG is recording and interpretations of vibrations originating from the beating heart measured on the chest wall with an accelerometer. SCG has previously been shown to correlate to physiologic events in the cardiac cycle and thus a measure of cardiac performance. VO2max is generally believed to be limited by the rate of oxygen delivery to the muscles, where maximal cardiac output and oxygen carrying capacity of the blood are considered the main limiting factors. The theoretical basis for incorporating SCG to a VO2max prediction model is therefore evident. The previous studies assessed the prediction model in a cross-sectional study design to compare validity of the method. A requirement of further validation of the prediction model with reliability assessment is therefore needed. Biological age is a concept trying to relate the age to the health status rather than the date of birth. Biological age assesses the heterogeneity in functional metabolic status and vulnerability to disease. A Biological age model has previously been designed for health promotion interventions. However, reliability assessment of the model is needed. The purpose of the current study was therefore to:

1. 1.investigate the validity and reliability of a new clinical method for estimation of maximal oxygen consumption (VO2max) using seismocardiography.
2. 2.investigate the reliability of the biological age model.

Conditions

Cardiorespiratory Fitness Test

Keywords

Validity; Reliability; VO2max testing; Biological age

Outcome Measures

Primary Outcomes (1)

• Validity and reliability of the SCG VO2max prediction model

  For assessment of validity and reliability of the SCG VO2max prediction model, three repeated measures of SCG VO2max and the gold standard determination of VO2max will be conducted on three different test days within 14 days. The validity assessment will be based on differences and agreement between the two methods. The reliability assessment will be based on intra-method variations between test days.

  From June until December

Secondary Outcomes (1)

• Reliability of the biological age model

  From June until December

Study Arms (1)

Healthy participants

Healthy men and women within the age of 18 and 75 yrs.

Other: VO2max validity and reliability assesment

Interventions

VO2max validity and reliability assesment OTHER

Reliability assessment of VO2max determination with three repeated measures for two methods.

Healthy participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A representative selection of the healthy adult population

You may qualify if:

• Healthy participants

You may not qualify if:

• A history of previous or current cardiovascular disease
• Pregnancy
• Conditions that prevent maximal cycling exercise

Sponsors & Collaborators

• University of Copenhagen: lead
• VentriJect ApS: collaborator

Study Sites (1)

Xlab, Faculty of Health and Medical Sciences, University of Copenhagen

Copenhagen, 2200, Denmark

Location

Related Publications (4)

• Sorensen K, Schmidt SE, Jensen AS, Sogaard P, Struijk JJ. Definition of Fiducial Points in the Normal Seismocardiogram. Sci Rep. 2018 Oct 18;8(1):15455. doi: 10.1038/s41598-018-33675-6.

  PMID: 30337579 BACKGROUND

• Sorensen K, Poulsen MK, Karbing DS, Sogaard P, Struijk JJ, Schmidt SE. A Clinical Method for Estimation of VO2max Using Seismocardiography. Int J Sports Med. 2020 Sep;41(10):661-668. doi: 10.1055/a-1144-3369. Epub 2020 May 26.

  PMID: 32455456 BACKGROUND

• Hansen MT, Grønfeldt BM, Rømer T, Fogelstrøm M, Sørensen K, Schmidt SE, et al. Determination of Maximal Oxygen Uptake Using Seismocardiography at Rest. In: Computing in Cardiology 2021. IEEE. 2021;48(1):48-51 DOI: 10.22489/CinC.2021.165

  BACKGROUND

• Husted KLS, Fogelstrom M, Hulst P, Brink-Kjaer A, Henneberg KA, Sorensen HBD, Dela F, Helge JW. A Biological Age Model Designed for Health Promotion Interventions: Protocol for an Interdisciplinary Study for Model Development. JMIR Res Protoc. 2020 Oct 26;9(10):e19209. doi: 10.2196/19209.

  PMID: 33104001 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

Study Officials

• Jørn W Helge, Professor

  Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: June 29, 2020
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)