Validation of an Algorithm to Predict the Ventilatory Threshold

NCT ID: NCT04929431

Last Updated: 2021-06-18

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

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-04-01

Brief Summary

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The aim of the current study was to develop an algorithm which has the ability to accurately predict the first and second ventilatory threshold and in cardiovascular disease patients and to guide in proper exercise intensity determination. This would then help, at least in part, to overcome the lack of access to metabolic carts or cardiopulmonary exercise test, and/or methodological difficulties with ventilatory threshold determination in these patients.

Detailed Description

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Design

This study is composed out of two sub studies: 1. Generation/creation of VT prediction algorithm, and 2. Validation of this algorithm in independent laboratories.

Sub study 1: Generation/creation of VT prediction algorithm

From April 2015 up to July 2020, data from CVD (risk) patients (e.g. obesity, diabetes, coronary artery disease or heart failure) were collected from in light of research studies. All participants signed an informed consent explaining the nature and risks of CPET, and allowing us to use anonymized data for the analyses of their CPET at entry of cardiovascular rehabilitation or an exercise intervention. These data have been published in previous publications.

Sub study 2: Validation of the algorithm in independent laboratories

From April 2015 up to July 2020, data from CVD (risk) patients (e.g. obesity, diabetes, coronary artery disease or heart failure) were collected in light of research studies. All participants signed an informed consent (approved by the ethics committees of the local hospitals or research laboratories) explaining the nature and risks of CPET, and allowing us to use anonymized data for the analyses of their CPET at entry of CR or an exercise intervention. These data have been published in previous publications

Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* CVD patients (eg obesity, diabetes, coronary heart disease, heart failure)

Exclusion Criteria

* No present CVD
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Brasilia

OTHER

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

University of Siena

OTHER

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Dominique Hansen

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dominique Hansen, Prof.dr

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

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Hasselt University

Diepenbeek, Limburg, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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VT algorithm validation

Identifier Type: -

Identifier Source: org_study_id

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