Validation of an Algorithm to Predict the Ventilatory Threshold

Cardiovascular Diseases Clinical Trial

Official title:

Validation of an Algorithm to Predict the Ventilatory Threshold for Exercise Intensity Prescription in Patients With Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929431
• Other study ID #: VT algorithm validation
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: April 1, 2021

Study information

• Verified date: June 2021
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: April 1, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No present CVD

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
Belgium	Hasselt University	Diepenbeek	Limburg

Sponsors (6)

Lead Sponsor	Collaborator
Hasselt University	Leuven University, Technische Universität München, University of Bern, University of Brasilia, University of Siena

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration during cardiopulmonary exercise testing	Test duration (min)	Baseline - day 1
Primary	Workload during cardiopulmonary exercise testing	Peak workload (watt)	Baseline - day 1
Primary	Heart rate during cardiopulmonary exercise testing	Peak heart rate (bpm)	Baseline - day 1
Primary	Oxygen uptake during cardiopulmonary exercise testing	Maximal oxygen uptake (ml/kg/min)	Baseline - day 1
Primary	Heart rate in rest during cardiopulmonary exercise testing	Resting heart rate (bpm)	Baseline - day 1
Secondary	Hypertension (in mmHg)	Blood pressure measurement with a automatic blood pressure cuff.	Baseline
Secondary	Dyslipdemia (in mg/dl)	Blood lipid concentration in mg/dl	Baseline
Secondary	Diabetes (mg/dl)	Glucose concentration in the blood in mg/dl	Baseline
Secondary	Obesity	Presence of obesity determined by the BMI (see below)	Baseline
Secondary	Smoking	Presence of smoking by questionnaire (yes/no)	Baseline
Secondary	Medication intake	Information regarding medication intake will be retrospectively extracted by personal communication with the subject	Baseline
Secondary	Cardiovascular surgery	Information regarding cardiovascular surgery will be extracted by personal communication with the subject	Baseline
Secondary	Age in years	Age in years will be retrospectively extracted from the databank	Baseline
Secondary	Gender (m/f)	Gender in m/f will be retrospectively extracted from the databank	Baseline
Secondary	Length in meters	Length in meter will be retrospectively extracted from the databank	Baseline
Secondary	Weight in kg	Weight in kg will be retrospectively extracted from the databank	Baseline
Secondary	BMI (kg/m^2)	Weight (in kg) and height (in m) will be combined to assess BMI (in kg/m^2)	Baseline