Clinical trial NCT04929431: Validation of an Algorithm to Predict the Ventilatory Threshold
Official title: Validation of an Algorithm to Predict the Ventilatory Threshold for Exercise Intensity Prescription in Patients With Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: University of Brasilia
name: University of Bern
name: Universitaire Ziekenhuizen KU Leuven
name: University of Siena
name: Technical University of Munich
First posted: 2021-06-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 Jessa hospital, Hasselt, Belgium, and Hasselt university, Faculty of Rehabilitation Sciences, Hasselt, Belgium, in light of research studies. All participants signed an informed consent (approved by the ethical committees of Jessa hospital Hasselt and/or Hasselt University) 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

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No present CVD

Primary outcomes:
measure: Duration during cardiopulmonary exercise testing
timeFrame: Baseline - day 1
measure: Workload during cardiopulmonary exercise testing
timeFrame: Baseline - day 1
measure: Heart rate during cardiopulmonary exercise testing
timeFrame: Baseline - day 1
measure: Oxygen uptake during cardiopulmonary exercise testing
timeFrame: Baseline - day 1
measure: Heart rate in rest during cardiopulmonary exercise testing
timeFrame: Baseline - day 1
Secondary outcomes:
measure: Hypertension (in mmHg)
timeFrame: Baseline
measure: Dyslipdemia (in mg/dl)
timeFrame: Baseline
measure: Diabetes (mg/dl)
timeFrame: Baseline
measure: Obesity
timeFrame: Baseline
measure: Smoking
timeFrame: Baseline
measure: Medication intake
timeFrame: Baseline
measure: Cardiovascular surgery
timeFrame: Baseline
measure: Age in years
timeFrame: Baseline
measure: Gender (m/f)
timeFrame: Baseline
measure: Length in meters
timeFrame: Baseline
measure: Weight in kg
timeFrame: Baseline
measure: BMI (kg/m^2)
timeFrame: Baseline
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: Hasselt University
name: Dominique Hansen, Prof.dr
role: PRINCIPAL_INVESTIGATOR
References: