Validation of an Algorithm to Predict the Ventilatory Threshold

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases

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

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Diepenbeek, Limburg, Belgium, 3590
      • Hasselt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No present CVD

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration during cardiopulmonary exercise testing	Test duration (min)	Baseline - day 1
Workload during cardiopulmonary exercise testing	Peak workload (watt)	Baseline - day 1
Heart rate during cardiopulmonary exercise testing	Peak heart rate (bpm)	Baseline - day 1
Oxygen uptake during cardiopulmonary exercise testing	Maximal oxygen uptake (ml/kg/min)	Baseline - day 1
Heart rate in rest during cardiopulmonary exercise testing	Resting heart rate (bpm)	Baseline - day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypertension (in mmHg)	Blood pressure measurement with a automatic blood pressure cuff.	Baseline
Dyslipdemia (in mg/dl)	Blood lipid concentration in mg/dl	Baseline
Diabetes (mg/dl)	Glucose concentration in the blood in mg/dl	Baseline
Obesity	Presence of obesity determined by the BMI (see below)	Baseline
Smoking	Presence of smoking by questionnaire (yes/no)	Baseline
Medication intake	Information regarding medication intake will be retrospectively extracted by personal communication with the subject	Baseline
Cardiovascular surgery	Information regarding cardiovascular surgery will be extracted by personal communication with the subject	Baseline
Age in years	Age in years will be retrospectively extracted from the databank	Baseline
Gender (m/f)	Gender in m/f will be retrospectively extracted from the databank	Baseline
Length in meters	Length in meter will be retrospectively extracted from the databank	Baseline
Weight in kg	Weight in kg will be retrospectively extracted from the databank	Baseline
BMI (kg/m^2)	Weight (in kg) and height (in m) will be combined to assess BMI (in kg/m^2)	Baseline

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Universitaire Ziekenhuizen KU Leuven; University of Brasilia; University of Bern; Technical University of Munich; University of Siena
• Investigators: Principal Investigator: Dominique Hansen, Prof.dr, Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: VT algorithm validation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No