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Completed

NCT Number: NCT04929431

Validation of an Algorithm to Predict the Ventilatory Threshold

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No present CVD

Treatment and study plan

Primary outcomes

  1. Duration during cardiopulmonary exercise testing

    Time frame: Baseline - day 1

    Test duration (min)

  2. Workload during cardiopulmonary exercise testing

    Time frame: Baseline - day 1

    Peak workload (watt)

  3. Heart rate during cardiopulmonary exercise testing

    Time frame: Baseline - day 1

    Peak heart rate (bpm)

  4. Oxygen uptake during cardiopulmonary exercise testing

    Time frame: Baseline - day 1

    Maximal oxygen uptake (ml/kg/min)

  5. Heart rate in rest during cardiopulmonary exercise testing

    Time frame: Baseline - day 1

    Resting heart rate (bpm)

Secondary outcomes

  1. Hypertension (in mmHg)

    Time frame: Baseline

    Blood pressure measurement with a automatic blood pressure cuff.

  2. Dyslipdemia (in mg/dl)

    Time frame: Baseline

    Blood lipid concentration in mg/dl

  3. Diabetes (mg/dl)

    Time frame: Baseline

    Glucose concentration in the blood in mg/dl

  4. Obesity

    Time frame: Baseline

    Presence of obesity determined by the BMI (see below)

  5. Smoking

    Time frame: Baseline

    Presence of smoking by questionnaire (yes/no)

  6. Medication intake

    Time frame: Baseline

    Information regarding medication intake will be retrospectively extracted by personal communication with the subject

  7. Cardiovascular surgery

    Time frame: Baseline

    Information regarding cardiovascular surgery will be extracted by personal communication with the subject

  8. Age in years

    Time frame: Baseline

    Age in years will be retrospectively extracted from the databank

  9. Gender (m/f)

    Time frame: Baseline

    Gender in m/f will be retrospectively extracted from the databank

  10. Length in meters

    Time frame: Baseline

    Length in meter will be retrospectively extracted from the databank

  11. Weight in kg

    Time frame: Baseline

    Weight in kg will be retrospectively extracted from the databank

  12. BMI (kg/m^2)

    Time frame: Baseline

    Weight (in kg) and height (in m) will be combined to assess BMI (in kg/m^2)

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Technical University of Munich
  • Universitaire Ziekenhuizen KU Leuven
  • University of Bern
  • University of Brasilia
  • University of Siena

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2021
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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