Validation of an Algorithm to Predict the Ventilatory Thr... | NCT04929431

Studies
Validation of an Algorithm to Predict the Ventilatory Threshold

NCT04929431

Sponsor

Hasselt University

Status

Completed

Last Update Posted

Jun 18, 2021Actual

Enrollment

3,000Actual

Phase

Not provided

Conditions

Cardiovascular Diseases

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Mar 30, 2021Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

May 18, 2021

First Submission Date that Met QC Criteria

Jun 10, 2021

First Posted Date

Jun 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2021

Last Update Posted Date

Jun 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dominique Hansen, Prof. Dr., Hasselt UniversityPrincipal Investigator

Lead Sponsor

Hasselt UniversityOTHER

Collaborators

Name	Class
University of Brasilia	OTHER
University of Bern	OTHER
Universitaire Ziekenhuizen KU Leuven	OTHER
University of Siena

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No present CVD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dominique Hansen, Prof.dr	Hasselt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hasselt University		Diepenbeek	Limburg	3590	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided