Exercise Testing in Diseases and Health

Sponsor

The Baruch Padeh Medical Center, Poriya (Other)

Overall Status

Recruiting

CT.gov ID

NCT05263687

Collaborator

(none)

1,000

Enrollment

Location

Arm

100

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cardiopulmonary exercise test (CPET) is a helpful tool for evaluation of aerobic exercise capacity and tolerance for variety of population. CPET provides a full assessment of the physiologic responses of the pulmonary, cardiovascular, muscular, and cellular oxidative systems to exercise. The test progression include a incremental stepwise (on treadmill) or ramp control protocol (on bike ergometer ) to exhaustion. Measurement of respiratory gas exchange i.e. oxygen uptake, carbon dioxide, minute ventilation, other variables while monitoring ECG, blood pressure, pulse oximetry and exertion perceived (Borg Scale) during an incremental test .

Aim: To compere exercise responses for maximal exercise testing with different population.

Condition or Disease	Intervention/Treatment	Phase
Exercise Test	Diagnostic Test: Maximal exercise test	N/A

Detailed Description

Each participants will conducted an exercise test on treadmill using Modified Bruce Protocol) or cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be use to collect and analysis gas exchange. 10 minute after the graded exercise test Supra maximal exercise test (SMT) will be done for 2 minutes one stage (treadmill protocol) or 10% at cycle protocol higher than highest load achieved in the incremental test.

all outcome measurement will be collected. Exercise tolerance and responses will be assess using the data of : pulmonary gas exchange; cardiovascular performance, and skeletal muscle metabolism.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Cardio Pulmonary Exercise Testing (CPET) in Diseases and Health

Actual Study Start Date :

Aug 30, 2017

Anticipated Primary Completion Date :

Mar 19, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise Test maximal and anaerobic threshold cardiopulmonary parameters	Diagnostic Test: Maximal exercise test Each participants will conduct a spirometry test and exercise test on treadmill (using Modified Bruce Protocol) or cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be used to collect and analysis gas exchange, ECG, gas volume in addition rating of perceived exertion will be asked.

Arm

Intervention/Treatment

Experimental: Exercise Test

maximal and anaerobic threshold cardiopulmonary parameters

Diagnostic Test: Maximal exercise test

Each participants will conduct a spirometry test and exercise test on treadmill (using Modified Bruce Protocol) or cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be used to collect and analysis gas exchange, ECG, gas volume in addition rating of perceived exertion will be asked.

Outcome Measures

Primary Outcome Measures

Maximal Oxygen consumption [through study completion, an average of 1 year]
the maximum amount of oxygen that an individual can utilize during intense or maximal exercise.
Maximal Heart rate [through study completion, an average of 1 year]
the maximum heart rate achieved during intense or maximal exercise.
Maximal Blood pressure [through study completion, an average of 1 year]
the blood pressure in the end of intense or maximal exercise.

Secondary Outcome Measures

Ventilation Anaerobic Threshold [through study completion, an average of 1 year]
Ventilatory Threshold (VT) describes the inflection point for ventilation during an incremental exercise test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

*Patient who invited to the clinic to do incremental maximal exercise test or healthy *Participants with no known significant health problems.

Exclusion Criteria:

Acute fever
Acute myocardial infarction within 2 to 3 days.
Unstable angina not previously stabilized by medical therapy.
Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise.
Symptomatic severe aortic stenosis.
Uncontrolled symptomatic heart failure.
Inability to perform exercise Orthopedic impairment severely compromising exercise performance.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The BARUCH PADEH Medical Center, Poriya	Teverya	The Lower Galilee	Israel	15208

Sponsors and Collaborators

The Baruch Padeh Medical Center, Poriya

Investigators

Principal Investigator: Gur Mainzer, MD, The Baruch Padeh Medical Center, Poriya

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gur Mainzer, Head of the pediatric cardiology department, The Baruch Padeh Medical Center, Poriya

ClinicalTrials.gov Identifier:

NCT05263687

Other Study ID Numbers:

0033-17-POR

First Posted:

Mar 2, 2022

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 21, 2022