Exercise Testing in Diseases and Health

Exercise Test Clinical Trial

Official title:

Cardio Pulmonary Exercise Testing (CPET) in Diseases and Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05263687
• Other study ID #: 0033-17-POR
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2017
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2022
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: Gur Mainzer, MD
• Phone: +972543078940
• Email: GMainzer[@]poria.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2025
• Est. primary completion date: March 19, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise Test

Intervention

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.

Locations

Country	Name	City	State
Israel	The BARUCH PADEH Medical Center, Poriya	Teverya	The Lower Galilee

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Oxygen consumption	the maximum amount of oxygen that an individual can utilize during intense or maximal exercise.	through study completion, an average of 1 year
Primary	Maximal Heart rate	the maximum heart rate achieved during intense or maximal exercise.	through study completion, an average of 1 year
Primary	Maximal Blood pressure	the blood pressure in the end of intense or maximal exercise.	through study completion, an average of 1 year
Secondary	Ventilation Anaerobic Threshold	Ventilatory Threshold (VT) describes the inflection point for ventilation during an incremental exercise test.	through study completion, an average of 1 year