Exercise Testing in Diseases and Health

Cardio Pulmonary Exercise Testing (CPET) in Diseases and Health

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise Test
• Intervention / Treatment: Diagnostic test: Maximal exercise test

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 Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gur Mainzer, MD; Phone Number: +972543078940; Email: GMainzer@poria.health.gov.il
• Study Contact Backup: Name: Einat Kodesh, PhD; Phone Number: +972523489854; Email: Ekodesh@poria.health.gov.il

Study Locations

• Israel
  • The Lower Galilee
    • Teverya, The Lower Galilee, Israel, 15208
      • Recruiting
      • The Baruch Padeh Medical Center, Poriya
      • Contact: Odelia Katz; Email: okatz@poria.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Maximal Heart rate	the maximum heart rate achieved during intense or maximal exercise.	through study completion, an average of 1 year
Maximal Blood pressure	the blood pressure in the end of intense or maximal exercise.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2017
• Primary Completion (ANTICIPATED): March 19, 2025
• Study Completion (ANTICIPATED): December 30, 2025

Study Registration Dates

• First Submitted: February 13, 2022
• First Submitted That Met QC Criteria: February 27, 2022
• First Posted (ACTUAL): March 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 0033-17-POR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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