Exercise Testing in Diseases and Health

NCT05263687 | Unknown DMC

• 1 other identifier: 0033-17-POR
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Test

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Ventilation Anaerobic Threshold

  through study completion, an average of 1 year

Study Arms (1)

Exercise Test

EXPERIMENTAL

maximal and anaerobic threshold cardiopulmonary parameters

Diagnostic Test: Maximal exercise test

Interventions

Maximal exercise test DIAGNOSTIC_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.

Exercise Test

Eligibility Criteria

• Age: 4 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Baruch Padeh Medical Center, Poriya: lead

Study Sites (1)

The BARUCH PADEH Medical Center, Poriya

Tiberias, The Lower Galilee, 15208, Israel

RECRUITING

Study Officials

• Gur Mainzer, MD

  The Baruch Padeh Medical Center, Poriya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gur Mainzer, MD

CONTACT

+972543078940; GMainzer@poria.health.gov.il

Einat Kodesh, PhD

CONTACT

+972523489854; Ekodesh@poria.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the pediatric cardiology department

Study Record Dates

• First Submitted: February 13, 2022
• First Posted: March 2, 2022
• Study Start: August 30, 2017
• Primary Completion: March 19, 2025
• Study Completion: December 30, 2025
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)