Clinical trial NCT05263687: Exercise Testing in Diseases and Health
Official title: Cardio Pulmonary Exercise Testing (CPET) in Diseases and Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Test
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2022-03-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 4
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximal Oxygen consumption
timeFrame: through study completion, an average of 1 year
measure: Maximal Heart rate
timeFrame: through study completion, an average of 1 year
measure: Maximal Blood pressure
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Ventilation Anaerobic Threshold
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Teverya
country: Israel
facility: The BARUCH PADEH Medical Center, Poriya
state: The Lower Galilee
Study officials:
affiliation: The Baruch Padeh Medical Center, Poriya
name: Gur Mainzer, MD
role: PRINCIPAL_INVESTIGATOR
References: