Exercise Testing in Diseases and Health

Not Applicable

Recruiting

• Conditions: Exercise Test
• Interventions: Diagnostic Test: Maximal exercise test

• Registration Number: NCT05263687
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

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.

Study Timeline

• Study Start: 2017-08-30
• Study First Submitted: 2022-02-13
• Study First Submitted QC: 2022-02-27
• Status Verified: 2022-03
• Study First Posted: 2022-03-02
• Last Update Submitted: 2022-03-06
• Last Update Posted: 2022-03-21
• Primary Completion: 2025-03-19
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise Test	Maximal exercise test	maximal and anaerobic threshold cardiopulmonary parameters

Primary Outcome Measures

Name	Time	Method
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 Blood pressure	through study completion, an average of 1 year	the blood pressure in the end of 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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The BARUCH PADEH Medical Center, Poriya; 🇮🇱 Teverya, The Lower Galilee, Israel