Clinical trial NCT05242211: Cardio-Pulmonary Exercise Testing in Healthy Population
Official title: Protocols Adjustments for Cardio-Pulmonary Exercise Testing in Healthy Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Obesity, Metabolically
Keywords: exercise
maximal exercise test
exercise protocol
metabolic
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2022-02-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy volunteers (normal and overweight ) will be recruited to participants in the study. Demographics (age, sex), anthropometric (height, weight, abdominal circumference), will be measured. By using questionnaire, physical activity behavior and motivation toward engage in physical activity will be filled by the participants. Each participants will conducted an exercise test on treadmill (using Modified Bruce Protocol) and cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be used 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.
Primary purpose: OTHER

Brief summary: Introduction: Cardiopulmonary exercise test (CPET) is a helpful tool for evaluation of aerobic exercise capacity and tolerance for variety of population. The test progression include an incremental stepwise or ramp control protocol to exhaustion There are different methods used in various clinical setting. CPET involves the 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 on a cycle-ergo meter or treadmill. This test allow to assess an integrative exercise responses to submaximal and maximal effort.

Aim: To compere exercise responses and achieved criteria for maximal exercise testing with different exercise protocol Methods: Healthy volunteers (normal and overweight ) will be recruited to participants in the study. Demographics (age, sex), anthropometric (height, weight, abdominal circumference), will be measured. By using questionnaire, physical activity behavior and motivation toward engage in physical activity will be filled by the participants. Each participants will conducted an exercise test on treadmill (using Modified Bruce Protocol) and cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be used 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 exercise parameter done on the different ergometer will be compared


Eligibility criteria: Inclusion Criteria:

* Healthy 18-55

Exclusion Criteria:

* Physical activity limitation due to orthopedic , neurological and cognition deficit Pregnancy children

Primary outcomes:
measure: VO2 MAX
timeFrame: through study completion, an average of 1 year
measure: RPE-rate of perceived exertion
timeFrame: through study completion, an average of 1 year
measure: Max heart rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
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:
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citation: Lafortuna CL, Lazzer S, Agosti F, Busti C, Galli R, Mazzilli G, Sartorio A. Metabolic responses to submaximal treadmill walking and cycle ergometer pedalling in obese adolescents. Scand J Med Sci Sports. 2010 Aug;20(4):630-7. doi: 10.1111/j.1600-0838.2009.00975.x. Epub 2009 Aug 23.
citation: Mezzani A. Cardiopulmonary Exercise Testing: Basics of Methodology and Measurements. Ann Am Thorac Soc. 2017 Jul;14(Supplement_1):S3-S11. doi: 10.1513/AnnalsATS.201612-997FR.
citation: Lollgen H, Leyk D. Exercise Testing in Sports Medicine. Dtsch Arztebl Int. 2018 Jun 15;115(24):409-416. doi: 10.3238/arztebl.2018.0409.