Cardio-Pulmonary Exercise Testing in Healthy Population

Healthy Obesity, Metabolically Clinical Trial

Official title:

Protocols Adjustments for Cardio-Pulmonary Exercise Testing in Healthy Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05242211
• Other study ID #: 0020-17-POR
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2022
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: Gur Mainzer, MD
• Phone: +972543078940
• Email: GMainzer[@]poria.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy 18-55

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Healthy Obesity, Metabolically
• Obesity, Metabolically Benign

Intervention

Other:
• exercise test
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.

Locations

Country	Name	City	State
Israel	The BARUCH PADEH Medical Center, Poriya	Teverya	The Lower Galilee

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Country where clinical trial is conducted

Israel, 

References & Publications (9)

Astorino TA, White AC, Dalleck LC. Supramaximal testing to confirm attainment of VO2max in sedentary men and women. Int J Sports Med. 2009 Apr;30(4):279-84. doi: 10.1055/s-0028-1104588. Epub 2009 Feb 6. — View Citation

Bhammar DM, Stickford JL, Bernhardt V, Babb TG. Verification of Maximal Oxygen Uptake in Obese and Nonobese Children. Med Sci Sports Exerc. 2017 Apr;49(4):702-710. doi: 10.1249/MSS.0000000000001170. — View Citation

Hawkins MN, Raven PB, Snell PG, Stray-Gundersen J, Levine BD. Maximal oxygen uptake as a parametric measure of cardiorespiratory capacity. Med Sci Sports Exerc. 2007 Jan;39(1):103-7. Erratum in: Med Sci Sports Exerc. 2007 Mar;39(3):574. — View Citation

Kaminsky LA, Whaley MH. Evaluation of a new standardized ramp protocol: the BSU/Bruce Ramp protocol. J Cardiopulm Rehabil. 1998 Nov-Dec;18(6):438-44. — View 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. — View Citation

Löllgen H, Leyk D. Exercise Testing in Sports Medicine. Dtsch Arztebl Int. 2018 Jun 15;115(24):409-416. doi: 10.3238/arztebl.2018.0409. Review. — View 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. Review. — View Citation

Midgley AW, Carroll S, Marchant D, McNaughton LR, Siegler J. Evaluation of true maximal oxygen uptake based on a novel set of standardized criteria. Appl Physiol Nutr Metab. 2009 Apr;34(2):115-23. doi: 10.1139/H08-146. — View Citation

Schaun GZ. The Maximal Oxygen Uptake Verification Phase: a Light at the End of the Tunnel? Sports Med Open. 2017 Dec 8;3(1):44. doi: 10.1186/s40798-017-0112-1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 MAX	maximal oxygen consumption	through study completion, an average of 1 year
Primary	RPE-rate of perceived exertion	rate of perceived exertion on a 10 point modified Borg scale	through study completion, an average of 1 year
Primary	Max heart rate	Max heart rate	through study completion, an average of 1 year