Cardio-Pulmonary Exercise Testing in Healthy Population

NCT05242211 | Unknown

• 1 other identifier: 0020-17-POR
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Obesity, Metabolically

Keywords

exercise; maximal exercise test; exercise protocol; metabolic

Outcome Measures

Primary Outcomes (3)

• VO2 MAX

  maximal oxygen consumption

  through study completion, an average of 1 year

• RPE-rate of perceived exertion

  rate of perceived exertion on a 10 point modified Borg scale

  through study completion, an average of 1 year

• Max heart rate

  Max heart rate

  through study completion, an average of 1 year

Study Arms (1)

Healthy

OTHER

Healthy participants will do both cycle ergometer and treadmill exercise

Other: exercise test

Interventions

exercise test OTHER

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.

Healthy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy 18-55

You may not qualify if:

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

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

Related 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.

  PMID: 19199208 BACKGROUND

• 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.

  PMID: 27875494 BACKGROUND

• 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. doi: 10.1097/00008483-199811000-00006.

  PMID: 9857276 BACKGROUND

• 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. doi: 10.1249/01.mss.0000241641.75101.64.

  PMID: 17218891 BACKGROUND

• 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.

  PMID: 19370041 BACKGROUND

• 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.

  PMID: 29218470 BACKGROUND

• 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.

  PMID: 19706003 BACKGROUND

• 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.

  PMID: 28510504 BACKGROUND

• 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.

  PMID: 29968559 BACKGROUND

MeSH Terms

Conditions

Obesity, Metabolically Benign; Motor Activity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the pediatric cardiology department

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2021
• First Posted: February 16, 2022
• Study Start: November 3, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)