Cardio-Pulmonary Exercise Testing in Healthy Population

NCT ID: NCT05242211

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-03

Study Completion Date

2022-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Healthy Obesity, Metabolically

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy

Healthy participants will do both cycle ergometer and treadmill exercise

Group Type OTHER

exercise test

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy 18-55

Exclusion Criteria

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

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Gur Mainzer

Head of the pediatric cardiology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gur Mainzer, MD

Role: PRINCIPAL_INVESTIGATOR

The Baruch Padeh Medical Center, Poriya

Locations

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The BARUCH PADEH Medical Center, Poriya

Tiberias, The Lower Galilee, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Gur Mainzer, MD

Role: CONTACT

+972543078940

Einat Kodesh, PhD

Role: CONTACT

+972523489854

References

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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.

Reference Type BACKGROUND
PMID: 19199208 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27875494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9857276 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17218891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19370041 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29218470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19706003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28510504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29968559 (View on PubMed)

Other Identifiers

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0020-17-POR

Identifier Type: -

Identifier Source: org_study_id

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