Cardio-Pulmonary Exercise Testing in Healthy Population

February 6, 2022 updated by: Gur Mainzer, The Baruch Padeh Medical Center, Poriya

Protocols Adjustments for Cardio-Pulmonary Exercise Testing in Healthy Population

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
    • The Lower Galilee
      • Teverya, The Lower Galilee, Israel, 15208
        • Recruiting
        • The Baruch Padeh Medical Center, Poriya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy 18-55

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Healthy
Healthy participants will do both cycle ergometer and treadmill exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VO2 MAX
Time Frame: through study completion, an average of 1 year
maximal oxygen consumption
through study completion, an average of 1 year
RPE-rate of perceived exertion
Time Frame: through study completion, an average of 1 year
rate of perceived exertion on a 10 point modified Borg scale
through study completion, an average of 1 year
Max heart rate
Time Frame: through study completion, an average of 1 year
Max heart rate
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Baruch Padeh Medical Center, Poriya

Investigators

  • Principal Investigator: Gur Mainzer, MD, The Baruch Padeh Medical Center, Poriya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 3, 2019

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

December 19, 2021

First Submitted That Met QC Criteria

February 6, 2022

First Posted (ACTUAL)

February 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 6, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0020-17-POR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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