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Cardio-Pulmonary Exercise Testing in Healthy Population

Sponsor
The Baruch Padeh Medical Center, Poriya (Other)
Overall Status
Recruiting
CT.gov ID
NCT05242211
Collaborator
(none)
90
Enrollment
1
Location
1
Arm
34.9
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: exercise test
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Protocols Adjustments for Cardio-Pulmonary Exercise Testing in Healthy Population
Actual Study Start Date :
Nov 3, 2019
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. VO2 MAX [through study completion, an average of 1 year]

    maximal oxygen consumption

  2. RPE-rate of perceived exertion [through study completion, an average of 1 year]

    rate of perceived exertion on a 10 point modified Borg scale

  3. Max heart rate [through study completion, an average of 1 year]

    Max heart rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy 18-55
Exclusion Criteria:
  • Physical activity limitation due to orthopedic , neurological and cognition deficit Pregnancy children

Contacts and Locations

Locations

Site City State Country Postal Code
1 The BARUCH PADEH Medical Center, Poriya Teverya The Lower Galilee Israel 15208

Sponsors and Collaborators

  • The Baruch Padeh Medical Center, Poriya

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Gur Mainzer, Head of the pediatric cardiology department, The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT05242211
Other Study ID Numbers:
  • 0020-17-POR
First Posted:
Feb 16, 2022
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gur Mainzer, Head of the pediatric cardiology department, The Baruch Padeh Medical Center, Poriya
exercise
maximal exercise test
exercise protocol
metabolic
Additional relevant MeSH terms:
Obesity, Metabolically Benign

Study Results

No Results Posted as of Feb 16, 2022