Gas Exchange Kinetics and Work Load During Exercise

February 9, 2021 updated by: University of California, Irvine

Gas Exchange Kinetics and Work Load During Different Exercise Protocols in Healthy Children and Young Adults

The purpose of this research study is to understand how different kinds of exercise affect the human body and the health of the heart and lungs. For example, some people like to exercise continuously for relatively long periods of time while others like to exercise for short periods of time with rest periods in between. Children tend to exercise in frequent bouts of brief exercise interspersed with periods of rest. Also, some people like running or treadmill exercise while others like to work out on stationary bicycles. To date, standard exercise testing is based on a century-old paradigm used predominantly for adults that involves maximal exercise protocols (cardiopulmonary exercise testing-CPET). Moreover, different but widely used exercise modalities such as cycle ergometer and treadmills are currently impossible to compare in children, and this has limited the clinical and research application of such testing in the pediatric age-range. A major premise of this laboratory is that laboratory testing of cardiopulmonary fitness in children should be based on protocols that mimic naturally occurring patterns of exercise in children, rather than those that have been artificially employed to assess maximal efforts in adults. This research project designed to begin the process of systematically identifying protocols can be best used for children and young adults. Participants will exercise in different protocols on a bicycle ergometer or treadmill. This research could lead to improved and more accurate fitness assessment and pave the way to an improved personalized exercise program in health and illness.

Study Overview

Status

Withdrawn

Intervention / Treatment

Study Type

Interventional

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 Locations

    • California
      • Irvine, California, United States, 92697/92617
        • Pediatric Exercise and Genomics Research Center, University of California, Irvine

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

7 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between the ages of 7-35 years old without any known respiratory, cardiac or metabolic disease
  • Determined to be in good health by preparticipation history
  • No evidence of disease or disability that would impair participation in an exercise testing
  • No chronic prescribed medication

Exclusion Criteria:

  • Other limitation which in the eyes of the physician that would preclude ability to perform exercise testing
  • Use of illegal drugs or abuse of alcohol
  • Pregnancy or breastfeeding

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treadmill Exercise in Adolescents and Adults
Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises
Comparison of stationary bike and treadmill exercise among adolescents and adults
Experimental: Cyclo Ergometer Exercise in Adolescents and Adults
Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises
Comparison of stationary bike and treadmill exercise among adolescents and adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Oxygen Uptake (VO2) measurements during exercise
Time Frame: 4 weeks
Breath by breath gas exchange VO2 in response to exercise.
4 weeks
Carbon Dioxide Production (VCO2) measurements during exercise
Time Frame: 4 weeks
Breath by breath gas exchange VCO2 in response to exercise
4 weeks
Minute Ventilation (VE) measurements during exercise
Time Frame: 4 weeks
Breath by breath gas exchange Minute ventilation (VE) in response to exercise
4 weeks
Heart Rate (HR) measurements during exercise
Time Frame: 4 weeks
Breath by breath gas exchange HR values in response to exercise
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical fitness evaluation
Time Frame: 4 weeks
Physical activity questionnaire - Points are given to each level of activity, the mean of these points are taken which will give a physical activity summary score
4 weeks
Leisure time evaluation
Time Frame: 4 weeks
Godin Leisure Time Exercise questionnaire - Total score will be measured Godin Leisure Time Exercise questionnaire - Total leisure activity score is calculated from points given to each level of activity from light to strenuous
4 weeks
Lean body mass measurements by Dial X-Ray Absorbiometry (DXA)
Time Frame: 4 weeks
lean body mass in kg's
4 weeks
Fat percentage measurements by Dial X-Ray Absorbiometry (DXA)
Time Frame: 4 weeks
percent of fat tissue
4 weeks
Fat free mass measurements by Dial X-Ray Absorbiometry (DXA)
Time Frame: 4 weeks
fat free mass in kg's
4 weeks
Bone mass measurements by Dial X-Ray Absorbiometry (DXA)
Time Frame: 4 weeks
bone mass in kg's
4 weeks
Muscle mass measurements
Time Frame: 4 weeks
Muscle mass in kg's will be determined by ultrasound
4 weeks
Puberty status measurements by using a growth and development questionnaire
Time Frame: 4 weeks
Children will fill a standard Tanner Staging questionnaire. The Tanner staging defines the physical characteristics of individuals. A Tanner stage status assigned to each child depending on their primary and secondary sexual development characteristics.
4 weeks
Measurement of tissue oxygenation
Time Frame: 4 weeks
Concentration of oxy- and de-oxyhemoglobin will be measured non-invasively
4 weeks
Measurements of breath rate
Time Frame: 4 weeks
Respiratory sensors will be used to evaluate breath rate
4 weeks
Measurements of lung volume
Time Frame: 4 weeks
Spirometry will be used to evaluate lung volume
4 weeks

Collaborators and Investigators

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

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)

April 25, 2016

Primary Completion (Actual)

April 25, 2016

Study Completion (Actual)

April 25, 2016

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-2467

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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