CClinicalTrials.gg
CompletedNCT03770507Updated Mar 23, 2026Results posted

Gas Exchange Kinetics and Work Load During Exercise

An interventional study of Exercise Training in Methods of Exercise in Children, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 7 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-23.

Sponsored by University of California, Irvine · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Apr 2016, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
7 Years to 35 Years
Sex
All
01

Study summary

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.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.

Read the detailed description

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.

02

Conditions studied

  • Methods of Exercise in Children
03

In context

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
94 participants (actual)

Study arms

  • Experimental
    Cyclo Ergometer Exercise in Children

    Comparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among children

    Other: Exercise Training

  • Experimental
    Treadmill Exercise in Children

    Comparison of gas exchange kinetics and heart rate in treadmill exercises among children

    Other: Exercise Training

  • Experimental
    Cyclo Ergometer Exercise in Adolescents

    Comparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among adolescents

    Other: Exercise Training

  • Experimental
    Treadmill Exercise in Adolescents

    Comparison of gas exchange kinetics and heart rate in treadmill exercises among adolescents

    Other: Exercise Training

  • Experimental
    Cyclo Ergometer Exercise in Adults

    Comparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among adults

    Other: Exercise Training

  • Experimental
    Treadmill Exercise in Adults

    Comparison of gas exchange kinetics and heart rate in treadmill exercises among adults

    Other: Exercise Training

Interventions

  • OtherExercise Training

    Comparison of stationary bike and treadmill exercise among children, adolescents and adults

06

What researchers measure

Primary outcomes

  1. Maximum Oxygen Uptake (VO2) Measurements During Exercise

    Breath by breath gas exchange VO2 in response to exercise.

    Time frame: At least 48 hours

Secondary outcomes

  1. Heart Rate (HR) Measurements During Exercise

    Heart Rate (HR) values in response to exercise

    Time frame: At least 48 hours

07

Results

Posted Mar 23, 2026
Limitations and caveats
The same order of exercise test modalities may influence the second test session. Supramaximal test was not performed.

Participant flow

Participant flow — Overall Study
MilestoneTreadmill and Cyclo Ergometer Exercise in ChildrenTreadmill and Cyclo Ergometer Exercise in AdolescentsTreadmill and Cyclo Ergometer Exercise in Adults
Started344119
Completed344119
Not completed000

Outcome measures

PrimaryMaximum Oxygen Uptake (VO2) Measurements During Exercise

Breath by breath gas exchange VO2 in response to exercise.

Time frame:
At least 48 hours
Reported as:
Mean · L/min
Maximum Oxygen Uptake (VO2) Measurements During Exercise
L/minCyclo Ergometer andTreadmill Exercise in ChildrenCyclo Ergometer and Treadmill Exercise in AdolescentsCyclo Ergometer and Treadmill Exercise in Adults
Cyclo Ergometer Peak VO2 (L/min)1.6 ± 0.42.8 ± 0.63.2 ± 0.8
Treadmill Peak V02 (L/min)1.7 ± 0.42.9 ± 0.53.5 ± 0.5
SecondaryHeart Rate (HR) Measurements During Exercise

Heart Rate (HR) values in response to exercise

Time frame:
At least 48 hours
Reported as:
Mean · beat/min
Heart Rate (HR) Measurements During Exercise
beat/minCyclo Ergometer and Treadmill Exercise in ChildrenCyclo Ergometer and Treadmill Exercise in AdolescentsCyclo Ergometer and Treadmill Exercise in Adults
Cyclo Ergometer Peak HR (beat/min)197.2 ± 8.8195.5 ± 9.8186.6 ± 9.9
Treadmill Peak HR (beat/min)194.6 ± 8.4198.1 ± 8.1190.4 ± 10.7

Adverse events

Collected over During the 30 min exercise for each of the two sessions.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cycle Ergometer Exercise in Children0/34 (0%)0/34 (0%)0/34 (0%)
Treadmill Exercise in Children0/41 (0%)0/41 (0%)0/41 (0%)
Cycle Ergometer Exercise in Adolescents0/19 (0%)0/19 (0%)0/19 (0%)
Treadmill Exercise in Adolescents0/34 (0%)0/34 (0%)0/34 (0%)
Cycle Ergometer Exercise in Adults0/41 (0%)0/41 (0%)0/41 (0%)
Treadmill Exercise in Adults0/19 (0%)0/19 (0%)0/19 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treadmill and Cycle Ergometer Exercise in ChildrenTreadmill and Cycle Ergometer Exercise in AdolescentsTreadmill and Cycle Ergometer Exercise in AdultsTotal
<=18 years3441075
Between 18 and 65 years001919
>=65 years0000
Age, Continuous
Age, Continuous(years)Treadmill and Cycle Ergometer Exercise in ChildrenTreadmill and Cycle Ergometer Exercise in AdolescentsTreadmill and Cycle Ergometer Exercise in AdultsTotal
Mean9.8 ± 1.416.2 ± 1.627.7 ± 3.517.9 ± 2.1
Sex: Female, Male
Sex: Female, Male(Participants)Treadmill and Cycle Ergometer Exercise in ChildrenTreadmill and Cycle Ergometer Exercise in AdolescentsTreadmill and Cycle Ergometer Exercise in AdultsTotal
Female16231150
Male1818844
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Treadmill and Cycle Ergometer Exercise in ChildrenTreadmill and Cycle Ergometer Exercise in AdolescentsTreadmill and Cycle Ergometer Exercise in AdultsTotal
Ethnicity (Hispanic/Latino)1304
Race (White)29241265
Race (Asian)317626
Race (African-American)2013
Region of Enrollment
Region of Enrollment(participants)Treadmill and Cycle Ergometer Exercise in ChildrenTreadmill and Cycle Ergometer Exercise in AdolescentsTreadmill and Cycle Ergometer Exercise in AdultsTotal
United States34411994
08

Study locations

1 site
  • Pediatric Exercise and Genomics Research Center, University of California, Irvine
    Irvine, California 92697/92617, United States
09

References and documents

Study documents

  • Statistical analysis plan · Jan 30, 2026

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03770507
Lead sponsor
University of California, Irvine
Responsible party
Dan Cooper (Professor, University of California, Irvine) — Principal investigator
First posted
Dec 10, 2018
Start date
Apr 26, 2016
Primary completion
Dec 1, 2016
Completion
Dec 1, 2016
Results posted
Mar 23, 2026
Last update
Mar 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion