Methods of Exercise in ChildrenNCT03770507
Gas Exchange Kinetics and Work Load During Exercise
A study testing Exercise Training in people with Methods of Exercise in Children, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Methods of Exercise in Children
- What is being tested?
- Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2016to 1 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Exercise and Genomics Research Center, University of California, Irvine
Irvine, California, 92697/92617
About this study
Official title: 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.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.
- Conditions
- Methods of Exercise in Children
- Being tested
- Exercise Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
Comparison of stationary bike and treadmill exercise among children, adolescents and adults
| Study group | Role | What they receive |
|---|---|---|
| Cyclo Ergometer Exercise in Children | Experimental | Comparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among children Receives: Other: Exercise Training |
| Treadmill Exercise in Children | Experimental | Comparison of gas exchange kinetics and heart rate in treadmill exercises among children Receives: Other: Exercise Training |
| Cyclo Ergometer Exercise in Adolescents | Experimental | Comparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among adolescents Receives: Other: Exercise Training |
| Treadmill Exercise in Adolescents | Experimental | Comparison of gas exchange kinetics and heart rate in treadmill exercises among adolescents Receives: Other: Exercise Training |
| Cyclo Ergometer Exercise in Adults | Experimental | Comparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among adults Receives: Other: Exercise Training |
| Treadmill Exercise in Adults | Experimental | Comparison of gas exchange kinetics and heart rate in treadmill exercises among adults Receives: Other: Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Oxygen Uptake (VO2) Measurements During Exercise
Breath by breath gas exchange VO2 in response to exercise.
Measured: At least 48 hours
Secondary outcomes (1)
Heart Rate (HR) Measurements During Exercise
Heart Rate (HR) values in response to exercise
Measured: At least 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start26 Apr 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Methods of Exercise in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Cooper, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770507
- Sponsor's protocol ID
- 20152467
- Status last verified
- Jul 2025
- First submitted
- 8 Nov 2018
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gas Exchange Kinetics and Work Load During Different Exercise Protocols in Healthy Children and Young Adults
- ClinicalTrials.gov ID
- NCT03770507
- Acronym / sponsor ID
- 20152467
- Conditions
- Methods of Exercise in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cyclo Ergometer Exercise in Children | Experimental | Other: Exercise TrainingComparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among children |
| Treadmill Exercise in Children | Experimental | Other: Exercise TrainingComparison of gas exchange kinetics and heart rate in treadmill exercises among children |
| Cyclo Ergometer Exercise in Adolescents | Experimental | Other: Exercise TrainingComparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among adolescents |
| Treadmill Exercise in Adolescents | Experimental | Other: Exercise TrainingComparison of gas exchange kinetics and heart rate in treadmill exercises among adolescents |
| Cyclo Ergometer Exercise in Adults | Experimental | Other: Exercise TrainingComparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among adults |
| Treadmill Exercise in Adults | Experimental | Other: Exercise TrainingComparison of gas exchange kinetics and heart rate in treadmill exercises among adults |
Who may qualify
- Ages
- 7 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingComparison of stationary bike and treadmill exercise among children, adolescents and adults | Other | Cyclo Ergometer Exercise in Adolescents, Cyclo Ergometer Exercise in Adults, Cyclo Ergometer Exercise in Children, Treadmill Exercise in Adolescents, Treadmill Exercise in Adults, Treadmill Exercise in Children |
Primary outcome
Maximum Oxygen Uptake (VO2) Measurements During Exercise
Time frame: At least 48 hours
Breath by breath gas exchange VO2 in response to exercise.
1 secondary outcome
Heart Rate (HR) Measurements During Exercise
Time frame: At least 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training in people with Methods of Exercise in Children, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Oxygen Uptake (VO2) Measurements During Exercise (time frame: At least 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.