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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclo Ergometer Exercise in Children | Experimental | Comparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among children |
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| Treadmill Exercise in Children | Experimental | Comparison of gas exchange kinetics and heart rate in treadmill exercises among children |
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| Cyclo Ergometer Exercise in Adolescents | Experimental | Comparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among adolescents |
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| Treadmill Exercise in Adolescents | Experimental | Comparison of gas exchange kinetics and heart rate in treadmill exercises among adolescents |
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| Cyclo Ergometer Exercise in Adults | Experimental | Comparison of gas exchange kinetics and heart rate in cyclo ergometer exercises among adults |
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| Treadmill Exercise in Adults |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Training | Other | Comparison of stationary bike and treadmill exercise among children, adolescents and adults |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Oxygen Uptake (VO2) Measurements During Exercise | Breath by breath gas exchange VO2 in response to exercise. | At least 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate (HR) Measurements During Exercise | Heart Rate (HR) values in response to exercise | At least 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Exercise and Genomics Research Center, University of California, Irvine | Irvine | California | 92697/92617 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treadmill and Cyclo Ergometer Exercise in Children | Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises Exercise Training: Comparison of stationary bike and treadmill exercise among children |
| FG001 | Treadmill and Cyclo Ergometer Exercise in Adolescents | Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises Exercise Training: Comparison of cyclo ergometer and treadmill exercise among adolescents |
| FG002 | Treadmill and Cyclo Ergometer Exercise in Adults | Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises Exercise Training: Comparison of cyclo ergometer and treadmill exercise among Adults |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treadmill and Cycle Ergometer Exercise in Children | Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises Exercise Training: Comparison of cyclo ergometer and treadmill exercise among children |
| BG001 | Treadmill and Cycle Ergometer Exercise in Adolescents |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Oxygen Uptake (VO2) Measurements During Exercise | Breath by breath gas exchange VO2 in response to exercise. | Posted | Mean | Standard Deviation | L/min | At least 48 hours |
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During the 30 min exercise for each of the two sessions.
Not different from clinicaltrial.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cycle Ergometer Exercise in Children | Comparison of gas exchange kinetics between cyclo ergometer exercises Exercise Training: Comparison of cyclic ergometer exercise among children |
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The same order of exercise test modalities may influence the second test session. Supramaximal test was not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Horvath (Administrative Contact) | University of California, Irvine | (714) 456-8248 | phorvath@hs.uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2026 | Jan 30, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Experimental |
Comparison of gas exchange kinetics and heart rate in treadmill exercises among adults |
|
Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises Exercise Training: Comparison of cyclo ergometer and treadmill exercise among Adolescents |
| BG002 | Treadmill and Cycle Ergometer Exercise in Adults | Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises Exercise Training: Comparison of cyclo ergometer and treadmill exercise among Adults |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Comparison of submaximal CPET variables between treadmill and cyclo ergometer exercises among adults |
|
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| Secondary | Heart Rate (HR) Measurements During Exercise | Heart Rate (HR) values in response to exercise | Posted | Mean | Standard Deviation | beat/min | At least 48 hours |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Treadmill Exercise in Children | Comparison of gas exchange kinetics between treadmill exercises Exercise Training: Comparison of treadmill exercise among children | 0 | 41 | 0 | 41 | 0 | 41 |
| EG002 | Cycle Ergometer Exercise in Adolescents | Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises Exercise Training: Comparison of cyclic ergometer and treadmill exercise among adolescents | 0 | 19 | 0 | 19 | 0 | 19 |
| EG003 | Treadmill Exercise in Adolescents | Comparison of gas exchange kinetics between treadmill exercises Exercise Training: Comparison of cyclic ergometer exercise among adolescents | 0 | 34 | 0 | 34 | 0 | 34 |
| EG004 | Cycle Ergometer Exercise in Adults | Comparison of gas exchange kinetics between cyclo ergometer exercises Exercise Training: Comparison of cyclic ergometer exercise among adults | 0 | 41 | 0 | 41 | 0 | 41 |
| EG005 | Treadmill Exercise in Adults | Comparison of gas exchange kinetics between treadmill exercises Exercise Training: Comparison of cyclic ergometer exercise among adults | 0 | 19 | 0 | 19 | 0 | 19 |
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