- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03770507
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Withdrawn
Conditions
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.
Sponsor
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.
Clinical Trials on Methods of Exercise in Children
-
Biruni UniversityCompletedExercise Training | Recovery MethodsTurkey
-
Children's Hospital of Eastern OntarioRecruitingPharmacokinetics of Celecoxib in ChildrenCanada
-
National Cheng-Kung University HospitalMinistry of Science and Technology, TaiwanCompletedEffects of Aerobic Exercise in Pregnant Women
-
Suleyman Demirel UniversityCompletedOral Findings in Children of Multiple and Single Births | Radiographic Evaluation of Oral Findings in Children of Multiple and Single BirthsTurkey
-
Assistance Publique - Hôpitaux de ParisCompletedUse of Methylphenidate in Children and AdolescentsFrance
-
Ohio State UniversityWithdrawnAdministration Methods of Labor AnalgesiaUnited States
-
Assistance Publique - Hôpitaux de ParisCompletedOutpatient Use of Analgesics in Children and AdolescentsFrance
-
Centre des Sciences du Goût et de l'AlimentationEuropean Community; Regional Council of BurgundyCompletedConditioning of Caloric Adjustment and Liking in ChildrenFrance
-
Hadassah Medical OrganizationIsrael Cancer AssociationCompletedCancer | Exercise | Children
Clinical Trials on Exercise Training
-
University of British ColumbiaMichael Smith Foundation for Health ResearchCompleted
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Universidade Norte do ParanáCompleted
-
University of Colorado, DenverVA Eastern Colorado Health Care SystemCompletedHealthy | Overweight | Type 2 Diabetes Mellitus | Cardiovascular Risk FactorUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
-
Universita di VeronaRecruiting
-
Hacettepe UniversityCompleted
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of LeipzigCompletedImpact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CADStable Coronary Artery DiseaseGermany
-
Helse Stavanger HFStavanger Health ResearchCompletedVentricular TachycardiaNorway