Clinical trial NCT03770507: Gas Exchange Kinetics and Work Load During Exercise
Official title: Gas Exchange Kinetics and Work Load During Different Exercise Protocols in Healthy Children and Young Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Methods of Exercise in Children
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Oxygen Uptake (VO2) measurements during exercise
timeFrame: 4 weeks
measure: Carbon Dioxide Production (VCO2) measurements during exercise
timeFrame: 4 weeks
measure: Minute Ventilation (VE) measurements during exercise
timeFrame: 4 weeks
measure: Heart Rate (HR) measurements during exercise
timeFrame: 4 weeks
Secondary outcomes:
measure: Physical fitness evaluation
timeFrame: 4 weeks
measure: Leisure time evaluation
timeFrame: 4 weeks
measure: Lean body mass measurements by Dial X-Ray Absorbiometry (DXA)
timeFrame: 4 weeks
measure: Fat percentage measurements by Dial X-Ray Absorbiometry (DXA)
timeFrame: 4 weeks
measure: Fat free mass measurements by Dial X-Ray Absorbiometry (DXA)
timeFrame: 4 weeks
measure: Bone mass measurements by Dial X-Ray Absorbiometry (DXA)
timeFrame: 4 weeks
measure: Muscle mass measurements
timeFrame: 4 weeks
measure: Puberty status measurements by using a growth and development questionnaire
timeFrame: 4 weeks
measure: Measurement of tissue oxygenation
timeFrame: 4 weeks
measure: Measurements of breath rate
timeFrame: 4 weeks
measure: Measurements of lung volume
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Pediatric Exercise and Genomics Research Center, University of California, Irvine
state: California
Study officials:
References: