Methods of Exercise in Children Clinical Trial
Official title:
Gas Exchange Kinetics and Work Load During Different Exercise Protocols in Healthy Children and Young Adults
| NCT number | NCT03770507 |
| Other study ID # | 2015-2467 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 25, 2016 |
| Est. completion date | April 25, 2016 |
| Verified date | February 2021 |
| Source | University of California, Irvine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | April 25, 2016 |
| Est. primary completion date | April 25, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 7 Years to 35 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pediatric Exercise and Genomics Research Center, University of California, Irvine | Irvine | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Irvine |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum Oxygen Uptake (VO2) measurements during exercise | Breath by breath gas exchange VO2 in response to exercise. | 4 weeks | |
| Primary | Carbon Dioxide Production (VCO2) measurements during exercise | Breath by breath gas exchange VCO2 in response to exercise | 4 weeks | |
| Primary | Minute Ventilation (VE) measurements during exercise | Breath by breath gas exchange Minute ventilation (VE) in response to exercise | 4 weeks | |
| Primary | Heart Rate (HR) measurements during exercise | Breath by breath gas exchange HR values in response to exercise | 4 weeks | |
| Secondary | Physical fitness evaluation | 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 | |
| Secondary | Leisure time evaluation | 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 | |
| Secondary | Lean body mass measurements by Dial X-Ray Absorbiometry (DXA) | lean body mass in kg's | 4 weeks | |
| Secondary | Fat percentage measurements by Dial X-Ray Absorbiometry (DXA) | percent of fat tissue | 4 weeks | |
| Secondary | Fat free mass measurements by Dial X-Ray Absorbiometry (DXA) | fat free mass in kg's | 4 weeks | |
| Secondary | Bone mass measurements by Dial X-Ray Absorbiometry (DXA) | bone mass in kg's | 4 weeks | |
| Secondary | Muscle mass measurements | Muscle mass in kg's will be determined by ultrasound | 4 weeks | |
| Secondary | Puberty status measurements by using a growth and development questionnaire | 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 | |
| Secondary | Measurement of tissue oxygenation | Concentration of oxy- and de-oxyhemoglobin will be measured non-invasively | 4 weeks | |
| Secondary | Measurements of breath rate | Respiratory sensors will be used to evaluate breath rate | 4 weeks | |
| Secondary | Measurements of lung volume | Spirometry will be used to evaluate lung volume | 4 weeks |