Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gas Exchange Kinetics and Work Load During Exercise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03770507
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Shlomit Aizik, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Methods of Exercise in Children Other: Exercise Training Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Gas Exchange Kinetics and Work Load During Different Exercise Protocols in Healthy Children and Young Adults
Actual Study Start Date : April 25, 2016
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treadmill Exercise in Adolescents and Adults
Comparison of gas exchange kinetics between treadmill and cyclo ergometer exercises
Other: Exercise Training
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
Other: Exercise Training
Comparison of stationary bike and treadmill exercise among adolescents and adults




Primary Outcome Measures :
  1. Maximum Oxygen Uptake (VO2) measurements during exercise [ Time Frame: 4 weeks ]
    Breath by breath gas exchange VO2 in response to exercise.

  2. Carbon Dioxide Production (VCO2) measurements during exercise [ Time Frame: 4 weeks ]
    Breath by breath gas exchange VCO2 in response to exercise

  3. Minute Ventilation (VE) measurements during exercise [ Time Frame: 4 weeks ]
    Breath by breath gas exchange Minute ventilation (VE) in response to exercise

  4. Heart Rate (HR) measurements during exercise [ Time Frame: 4 weeks ]
    Breath by breath gas exchange HR values in response to exercise


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Lean body mass measurements by Dial X-Ray Absorbiometry (DXA) [ Time Frame: 4 weeks ]
    lean body mass in kg's

  4. Fat percentage measurements by Dial X-Ray Absorbiometry (DXA) [ Time Frame: 4 weeks ]
    percent of fat tissue

  5. Fat free mass measurements by Dial X-Ray Absorbiometry (DXA) [ Time Frame: 4 weeks ]
    fat free mass in kg's

  6. Bone mass measurements by Dial X-Ray Absorbiometry (DXA) [ Time Frame: 4 weeks ]
    bone mass in kg's

  7. Muscle mass measurements [ Time Frame: 4 weeks ]
    Muscle mass in kg's will be determined by ultrasound

  8. 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.

  9. Measurement of tissue oxygenation [ Time Frame: 4 weeks ]
    Concentration of oxy- and de-oxyhemoglobin will be measured non-invasively

  10. Measurements of breath rate [ Time Frame: 4 weeks ]
    Respiratory sensors will be used to evaluate breath rate

  11. Measurements of lung volume [ Time Frame: 4 weeks ]
    Spirometry will be used to evaluate lung volume



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770507


Contacts
Layout table for location contacts
Contact: Fadia Haddad, Ph.D. (949) 824-6810 fhaddad@uci.edu
Contact: Peter Horvath, Ph.D. (714) 456-8248 phorvath@uci.edu

Locations
Layout table for location information
United States, California
Pediatric Exercise and Genomics Research Center, University of California, Irvine Recruiting
Irvine, California, United States, 92697/92617
Contact: Fadia Haddad, Ph.D.    949-824-6810    fhaddad@uci.edu   
Sponsors and Collaborators
Shlomit Aizik
  Study Documents (Full-Text)

Documents provided by Shlomit Aizik, University of California, Irvine:
Study Protocol  [PDF] January 26, 2018


Layout table for additonal information
Responsible Party: Shlomit Aizik, Associate Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03770507     History of Changes
Other Study ID Numbers: 2015-2467
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: January 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No