Perception of Physical Exertion in Healthy Weight and Obese Adolescents

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Connie Tompkins, PhD, University of Vermont
ClinicalTrials.gov Identifier:
NCT01695785
First received: September 24, 2012
Last updated: September 9, 2015
Last verified: September 2015
  Purpose
Little is known regarding the relationship between perceived and physiological exertion in adolescents. The purpose of this study is to investigate the association between physiological and perceptual markers of effort during exercise and the relationship of these markers to other health-related behaviors in healthy weight and obese adolescents.

Condition
Physiological Response to Exercise
Perception of Exercise Difficulty

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Perception of Physical Exertion in Healthy Weight and Obese Adolescents: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Physiological responses to submaximal and maximal treadmill exercise [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]
    Physiological responses to submaximal and maximal treadmill exercise will be assessed during the exercise test and immediately upon completion of the exercise test. The submaximal treadmill exercise will take place at visit 1 and the maximal treadmill exercise test will take place at the 2nd and final visit which will occur 7-10 days from the 1st visit. There is no intervention between visits.


Secondary Outcome Measures:
  • Perceptual responses to submaximal and maximal treadmill exercise [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]
    Perceptual responses to submaximal and maximal treadmill exercise will be assessed during the exercise test and immediately upon completion of the exercise test. The submaximal treadmill exercise will take place at visit 1 and the maximal treadmill exercise test will take place at the 2nd and final visit which will occur 7-10 days from the 1st visit. There is no intervention between visits.


Other Outcome Measures:
  • Physical activity intention [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Subjects will be asked how much physical activity they plan or intend to participate in for the next 7 days.

  • Physical activity behavior [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Subjects will be asked how much physical activity they participated in for the past 7 days.


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy weight
greater than or equal to the 5th to less than the 85th BMI percentile
Obese
greater than or equal to the 95th BMI percentile

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy weight and obese adolescents from the community
Criteria

Inclusion Criteria:

  • Healthy weight (>5th-85th BMI percentile) or obese (>95th BMI percentile)
  • male and female adolescents, 13-18 years
  • Approval to participate in a submaximal and maximal treadmill test received from the adolescent's pediatrician.

Exclusion Criteria:

  • Underweight (<5th BMI percentile)
  • overweight (85 - <95th BMI percentile)
  • evidence/reporting of significant cardiovascular disease, cardiac arrhythmias, liver disease, or the chronic use of medications including diuretics, steroids and adrenergic-stimulating agents.
  • Adolescents with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions.
  • Approval to participate in a submaximal and maximal treadmill test from the adolescent's pediatrician not obtained
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695785

Locations
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Connie Tompkins, PhD University of Vermont
  More Information

Responsible Party: Connie Tompkins, PhD, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT01695785     History of Changes
Other Study ID Numbers: M12-079 
Study First Received: September 24, 2012
Last Updated: September 9, 2015
Health Authority: United States: UVM IRB Committee on Human Research in the Medical Sciences

ClinicalTrials.gov processed this record on August 22, 2016