- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01695785
Perception of Physical Exertion in Healthy Weight and Obese Adolescents
September 9, 2015 updated by: Connie Tompkins, PhD, University of Vermont
Perception of Physical Exertion in Healthy Weight and Obese Adolescents: A Pilot Study
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.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
40
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
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Vermont
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Burlington, Vermont, United States, 05405
- University of Vermont
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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
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy weight and obese adolescents from the community
Description
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
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
Cohorts and Interventions
Group / Cohort |
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Healthy weight
greater than or equal to the 5th to less than the 85th BMI percentile
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Obese
greater than or equal to the 95th BMI percentile
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physiological responses to submaximal and maximal treadmill exercise
Time Frame: 7-10 days
|
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.
|
7-10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptual responses to submaximal and maximal treadmill exercise
Time Frame: 7-10 days
|
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.
|
7-10 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity intention
Time Frame: 7 days
|
Subjects will be asked how much physical activity they plan or intend to participate in for the next 7 days.
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7 days
|
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Physical activity behavior
Time Frame: 7 days
|
Subjects will be asked how much physical activity they participated in for the past 7 days.
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7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Connie Tompkins, PhD, University of Vermont
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
June 1, 2012
Primary Completion (Anticipated)
August 1, 2016
Study Completion (Anticipated)
August 1, 2016
Study Registration Dates
First Submitted
September 24, 2012
First Submitted That Met QC Criteria
September 27, 2012
First Posted (Estimate)
September 28, 2012
Study Record Updates
Last Update Posted (Estimate)
September 10, 2015
Last Update Submitted That Met QC Criteria
September 9, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- M12-079
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.
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