Physiological Response to ExerciseNCT01695785
Perception of Physical Exertion in Healthy Weight and Obese Adolescents
An observational study of Physiological Response to Exercise and Perception of Exercise Difficulty, run by University of Vermont at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Response to Exercise, Perception of Exercise Difficulty
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy weight and obese adolescents from the community
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological responses to submaximal and maximal treadmill exercise
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.
Measured: 7-10 days
Secondary outcomes (1)
Perceptual responses to submaximal and maximal treadmill exercise
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.
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological Response to ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Connie Tompkins, PhD, University of Vermont
- Investigators
- Connie Tompkins, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695785
- Sponsor's protocol ID
- M12-079
- Status last verified
- Sep 2015
- First submitted
- 24 Sep 2012
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Physical Exertion in Healthy Weight and Obese Adolescents: A Pilot Study
- ClinicalTrials.gov ID
- NCT01695785
- Acronym / sponsor ID
- M12-079
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy weight and obese adolescents from the community
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Perceptual responses to submaximal and maximal treadmill exercise
Time frame: 7-10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Tompkins, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physiological Response to Exercise and Perception of Exercise Difficulty, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological responses to submaximal and maximal treadmill exercise (time frame: 7-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2015.