Cardiovascular DiseasesNCT00005695
Physical Training and Blood Pressure in High Risk Youths
An observational study of Cardiovascular Diseases and Heart Diseases, run by Augusta University.
Trial summary
To determine the effects of physical activity on blood pressure and body fat in children varying in ethnicity, gender, and health status. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1995to Dec 1997
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the effects of physical activity on blood pressure and body fat in children varying in ethnicity, gender, and health status.
Read the detailed description
DESIGN NARRATIVE:
There were two specific aims. The first was to test the hypothesis that controlled physical training (PT) reduced blood pressure, at rest and in reaction to forehead cold and exercise stressors, in 8-9 year olds who were high in both blood pressure and body fatness. Subjects were divided equally on gender and blood pressure and body fatness. Subjects were divided equally on gender and ethnicity (black/white). Both resting and reactive blood pressure were correlated with left ventricular mass and were predictive of future essential hypertension. The underlying hemodynamic regulators of blood pressure, cardiac output and the total peripheral resistance, were measured with impedance cardiography to explore hemodynamic mechanisms through which training had a favorable influence on blood pressure and left ventricular mass.
The second aim tested the hypothesis that physical training reduced percent body fat, as measured with dual energy x-ray absorptiometry (DEXA). Children above the 70th percentile in both blood pressure and fatness were randomly assigned, within ethnicity and gender, to a physical training or waiting list control group. After the physical training group underwent four months of training, all subjects were retested and these data were used to test the primary hypotheses. The initial control subjects then performed four months of physical training, after which they were retested. The data from this second phase were added to the data of the initial physical training group to explore interactions of training with gender and ethnicity. The initial physical training group was brought back four months after cessation of training to see if the changes elicited by the training were reversible. To document the stimulation provided by the training, heart rate was monitored during training sessions. To observe the time course of changes between the full lab testing sessions, skinfolds and resting blood pressure were measured monthly. Diet and free living physical activity were assessed to help explain changes in body composition. Aerobic fitness was measured with treadmill tests of maximal oxygen consumption.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJan 1995
- Study completionDec 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005695
- Sponsor's protocol ID
- 4258
- Other IDs
- R01HL049549
- Status last verified
- Apr 2002
- First submitted
- 25 May 2000
- Last updated
- 23 Dec 2015
- Results posted
- No
Publications
Gutin B, Owens S, Slavens G, Riggs S, Treiber F. Effect of physical training on heart-period variability in obese children. J Pediatr. 1997 Jun;130(6):938-43. doi: 10.1016/s0022-3476(97)70280-4.
PubMed 9202616Gutin B, Owens S, Treiber F, Islam S, Karp W, Slavens G. Weight-independent cardiovascular fitness and coronary risk factors. Arch Pediatr Adolesc Med. 1997 May;151(5):462-5. doi: 10.1001/archpedi.1997.02170420032005.
PubMed 9158437Gutin B, Litaker M, Islam S, Manos T, Smith C, Treiber F. Body-composition measurement in 9-11-y-old children by dual-energy X-ray absorptiometry, skinfold-thickness measurements, and bioimpedance analysis. Am J Clin Nutr. 1996 Mar;63(3):287-92. doi: 10.1093/ajcn/63.3.287.
PubMed 8602582Gutin B, Barbeau P, Litaker MS, Ferguson M, Owens S. Heart rate variability in obese children: relations to total body and visceral adiposity, and changes with physical training and detraining. Obes Res. 2000 Jan;8(1):12-9. doi: 10.1038/oby.2000.3.
PubMed 10678254Owens S, Litaker M, Allison J, Riggs S, Ferguson M, Gutin B. Prediction of visceral adipose tissue from simple anthropometric measurements in youths with obesity. Obes Res. 1999 Jan;7(1):16-22. doi: 10.1002/j.1550-8528.1999.tb00386.x.
PubMed 10023726Owens S, Gutin B, Allison J, Riggs S, Ferguson M, Litaker M, Thompson W. Effect of physical training on total and visceral fat in obese children. Med Sci Sports Exerc. 1999 Jan;31(1):143-8. doi: 10.1097/00005768-199901000-00022.
PubMed 9927022
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Training and Blood Pressure in High Risk Youths
- ClinicalTrials.gov ID
- NCT00005695
- Acronym / sponsor ID
- 4258
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 1995
- Study completion
- Dec 1997
- First posted
- 26 May 2000 (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.
To determine the effects of physical activity on blood pressure and body fat in children varying in ethnicity, gender, and health status.
Detailed description
DESIGN NARRATIVE:
There were two specific aims. The first was to test the hypothesis that controlled physical training (PT) reduced blood pressure, at rest and in reaction to forehead cold and exercise stressors, in 8-9 year olds who were high in both blood pressure and body fatness. Subjects were divided equally on gender and blood pressure and body fatness. Subjects were divided equally on gender and ethnicity (black/white). Both resting and reactive blood pressure were correlated with left ventricular mass and were predictive of future essential hypertension. The underlying hemodynamic regulators of blood pressure, cardiac output and the total peripheral resistance, were measured with impedance cardiography to explore hemodynamic mechanisms through which training had a favorable influence on blood pressure and left ventricular mass.
The second aim tested the hypothesis that physical training reduced percent body fat, as measured with dual energy x-ray absorptiometry (DEXA). Children above the 70th percentile in both blood pressure and fatness were randomly assigned, within ethnicity and gender, to a physical training or waiting list control group. After the physical training group underwent four months of training, all subjects were retested and these data were used to test the primary hypotheses. The initial control subjects then performed four months of physical training, after which they were retested. The data from this second phase were added to the data of the initial physical training group to explore interactions of training with gender and ethnicity. The initial physical training group was brought back four months after cessation of training to see if the changes elicited by the training were reversible. To document the stimulation provided by the training, heart rate was monitored during training sessions. To observe the time course of changes between the full lab testing sessions, skinfolds and resting blood pressure were measured monthly. Diet and free living physical activity were assessed to help explain changes in body composition. Aerobic fitness was measured with treadmill tests of maximal oxygen consumption.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Background: PubMed 9202616Gutin B, Owens S, Slavens G, Riggs S, Treiber F. Effect of physical training on heart-period variability in obese children. J Pediatr. 1997 Jun;130(6):938-43. doi: 10.1016/s0022-3476(97)70280-4.
- Background: PubMed 9158437Gutin B, Owens S, Treiber F, Islam S, Karp W, Slavens G. Weight-independent cardiovascular fitness and coronary risk factors. Arch Pediatr Adolesc Med. 1997 May;151(5):462-5. doi: 10.1001/archpedi.1997.02170420032005.
- Background: PubMed 8602582Gutin B, Litaker M, Islam S, Manos T, Smith C, Treiber F. Body-composition measurement in 9-11-y-old children by dual-energy X-ray absorptiometry, skinfold-thickness measurements, and bioimpedance analysis. Am J Clin Nutr. 1996 Mar;63(3):287-92. doi: 10.1093/ajcn/63.3.287.
- Background: PubMed 10678254Gutin B, Barbeau P, Litaker MS, Ferguson M, Owens S. Heart rate variability in obese children: relations to total body and visceral adiposity, and changes with physical training and detraining. Obes Res. 2000 Jan;8(1):12-9. doi: 10.1038/oby.2000.3.
- Background: PubMed 10023726Owens S, Litaker M, Allison J, Riggs S, Ferguson M, Gutin B. Prediction of visceral adipose tissue from simple anthropometric measurements in youths with obesity. Obes Res. 1999 Jan;7(1):16-22. doi: 10.1002/j.1550-8528.1999.tb00386.x.
- Background: PubMed 9927022Owens S, Gutin B, Allison J, Riggs S, Ferguson M, Litaker M, Thompson W. Effect of physical training on total and visceral fat in obese children. Med Sci Sports Exerc. 1999 Jan;31(1):143-8. doi: 10.1097/00005768-199901000-00022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Augusta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005695, which also lists 6 linked publications.
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 23 Dec 2015.