Cardiovascular DiseasesNCT00005521
Exercise and Blood Pressure in Children: A Meta-Analysis
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To use the meta-analytic approach to examine the effects of aerobic exercise on resting systolic and diastolic blood pressure in children. 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
- Jun 1998to Jul 2004
- 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 use the meta-analytic approach to examine the effects of aerobic exercise on resting systolic and diastolic blood pressure in children.
Read the detailed description
BACKGROUND:
Approximately 50 million Americans suffer from hypertension, a condition associated with increased risk for stroke, heart attack, and kidney failure. While non-pharmacological intervention has resulted in dramatic reductions in resting systolic and diastolic blood pressure for those with elevated pressures, a debate continues over the efficacy of pharmacological intervention because of deleterious side effects. As a result, there has been an increased interest in aerobic exercise as a non-pharmacologic approach in treating hypertension. Recent reviews of literature have synthesized research using the 'traditional' approach (chronologically arranging and describing the studies, perhaps by sub-topic) which may result in subjective, non-replicable conclusions. Consequently, the relationships among such variables as subject characteristics, experimental design quality, training program characteristics, and how they contribute to changes in resting systolic and diastolic blood pressure is not clear.
The meta-analytic approach is used in the study to synthesize research on the relationships among variables associated with aerobic exercise intervention and resting systolic and diastolic blood pressure in adults. Meta-analysis is a method of pooling the results of separate studies. It is a quantitative approach for increasing statistical power of primary end points and subgroups, resolving uncertainty when studies disagree, improving estimates of effect sizes, and answering questions not posed at the start of individual trials.
DESIGN NARRATIVE:
In the first two years of the study, a meta-analysis was conducted of all studies published since 1966 on aerobic exercise and blood pressure. The study was renewed in FY 2000 to conduct meta-analysis of all studies of exercise training in children and youth under age 21 years in which resting BP was measured. This will include both randomized and non-randomized clinical trials of at least eight weeks duration found in English journals and theses between 1966 and 1999. Standard meta-analysis techniques will be applied.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
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 startJun 1998
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- George Kelley, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005521
- Sponsor's protocol ID
- 5048
- Other IDs
- R01HL056893
- Status last verified
- Dec 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Kelley GA, Kelley KS. Aerobic exercise and resting blood pressure in women: a meta-analytic review of controlled clinical trials. J Womens Health Gend Based Med. 1999 Jul-Aug;8(6):787-803. doi: 10.1089/152460999319110.
PubMed 10495260Kelley GA, Kelley KS, Tran ZV. Walking and resting blood pressure in adults: a meta-analysis. Prev Med. 2001 Aug;33(2 Pt 1):120-7. doi: 10.1006/pmed.2001.0860.
PubMed 11493045Kelley GA, Sharpe Kelley K. Aerobic exercise and resting blood pressure in older adults: a meta-analytic review of randomized controlled trials. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):M298-303. doi: 10.1093/gerona/56.5.m298.
PubMed 11320110Kelley GA, Kelley KS, Tran ZV. The effects of exercise on resting blood pressure in children and adolescents: a meta-analysis of randomized controlled trials. Prev Cardiol. 2003 Winter;6(1):8-16. doi: 10.1111/j.1520-037x.2003.01224.x.
PubMed 12624556
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Blood Pressure in Children: A Meta-Analysis
- ClinicalTrials.gov ID
- NCT00005521
- Acronym / sponsor ID
- 5048
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jun 1998
- Study completion
- Jul 2004 (actual)
- 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 use the meta-analytic approach to examine the effects of aerobic exercise on resting systolic and diastolic blood pressure in children.
Detailed description
BACKGROUND:
Approximately 50 million Americans suffer from hypertension, a condition associated with increased risk for stroke, heart attack, and kidney failure. While non-pharmacological intervention has resulted in dramatic reductions in resting systolic and diastolic blood pressure for those with elevated pressures, a debate continues over the efficacy of pharmacological intervention because of deleterious side effects. As a result, there has been an increased interest in aerobic exercise as a non-pharmacologic approach in treating hypertension. Recent reviews of literature have synthesized research using the 'traditional' approach (chronologically arranging and describing the studies, perhaps by sub-topic) which may result in subjective, non-replicable conclusions. Consequently, the relationships among such variables as subject characteristics, experimental design quality, training program characteristics, and how they contribute to changes in resting systolic and diastolic blood pressure is not clear.
The meta-analytic approach is used in the study to synthesize research on the relationships among variables associated with aerobic exercise intervention and resting systolic and diastolic blood pressure in adults. Meta-analysis is a method of pooling the results of separate studies. It is a quantitative approach for increasing statistical power of primary end points and subgroups, resolving uncertainty when studies disagree, improving estimates of effect sizes, and answering questions not posed at the start of individual trials.
DESIGN NARRATIVE:
In the first two years of the study, a meta-analysis was conducted of all studies published since 1966 on aerobic exercise and blood pressure. The study was renewed in FY 2000 to conduct meta-analysis of all studies of exercise training in children and youth under age 21 years in which resting BP was measured. This will include both randomized and non-randomized clinical trials of at least eight weeks duration found in English journals and theses between 1966 and 1999. Standard meta-analysis techniques will be applied.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
- Time perspective
- Retrospective
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 13 May 2016.
- Background: PubMed 10495260Kelley GA, Kelley KS. Aerobic exercise and resting blood pressure in women: a meta-analytic review of controlled clinical trials. J Womens Health Gend Based Med. 1999 Jul-Aug;8(6):787-803. doi: 10.1089/152460999319110.
- Background: PubMed 11493045Kelley GA, Kelley KS, Tran ZV. Walking and resting blood pressure in adults: a meta-analysis. Prev Med. 2001 Aug;33(2 Pt 1):120-7. doi: 10.1006/pmed.2001.0860.
- Background: PubMed 11320110Kelley GA, Sharpe Kelley K. Aerobic exercise and resting blood pressure in older adults: a meta-analytic review of randomized controlled trials. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):M298-303. doi: 10.1093/gerona/56.5.m298.
- Background: PubMed 12624556Kelley GA, Kelley KS, Tran ZV. The effects of exercise on resting blood pressure in children and adolescents: a meta-analysis of randomized controlled trials. Prev Cardiol. 2003 Winter;6(1):8-16. doi: 10.1111/j.1520-037x.2003.01224.x.
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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.
George Kelley
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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 13 May 2016. 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 NCT00005521, which also lists 4 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 13 May 2016.