Cardiovascular DiseasesNCT00113061
Effect of Exercise on Elevated C-reactive Protein Concentrations in Formerly Inactive Adults
A study testing Exercise in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of exercise training on elevated C-reactive protein (CRP) concentrations, an indicator of inflammation, in initially inactive women and men. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2006
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physically inactive
- C-reactive protein level at least 2.0 mg/L but less than 10.0 mg/L upon study entry
- Body mass index between 18.5 kg/square meter and 40.0 kg/square meter as measured at study entry
- Does not smoke
- Total cholesterol at least 240 mg/dl with LDL-C at least 160 mg/dl OR LDL less than 190 mg/dl and Framingham less than 10%
- Triglyceride levels no higher than 300 mg/dl
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- Fasting glucose level less than 126
- Systolic blood pressure less than 140 mm Hg and/or diastolic blood pressure less than 90 mm Hg as measured at study entry
- If taking an oral contraceptive, aspirin, ibuprofen, or other anti-inflammatory medications, must be on a stable dose for 6 months prior to study entry
- If taking a cholesterol medication, including statins, blood pressure medication (including ace inhibitors), or multi-vitamins, must be on a stable dose for 2 months prior to study entry
Who cannot join
- Using a beta blocker, hormone replacement therapy, or corticosteroids (except inhalers)
- Any rheumatologic, orthopedic, neurological, or autoimmune diseases, or seizure disorder
- Any significant cardiovascular disease or disorders including, but not limited to, stent or coronary artery bypass grafting
- Cardiac dysrhythmias including, but not limited to, left bundle branch block, atrial fibrillation, pacemaker, or automatic implantable cardioverter defibrillator
- Any surgery, broken bones, blood donation, or anaphylactic shock within 6 months of study entry
- Any sprain or strain, removal of wisdom teeth, or use of antibiotics within 3 months of study entry
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- History of stroke or TIA
- History of cancer within at least 5 years of study entry
- Diabetes or glucose intolerance
- Planning on participating in any other research trials during the next year
- Currently pregnant
- Planning to becoming pregnant during the next year
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center, LSU System
Baton Rouge, Louisiana, 70808
About this study
Official title: INFLAME: Inflammation and Exercise
The purpose of this study is to determine the effect of exercise training on elevated C-reactive protein (CRP) concentrations, an indicator of inflammation, in initially inactive women and men.
Read the detailed description
BACKGROUND:
CRP, a marker of systemic inflammation, has been reported to be an independent predictor of cardiovascular disease in both women and men. Recently published data from cross-sectional analyses showed that CRP is inversely related to cardiorespiratory fitness, and that this association is independent of body mass index. Regular exercise may affect CRP levels, and can possibly be used as a means of reducing elevated CRP levels. Though there are a number of studies focusing on related topics, there are no published reports from randomized clinical trials on the effect of exercise training alone on CRP levels.
DESIGN NARRATIVE:
An estimated 200 individuals will be randomly assigned to either a no exercise control group or an exercise group. Exercising individuals will participate in 3 or 4 training sessions each week for 4 months, and will progress to a total energy expenditure of 16 kcal [kg(-1), week(-1)], which is an exercise dose at the upper end of current public health recommendations for physical activity. The target exercise intensity will be 50-70% of baseline volume of oxygen consumed (V02 max). VO2 max is the maximal rate of oxygen consumption during exercise, and is a measurement of fitness. The primary outcome measure will be plasma CRP concentration. Secondary outcomes will be changes in variables that are potential mechanisms through which regular exercise might reduce CRP. These variables include visceral adiposity, the cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), and heart rate variability as a measure of autonomic balance. Although the primary outcome is CRP level, this study will also contribute significantly to the limited body of literature examining the effect of exercise on the variables of visceral adiposity, cytokines, and heart rate variability.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Being tested
- Exercise
- Keywords
- Coronary Heart Disease Risk Reduction
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma CRP concentration (measured at Month 4)
Secondary outcomes (1)
Changes in visceral adiposity, the cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), and heart rate variability (measured at Month 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2005 (estimated)
- Study startJul 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 162 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Timothy S. Church, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113061
- Sponsor's protocol ID
- 180
- Other IDs
- R01HL075442
- Status last verified
- Dec 2007
- First submitted
- 3 Jun 2005
- Last updated
- 29 Jul 2016
- Results posted
- No
Publications
Dorling JL, Apolzan JW, Thomas DM, Hochsmann C, Johannsen NM, Ross R, Church TS, Martin CK. Exercise-induced compensation and C-reactive protein change in adults with elevated C-reactive protein: analysis of a randomised controlled trial. Eur J Appl Physiol. 2026 Aug 27. doi: 10.1007/s00421-026-06405-4. Online ahead of print.
PubMed 42658215Church TS, Earnest CP, Thompson AM, Priest EL, Rodarte RQ, Saunders T, Ross R, Blair SN. Exercise without weight loss does not reduce C-reactive protein: the INFLAME study. Med Sci Sports Exerc. 2010 Apr;42(4):708-16. doi: 10.1249/MSS.0b013e3181c03a43.
PubMed 19952828
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFLAME: Inflammation and Exercise
- ClinicalTrials.gov ID
- NCT00113061
- Acronym / sponsor ID
- 180
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Keywords
- Coronary Heart Disease Risk Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 2004
- Study completion
- Jun 2006 (actual)
- First posted
- 6 Jun 2005 (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.
The purpose of this study is to determine the effect of exercise training on elevated C-reactive protein (CRP) concentrations, an indicator of inflammation, in initially inactive women and men.
Detailed description
BACKGROUND:
CRP, a marker of systemic inflammation, has been reported to be an independent predictor of cardiovascular disease in both women and men. Recently published data from cross-sectional analyses showed that CRP is inversely related to cardiorespiratory fitness, and that this association is independent of body mass index. Regular exercise may affect CRP levels, and can possibly be used as a means of reducing elevated CRP levels. Though there are a number of studies focusing on related topics, there are no published reports from randomized clinical trials on the effect of exercise training alone on CRP levels.
DESIGN NARRATIVE:
An estimated 200 individuals will be randomly assigned to either a no exercise control group or an exercise group. Exercising individuals will participate in 3 or 4 training sessions each week for 4 months, and will progress to a total energy expenditure of 16 kcal [kg(-1), week(-1)], which is an exercise dose at the upper end of current public health recommendations for physical activity. The target exercise intensity will be 50-70% of baseline volume of oxygen consumed (V02 max). VO2 max is the maximal rate of oxygen consumption during exercise, and is a measurement of fitness. The primary outcome measure will be plasma CRP concentration. Secondary outcomes will be changes in variables that are potential mechanisms through which regular exercise might reduce CRP. These variables include visceral adiposity, the cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), and heart rate variability as a measure of autonomic balance. Although the primary outcome is CRP level, this study will also contribute significantly to the limited body of literature examining the effect of exercise on the variables of visceral adiposity, cytokines, and heart rate variability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Physically inactive
- C-reactive protein level at least 2.0 mg/L but less than 10.0 mg/L upon study entry
- Body mass index between 18.5 kg/square meter and 40.0 kg/square meter as measured at study entry
- Does not smoke
- Total cholesterol at least 240 mg/dl with LDL-C at least 160 mg/dl OR LDL less than 190 mg/dl and Framingham less than 10%
Key exclusion criteria (12 listed)
- Using a beta blocker, hormone replacement therapy, or corticosteroids (except inhalers)
- Any rheumatologic, orthopedic, neurological, or autoimmune diseases, or seizure disorder
- Any significant cardiovascular disease or disorders including, but not limited to, stent or coronary artery bypass grafting
- Cardiac dysrhythmias including, but not limited to, left bundle branch block, atrial fibrillation, pacemaker, or automatic implantable cardioverter defibrillator
- Any surgery, broken bones, blood donation, or anaphylactic shock within 6 months of study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise | Procedure or surgery | – |
Primary outcome
Plasma CRP concentration (measured at Month 4)
1 secondary outcome
Changes in visceral adiposity, the cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), and heart rate variability (measured at Month 4)
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 29 Jul 2016.
- Derived from this study: PubMed 42658215Dorling JL, Apolzan JW, Thomas DM, Hochsmann C, Johannsen NM, Ross R, Church TS, Martin CK. Exercise-induced compensation and C-reactive protein change in adults with elevated C-reactive protein: analysis of a randomised controlled trial. Eur J Appl Physiol. 2026 Aug 27. doi: 10.1007/s00421-026-06405-4. Online ahead of print.
- Derived from this study: PubMed 19952828Church TS, Earnest CP, Thompson AM, Priest EL, Rodarte RQ, Saunders T, Ross R, Blair SN. Exercise without weight loss does not reduce C-reactive protein: the INFLAME study. Med Sci Sports Exerc. 2010 Apr;42(4):708-16. doi: 10.1249/MSS.0b013e3181c03a43.
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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.
Timothy S. Church principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) 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 10 inclusion and 12 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: finished, as of the sponsor's last update on 29 Jul 2016. 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?
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.
What does the primary outcome measure?
Plasma CRP concentration (measured at Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00113061, which also lists 2 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 29 Jul 2016.