InflammationPhase 2NCT01903941
Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk
A Phase 2 study testing Aerobic Exercise and Only Counseling in people with Inflammation, run by Escola Bahiana de Medicina e Saude Publica.
Trial summary
Aerobic physical activity attenuates systemic inflammatory activity in individuals with cardiovascular risk. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Inflammation
- What is being tested?
- Aerobic Exercise and Only Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Apr 2008
- Phase
- Phase 2
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with are between 40 to 70 years, no regular exercise, and at least two risk factor for cardiovascular disease (diabetes, hypertension, dyslipidemia, smoking) or documented cardiovascular disease.
Who cannot join
- Incapacity to exercise.
About this study
Aerobic physical activity attenuates systemic inflammatory activity in individuals with cardiovascular risk.
Read the detailed description
Background: Observational studies suggest that exercise has anti-inflammatory effect, however this idea has not been definitively confirmed by randomized clinical trials.
Objective: To test the hypothesis that aerobic exercise attenuates systemic inflammatory activity in individuals with cardiovascular risk.
Methods: Randomized controlled trial, which included 68 sedentary individuals, with at least two risk factors for coronary heart disease or established cardiovascular disease. The volunteers were randomized to 3 months of supervised aerobic training or just advice when healthy lifestyles. C-reactive protein (CRP) was measured by the method of high sensitivity before and after 3 months of intervention.
- Conditions
- Inflammation
- Being tested
- Aerobic Exercise, Only Counseling
- Keywords
- exercise
- Medical subject headings
- Inflammation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Only CounselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Aerobic Receives: Behavioral: Aerobic Exercise |
| Control | Placebo comparator | Not exercise Receives: Behavioral: Only Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startDec 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Bahiana de Medicina e Saude Publica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis CL Correia, Escola Bahiana de Medicina e Saude Publica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903941
- Sponsor's protocol ID
- CRPExercise
- Status last verified
- Jul 2013
- First submitted
- 28 Jun 2013
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT01903941
- Acronym / sponsor ID
- CRPExercise
- Conditions
- Inflammation
- Keywords
- exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Escola Bahiana de Medicina e Saude PublicaUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 19 Jul 2013 (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.
Aerobic physical activity attenuates systemic inflammatory activity in individuals with cardiovascular risk.
Detailed description
Background: Observational studies suggest that exercise has anti-inflammatory effect, however this idea has not been definitively confirmed by randomized clinical trials.
Objective: To test the hypothesis that aerobic exercise attenuates systemic inflammatory activity in individuals with cardiovascular risk.
Methods: Randomized controlled trial, which included 68 sedentary individuals, with at least two risk factors for coronary heart disease or established cardiovascular disease. The volunteers were randomized to 3 months of supervised aerobic training or just advice when healthy lifestyles. C-reactive protein (CRP) was measured by the method of high sensitivity before and after 3 months of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Aerobic ExerciseAerobic |
| Control | Placebo comparator | Behavioral: Only CounselingNot exercise |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with are between 40 to 70 years, no regular exercise, and at least two risk factor for cardiovascular disease (diabetes, hypertension, dyslipidemia, smoking) or documented cardiovascular disease.
Key exclusion criteria (1 listed)
- Incapacity to exercise.
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 |
|---|---|---|
| Aerobic Exercise | Behavioural | Training |
| Only Counseling | Behavioural | Control |
Primary outcome
C-reactive protein
Time frame: 3 months
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 19 Jul 2013.
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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?
A Phase 2 study testing Aerobic Exercise and Only Counseling in people with Inflammation, run by Escola Bahiana de Medicina e Saude Publica.
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 1 inclusion and 1 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 19 Jul 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
C-reactive protein (time frame: 3 months). 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 19 Jul 2013.