- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01903941
Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Incapacity to exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training
Aerobic
|
|
Placebo Comparator: Control
Not exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
C-reactive protein
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRPExercise
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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