Back to resultsAnti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk
Primary Purpose
Inflammation
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Aerobic Exercise
Only Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring exercise
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Training
Control
Arm Description
Aerobic
Not exercise
Outcomes
Primary Outcome Measures
C-reactive protein
Secondary Outcome Measures
Full Information
NCT ID
NCT01903941
First Posted
June 28, 2013
Last Updated
July 17, 2013
Sponsor
Escola Bahiana de Medicina e Saude Publica
1. Study Identification
Unique Protocol Identification Number
NCT01903941
Brief Title
Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk
Official Title
Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Bahiana de Medicina e Saude Publica
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Experimental
Arm Description
Aerobic
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Not exercise
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Type
Behavioral
Intervention Name(s)
Only Counseling
Primary Outcome Measure Information:
Title
C-reactive protein
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk
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