Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk

Inflammation Clinical Trial

Official title:

Anti-inflammatory Effect of Aerobic Exercise in Individual With Increased Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903941
• Other study ID #: CRPExercise
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2013
• Last updated: July 17, 2013
• Start date: December 2006
• Est. completion date: April 2008

Study information

• Verified date: July 2013
• Source: Escola Bahiana de Medicina e Saude Publica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Aerobic physical activity attenuates systemic inflammatory activity in individuals with cardiovascular risk.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation

Intervention

Behavioral:
• Aerobic Exercise

• Only Counseling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Escola Bahiana de Medicina e Saude Publica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-reactive protein		3 months	No