Anti-inflammatory Effect of Aerobic Exercise in Individua... | NCT01903941

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

NCT01903941

Sponsor

Escola Bahiana de Medicina e Saude Publica

Status

Completed

Last Update Posted

Jul 19, 2013Estimated

Enrollment

68Actual

Phase

Phase 2

Conditions

Inflammation

Interventions

Aerobic Exercise
Only Counseling

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jun 28, 2013

First Submission Date that Met QC Criteria

Jul 17, 2013

First Posted Date

Jul 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2013

Last Update Posted Date

Jul 19, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luis CL Correia, Associate Professor of Medicine, Escola Bahiana de Medicina e Saude PublicaPrincipal Investigator

Lead Sponsor

Escola Bahiana de Medicina e Saude PublicaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training	Experimental	Aerobic	Behavioral: Aerobic Exercise
Control	Placebo Comparator	Not exercise	Behavioral: Only Counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aerobic Exercise	Behavioral		Training
Only Counseling

Measure	Description	Time Frame
C-reactive protein		3 months

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation
D009043	Motor Activity

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided