NCT01903941

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
Last Updated

July 19, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

June 28, 2013

Last Update Submit

July 17, 2013

Conditions

Inflammation

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

  • C-reactive protein

    3 months

Study Arms (2)

Training

EXPERIMENTAL

Aerobic

Behavioral: Aerobic Exercise

Control

PLACEBO COMPARATOR

Not exercise

Behavioral: Only Counseling

Interventions

Aerobic ExerciseBEHAVIORAL
Training
Only CounselingBEHAVIORAL
Control

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- Incapacity to exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InflammationMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 28, 2013

First Posted

July 19, 2013

Study Start

December 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

July 19, 2013

Record last verified: 2013-07