NCT00113061

Brief Summary

The purpose of this study is to determine the effect of exercise training on elevated C-reactive protein (CRP) concentrations, an indicator of inflammation, in initially inactive women and men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

July 29, 2016

Status Verified

December 1, 2007

First QC Date

June 3, 2005

Last Update Submit

July 28, 2016

Conditions

Cardiovascular DiseasesHeart DiseasesObesity

Keywords

Coronary Heart Disease Risk Reduction

Outcome Measures

Primary Outcomes (1)

  • Plasma CRP concentration (measured at Month 4)

Secondary Outcomes (1)

  • Changes in visceral adiposity, the cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), and heart rate variability (measured at Month 4)

Interventions

ExercisePROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physically inactive
  • C-reactive protein level at least 2.0 mg/L but less than 10.0 mg/L upon study entry
  • Body mass index between 18.5 kg/square meter and 40.0 kg/square meter as measured at study entry
  • Does not smoke
  • Total cholesterol at least 240 mg/dl with LDL-C at least 160 mg/dl OR LDL less than 190 mg/dl and Framingham less than 10%
  • Triglyceride levels no higher than 300 mg/dl
  • Fasting glucose level less than 126
  • Systolic blood pressure less than 140 mm Hg and/or diastolic blood pressure less than 90 mm Hg as measured at study entry
  • If taking an oral contraceptive, aspirin, ibuprofen, or other anti-inflammatory medications, must be on a stable dose for 6 months prior to study entry
  • If taking a cholesterol medication, including statins, blood pressure medication (including ace inhibitors), or multi-vitamins, must be on a stable dose for 2 months prior to study entry

You may not qualify if:

  • Using a beta blocker, hormone replacement therapy, or corticosteroids (except inhalers)
  • Any rheumatologic, orthopedic, neurological, or autoimmune diseases, or seizure disorder
  • Any significant cardiovascular disease or disorders including, but not limited to, stent or coronary artery bypass grafting
  • Cardiac dysrhythmias including, but not limited to, left bundle branch block, atrial fibrillation, pacemaker, or automatic implantable cardioverter defibrillator
  • Any surgery, broken bones, blood donation, or anaphylactic shock within 6 months of study entry
  • Any sprain or strain, removal of wisdom teeth, or use of antibiotics within 3 months of study entry
  • History of stroke or TIA
  • History of cancer within at least 5 years of study entry
  • Diabetes or glucose intolerance
  • Planning on participating in any other research trials during the next year
  • Currently pregnant
  • Planning to becoming pregnant during the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center, LSU System

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

  • Church TS, Earnest CP, Thompson AM, Priest EL, Rodarte RQ, Saunders T, Ross R, Blair SN. Exercise without weight loss does not reduce C-reactive protein: the INFLAME study. Med Sci Sports Exerc. 2010 Apr;42(4):708-16. doi: 10.1249/MSS.0b013e3181c03a43.

    PMID: 19952828DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Timothy S. Church

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 3, 2005

First Posted

June 6, 2005

Study Start

July 1, 2004

Study Completion

June 1, 2006

Last Updated

July 29, 2016

Record last verified: 2007-12

Locations

US(1)