NCT00338572

Brief Summary

In addition to high blood pressure, hypertension is characterized by inflammation, which is the body's response to injury or infection. Inflammation has been found to cause plaque formation on artery walls. This study will compare the effect of an exercise program versus a combined exercise and diet program on reducing inflammation in hypertensive individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable hypertension

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

Enrollment Period

5.8 years

First QC Date

June 16, 2006

Last Update Submit

June 7, 2012

Conditions

Hypertension

Keywords

InflammationBlood Pressure, High

Outcome Measures

Primary Outcomes (9)

  • CRP

    Measured at 4 years

  • Interleukin-6 (IL-6)

    Measured at 4 years

  • Tumor necrosis factor-alpha (TNF-alpha)

    Measured at 4 years

  • Soluble intercellular adhesion molecule-1 (sICAM-1)

    Measured at 4 years

  • SE-selectin

    Measured at 4 years

  • Leukocyte CD11a expression

    Measured at 4 years

  • Leukocyte CD11b expression

    Measured at 4 years

  • Leukocyte activation

    Measured at 4 years

  • Peripheral blood mononuclear cell chemotaxis

    Measured at 4 years

Secondary Outcomes (3)

  • Physical fitness

    Measured at 4 years

  • Weight

    Measured at 4 years

  • Blood pressure

    Measured at 4 years

Study Arms (3)

1

ACTIVE COMPARATOR

12-week exercise program

Behavioral: Exercise Program

2

EXPERIMENTAL

12-week combined exercise and diet program

Behavioral: Combined Exercise and Diet Program

3

NO INTERVENTION

Non-intervention group

Interventions

Exercise ProgramBEHAVIORAL

Participants in the exercise group will receive a 12-week membership to the YMCA and will meet with a personal trainer twice a week. They will be encouraged to exercise on their own for an additional 3 to 4 days per week. Participants will also be provided with a pedometer, which will track the number of steps they take each day.

1
Combined Exercise and Diet ProgramBEHAVIORAL

Participants in this group will receive a 12-week membership to the YMCA and will meet with a personal trainer twice a week. They will be encouraged to exercise on their own for an additional 3 to 4 days per week. Participants will also be provided with a pedometer, which will track the number of steps they take each day. They will meet with a dietician and will be encouraged to reduce their caloric intake by incorporating low-fat, high-fiber foods into their diet.

2

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unmedicated hypertension with blood pressure greater than 140/90 mm Hg but less than 175/104 mm Hg
  • Body mass index (BMI) of 23.5 to 34
  • Relatively inactive, as defined by the Leisure Time Exercise Questionnaire
  • Willing and able to participate in the assigned study group
  • Postmenopausal women not on hormone replacement therapy (HRT) and premenopausal women

You may not qualify if:

  • Abnormal echocardiogram
  • Recent stroke or significant brain impairment
  • Current psychiatric disease
  • History of psychosis or major depression
  • Currently taking psychotropic drugs
  • Currently taking any medications (e.g., anti-inflammatory medications) other than antihypertensives (which will be tapered)
  • Current drug and/or alcohol abuse
  • Consumes more than 600 mg of caffeine per day
  • Diabetes
  • Congestive heart failure
  • Bronchospastic pulmonary disease
  • History of heart attacks
  • Known secondary high blood pressure
  • Angina
  • History of life-threatening arrhythmias
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

HypertensionInflammation

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Paul J. Mills, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

June 1, 2006

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

June 8, 2012

Record last verified: 2012-06

Locations

US(1)