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Effect of Exercise and Diet on Inflammation in Hypertensive Individuals

7 juni 2012 bijgewerkt door: Paul J. Mills, University of California, San Diego

Sympathetic Nervous System Regulation of Cell Adhesion

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.

Studie Overzicht

Gedetailleerde beschrijving

Hypertension is characterized by high blood pressure, as well as by inflammation and increased adhesion among blood cells. Inflammation may play an important role in atherosclerosis, which involves the build up of fatty deposits on the inside wall of arteries. Pharmacological treatment for hypertension successfully reduces blood pressure. However, it has limited effectiveness for reducing the associated inflammation. Losing weight and increasing physical activity have been shown to reduce general inflammation, but more research is needed to determine their effect on inflammation that is directly related to hypertension. The purpose of this study is to evaluate the effectiveness of an exercise program versus a combined exercise and diet program at reducing inflammation and cell adhesion in hypertensive individuals.

This study will enroll inactive and overweight hypertensive individuals. Participants will be randomly assigned to a 12-week exercise program, a 12-week combined exercise and diet program, or a non-intervention group. At study entry, participants will take part in a speech stressor task, a VO2 peak exercise test, and an exercise treadmill test. During the speech stressor task, participants will be videotaped while they talk about potentially stressful situations. Prior to and following the speech task, blood will be collected, blood pressure and heart rate will be recorded, and standardized questionnaires will be completed to assess anger, anxiety, and stress levels. The two exercise tests will occur within 5 days of each other and both will involve running on a treadmill. Heart rate, respiratory rate, and physical activity intensity will be monitored; heart activity will be measured by an electrocardiogram (ECG). Blood will be collected at various times during the testing procedures to measure levels of inflammation biomarkers, including C-reactive protein (CRP) and white blood cells. Perceived exertion and stress levels will also be assessed.

Participants in the exercise intervention 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. Participants in the diet program will meet with a dietician and will be encouraged to reduce their caloric intake by incorporating low-fat, high-fiber foods into their diet. Throughout the study, participants will have regular follow-up phone calls with study staff and meetings with their personal trainer and/or dietician to ensure that they are adhering to their assigned program. At the end of 12 weeks, participants will return for a repeat speech stressor task, a VO2 peak exercise test, and an exercise treadmill test. Participants in the non-intervention group will then be assigned to either the exercise program or combined exercise and diet program.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

185

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • California
      • San Diego, California, Verenigde Staten, 92103
        • University of California, San Diego

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

25 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of kidney damage
  • Current participation in regular or structured exercise classes, or regular physical exercise in the 6 months prior to study entry
  • Inability to perform moderate to vigorous intensity exercise
  • Current participation in a diet
  • High blood pressure, only when measured in a doctor's office (i.e., "white coat hypertension")
  • Arthritis, exertional asthma, or any other disorder likely to be made worse by exercise
  • Pregnant

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 1
12-week exercise program
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.
Experimenteel: 2
12-week combined exercise and diet program
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.
Geen tussenkomst: 3
Non-intervention group

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
CRP
Tijdsspanne: Measured at 4 years
Measured at 4 years
Interleukin-6 (IL-6)
Tijdsspanne: Measured at 4 years
Measured at 4 years
Tumor necrosis factor-alpha (TNF-alpha)
Tijdsspanne: Measured at 4 years
Measured at 4 years
Soluble intercellular adhesion molecule-1 (sICAM-1)
Tijdsspanne: Measured at 4 years
Measured at 4 years
SE-selectin
Tijdsspanne: Measured at 4 years
Measured at 4 years
Leukocyte CD11a expression
Tijdsspanne: Measured at 4 years
Measured at 4 years
Leukocyte CD11b expression
Tijdsspanne: Measured at 4 years
Measured at 4 years
Leukocyte activation
Tijdsspanne: Measured at 4 years
Measured at 4 years
Peripheral blood mononuclear cell chemotaxis
Tijdsspanne: Measured at 4 years
Measured at 4 years

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Physical fitness
Tijdsspanne: Measured at 4 years
Measured at 4 years
Weight
Tijdsspanne: Measured at 4 years
Measured at 4 years
Blood pressure
Tijdsspanne: Measured at 4 years
Measured at 4 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Paul J. Mills, PhD, University of California, San Diego

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2006

Primaire voltooiing (Werkelijk)

1 april 2012

Studie voltooiing (Werkelijk)

1 april 2012

Studieregistratiedata

Eerst ingediend

16 juni 2006

Eerst ingediend dat voldeed aan de QC-criteria

16 juni 2006

Eerst geplaatst (Schatting)

20 juni 2006

Updates van studierecords

Laatste update geplaatst (Schatting)

8 juni 2012

Laatste update ingediend die voldeed aan QC-criteria

7 juni 2012

Laatst geverifieerd

1 juni 2012

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 380
  • R01HL057265 (Subsidie/contract van de Amerikaanse NIH)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Exercise Program

3
Abonneren