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Effect of Exercise and Diet on Inflammation in Hypertensive Individuals

7 juin 2012 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

185

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • California
      • San Diego, California, États-Unis, 92103
        • University of California, San Diego

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

25 ans à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Expérimental: 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.
Aucune intervention: 3
Non-intervention group

Que mesure l'étude ?

Principaux critères de jugement

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

Mesures de résultats secondaires

Mesure des résultats
Délai
Physical fitness
Délai: Measured at 4 years
Measured at 4 years
Weight
Délai: Measured at 4 years
Measured at 4 years
Blood pressure
Délai: Measured at 4 years
Measured at 4 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2006

Achèvement primaire (Réel)

1 avril 2012

Achèvement de l'étude (Réel)

1 avril 2012

Dates d'inscription aux études

Première soumission

16 juin 2006

Première soumission répondant aux critères de contrôle qualité

16 juin 2006

Première publication (Estimation)

20 juin 2006

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

8 juin 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 juin 2012

Dernière vérification

1 juin 2012

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 380
  • R01HL057265 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Hypertension

Essais cliniques sur Exercise Program

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