- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00338572
Effect of Exercise and Diet on Inflammation in Hypertensive Individuals
Sympathetic Nervous System Regulation of Cell Adhesion
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
San Diego, California, Förenta staterna, 92103
- University of California, San Diego
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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.
|
Experimentell: 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.
|
Inget ingripande: 3
Non-intervention group
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
CRP
Tidsram: Measured at 4 years
|
Measured at 4 years
|
Interleukin-6 (IL-6)
Tidsram: Measured at 4 years
|
Measured at 4 years
|
Tumor necrosis factor-alpha (TNF-alpha)
Tidsram: Measured at 4 years
|
Measured at 4 years
|
Soluble intercellular adhesion molecule-1 (sICAM-1)
Tidsram: Measured at 4 years
|
Measured at 4 years
|
SE-selectin
Tidsram: Measured at 4 years
|
Measured at 4 years
|
Leukocyte CD11a expression
Tidsram: Measured at 4 years
|
Measured at 4 years
|
Leukocyte CD11b expression
Tidsram: Measured at 4 years
|
Measured at 4 years
|
Leukocyte activation
Tidsram: Measured at 4 years
|
Measured at 4 years
|
Peripheral blood mononuclear cell chemotaxis
Tidsram: Measured at 4 years
|
Measured at 4 years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Physical fitness
Tidsram: Measured at 4 years
|
Measured at 4 years
|
Weight
Tidsram: Measured at 4 years
|
Measured at 4 years
|
Blood pressure
Tidsram: Measured at 4 years
|
Measured at 4 years
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Paul J. Mills, PhD, University of California, San Diego
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 380
- R01HL057265 (U.S.S. NIH-anslag/kontrakt)
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