The Role of Exercise Training in the Treatment of Resistant Hypertension

Study Overview
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Brief Summary
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The main purpose of this study is to assess whether exercise training reduces ambulatory blood pressure in patients with resistant hypertension. To accomplish these goals 60 patients with resistant hypertension will be recruited and randomized into exercise training or control groups and followed up for 6 months. The patients in the exercise group will participate in a 3-month outpatient program. The control group will receive usual medical care. At baseline, after the intervention and 3 months after the end of the intervention both groups will undergo several evaluations, including casual and ambulatory blood pressure, body composition, cardiorespiratory fitness, quality of life, arterial stiffness, autonomic function, and endothelial and inflammatory biomarkers.

Official Title
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The Role of Exercise Training in the Treatment of Resistant Hypertension

Conditions
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Resistant Hypertension

Intervention / Treatment
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* Other: Exercise Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed resistant hypertension, who in the previous 3 months had unchanged medication Exclusion Criteria: Patients with secondary hypertension Evidence of target organ damage Patients with heart failure Previous cardiovascular event Peripheral artery disease Renal failure Chronic obstructive pulmonary disease Systolic office blood pressure superior to 180 mmHg Biomechanical limitations to physical activity Those participating in regular physical activity

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>The 12-week exercise-training program will include three sessions of aerobic exercise per week | Other: Exercise Group<br>* The 12-week exercise-training program will include three sessions of aerobic exercise per week<br>|
| No Intervention: Control group<br>The control group will receive usual medical care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure | Blood pressure | Change from Baseline in Blood Pressure at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Casual blood pressure | Blood pressure | Change from baseline to 3 months | 
| Body composition | Body composition | Change from baseline to 3 months | 
| Health-related quality of life | Health-related quality of life will be evaluated by the Short-Form 36. | Change from baseline to 3 months | 
| Arterial stiffness | Carotid-femoral pulse wave velocity, central pressures and aortic augmentation index and augmentation pressure. | Change from baseline to 3 months | 
| Heart rate variability | Recordings of R-R interval data; The R-R interval will be analyzed using time domain, frequency domain and Poincare´ plot techniques. | Change from baseline to 3 months | 
| Circulating number of endothelial progenitor cells, circulating endothelial cells, nitric oxide and endothelial Nitric Oxide Synthase | These markers will inform endothelial function, damage and repair | Change from baseline to 3 months | 
| Inflammation | Plasma levels of inflammatory and anti-inflammatory biomarkers. | Change from baseline to 3 months | 
| Oxidative stress | Plasma levels of oxidative stress and antioxidant markers. | Change from baseline to 3 months | 
| Daily physical activity | Physical activity will be measured during 7 consecutive days using an accelerometer. | Change from baseline to 3 months | 
| Dietary intake | Dietary intake will be assessed using a 4-day food diary. | Change from baseline to 3 months | 
| VO2 max | VO2 max will be determined by the Chester step test. | Change from baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise training, Ambulatory blood pressure, Resistant Hypertension, Nitric Oxide