Resistant Hypertension
Conditions
Keywords
Exercise training, Ambulatory blood pressure, Resistant Hypertension, Nitric Oxide
Brief summary
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.
Interventions
OTHERExercise Group
The 12-week exercise-training program will include three sessions of aerobic exercise per week
Sponsors
University Institute of Maia
Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga
Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos
Cintesis & Departamento de Medicina da Faculdade de Medicina do Porto
Aveiro University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
confirmed resistant hypertension, who in the previous 3 months had unchanged medication
Exclusion criteria
1. Patients with secondary hypertension 2. Evidence of target organ damage 3. Patients with heart failure 4. Previous cardiovascular event 5. Peripheral artery disease 6. Renal failure 7. Chronic obstructive pulmonary disease 8. Systolic office blood pressure superior to 180 mmHg 9. Biomechanical limitations to physical activity 10. Those participating in regular physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory blood pressure | Change from Baseline in Blood Pressure at 3 months | Blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | Change from baseline to 3 months | Body composition |
| Health-related quality of life | Change from baseline to 3 months | Health-related quality of life will be evaluated by the Short-Form 36. |
| Arterial stiffness | Change from baseline to 3 months | Carotid-femoral pulse wave velocity, central pressures and aortic augmentation index and augmentation pressure. |
| Heart rate variability | Change from baseline to 3 months | Recordings of R-R interval data; The R-R interval will be analyzed using time domain, frequency domain and Poincare´ plot techniques. |
| Circulating number of endothelial progenitor cells, circulating endothelial cells, nitric oxide and endothelial Nitric Oxide Synthase | Change from baseline to 3 months | These markers will inform endothelial function, damage and repair |
| Casual blood pressure | Change from baseline to 3 months | Blood pressure |
| Oxidative stress | Change from baseline to 3 months | Plasma levels of oxidative stress and antioxidant markers. |
| Daily physical activity | Change from baseline to 3 months | Physical activity will be measured during 7 consecutive days using an accelerometer. |
| Dietary intake | Change from baseline to 3 months | Dietary intake will be assessed using a 4-day food diary. |
| VO2 max | Change from baseline to 3 months | VO2 max will be determined by the Chester step test. |
| Inflammation | Change from baseline to 3 months | Plasma levels of inflammatory and anti-inflammatory biomarkers. |
Countries
Portugal
Outcome results
None listed