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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03090529
Other study ID # 1725/2014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2017
Est. completion date March 30, 2020

Study information

Verified date December 2020
Source Aveiro University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 30, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise Group
The 12-week exercise-training program will include three sessions of aerobic exercise per week

Locations

Country Name City State
Portugal Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga Aveiro
Portugal Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos Matosinhos

Sponsors (5)

Lead Sponsor Collaborator
Aveiro University Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga, Cintesis & Departamento de Medicina da Faculdade de Medicina do Porto, Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos, University Institute of Maia

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ambulatory blood pressure Blood pressure Change from Baseline in Blood Pressure at 3 months
Secondary Casual blood pressure Blood pressure Change from baseline to 3 months
Secondary Body composition Body composition Change from baseline to 3 months
Secondary Health-related quality of life Health-related quality of life will be evaluated by the Short-Form 36. Change from baseline to 3 months
Secondary Arterial stiffness Carotid-femoral pulse wave velocity, central pressures and aortic augmentation index and augmentation pressure. Change from baseline to 3 months
Secondary 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
Secondary 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
Secondary Inflammation Plasma levels of inflammatory and anti-inflammatory biomarkers. Change from baseline to 3 months
Secondary Oxidative stress Plasma levels of oxidative stress and antioxidant markers. Change from baseline to 3 months
Secondary Daily physical activity Physical activity will be measured during 7 consecutive days using an accelerometer. Change from baseline to 3 months
Secondary Dietary intake Dietary intake will be assessed using a 4-day food diary. Change from baseline to 3 months
Secondary VO2 max VO2 max will be determined by the Chester step test. Change from baseline to 3 months
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