Clinical trial NCT03090529: The Role of Exercise Training in the Treatment of Resistant Hypertension
Official title: The Role of Exercise Training in the Treatment of Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistant Hypertension
Keywords: Exercise training
Ambulatory blood pressure
Resistant Hypertension
Nitric Oxide
Lead sponsor: Aveiro University
Sponsor class: OTHER
Collaborators: name: University Institute of Maia
name: Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga
name: Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos
name: Cintesis & Departamento de Medicina da Faculdade de Medicina do Porto
First posted: 2017-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ambulatory blood pressure
timeFrame: Change from Baseline in Blood Pressure at 3 months
Secondary outcomes:
measure: Casual blood pressure
timeFrame: Change from baseline to 3 months
measure: Body composition
timeFrame: Change from baseline to 3 months
measure: Health-related quality of life
timeFrame: Change from baseline to 3 months
measure: Arterial stiffness
timeFrame: Change from baseline to 3 months
measure: Heart rate variability
timeFrame: Change from baseline to 3 months
measure: Circulating number of endothelial progenitor cells, circulating endothelial cells, nitric oxide and endothelial Nitric Oxide Synthase
timeFrame: Change from baseline to 3 months
measure: Inflammation
timeFrame: Change from baseline to 3 months
measure: Oxidative stress
timeFrame: Change from baseline to 3 months
measure: Daily physical activity
timeFrame: Change from baseline to 3 months
measure: Dietary intake
timeFrame: Change from baseline to 3 months
measure: VO2 max
timeFrame: Change from baseline to 3 months
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga
city: Matosinhos
country: Portugal
facility: Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos
Study officials:
affiliation: Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga
name: José Mesquita Bastos, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Lopes S, Mesquita-Bastos J, Garcia C, Bertoquini S, Ribau V, Teixeira M, Ribeiro IP, Melo JB, Oliveira J, Figueiredo D, Guimaraes GV, Pescatello LS, Polonia J, Alves AJ, Ribeiro F. Effect of Exercise Training on Ambulatory Blood Pressure Among Patients With Resistant Hypertension: A Randomized Clinical Trial. JAMA Cardiol. 2021 Nov 1;6(11):1317-1323. doi: 10.1001/jamacardio.2021.2735.