The Role of Exercise Training in the Treatment of Resistant Hypertension

Resistant Hypertension Clinical Trial

— EnRIcH  

Official title:

The Role of Exercise Training in the Treatment of Resistant Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090529
• Other study ID #: 1725/2014
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

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