The Role of Exercise Training in the Treatment of Resistant Hypertension (EnRIcH)

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.

Study Overview

• Status: Completed
• Conditions: Resistant Hypertension
• Intervention / Treatment: Other: Exercise Group

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Aveiro, Portugal, 3800
    • Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga
  • Matosinhos, Portugal, 4464-513
    • Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aveiro University
• Collaborators: 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
• Investigators: Study Director: José Mesquita Bastos, MD, PhD, Hospital Infante D. Pedro, Centro Hospitalar Do Baixo Vouga

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Exercise training; Resistant Hypertension; Nitric Oxide; Ambulatory blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 1725/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No