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

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ClinicalTrials.gov Identifier: NCT03090529
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : November 1, 2018
Sponsor:
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
Information provided by (Responsible Party):
Fernando Ribeiro, Aveiro University

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.

Condition or disease Intervention/treatment Phase
Resistant Hypertension Other: Exercise Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Exercise Training in the Treatment of Resistant Hypertension
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Ambulatory blood pressure [ Time Frame: Change from Baseline in Blood Pressure at 3 months ]
    Blood pressure


Secondary Outcome Measures :
  1. Casual blood pressure [ Time Frame: Change from baseline to 3 months ]
    Blood pressure

  2. Body composition [ Time Frame: Change from baseline to 3 months ]
    Body composition

  3. Quality of life [ Time Frame: Change from baseline to 3 months ]
    Health-related quality of life will be evaluated by the Short-Form 36.

  4. Arterial stiffness [ Time Frame: Change from baseline to 3 months ]
    Carotid-femoral pulse wave velocity, central pressures and aortic augmentation index and augmentation pressure.

  5. Heart rate variability [ Time Frame: 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.

  6. Circulating number of endothelial progenitor cells, circulating endothelial cells, nitric oxide and endothelial Nitric Oxide Synthase [ Time Frame: Change from baseline to 3 months ]
    These markers will inform endothelial function, damage and repair

  7. Inflammation [ Time Frame: Change from baseline to 3 months ]
    Plasma levels of inflammatory and anti-inflammatory biomarkers.

  8. Oxidative stress [ Time Frame: Change from baseline to 3 months ]
    Plasma levels of oxidative stress and antioxidant markers.

  9. Daily physical activity [ Time Frame: Change from baseline to 3 months ]
    Physical activity will be measured during 7 consecutive days using an accelerometer.

  10. Dietary intake [ Time Frame: Change from baseline to 3 months ]
    Dietary intake will be assessed using a 4-day food diary.

  11. VO2 max [ Time Frame: Change from baseline to 3 months ]
    VO2 max will be determined by the Chester step test.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090529


Contacts
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Contact: Fernando Ribeiro, PhD +351234372455 ext 27113 fernando.ribeiro@ua.pt
Contact: Alberto Alves, PhD +351229866000 ext 1313 ajalves@ismai.pt

Locations
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Portugal
Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga Recruiting
Aveiro, Portugal, 3800
Contact: José Mesquita-Bastos, MD, PhD       mesquitabastos@gmail.com   
Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos Recruiting
Matosinhos, Portugal, 4464-513
Contact: Jorge Polonia, MD, PhD       jjpolonia@gmail.com   
Principal Investigator: Jorge Polonia, MD, PhD         
Sponsors and Collaborators
Aveiro University
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
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Study Director: José Mesquita Bastos, MD, PhD Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga

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Responsible Party: Fernando Ribeiro, Adjunct Professor, Aveiro University
ClinicalTrials.gov Identifier: NCT03090529     History of Changes
Other Study ID Numbers: 1725/2014
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fernando Ribeiro, Aveiro University:
Exercise training
Ambulatory blood pressure
Resistant Hypertension
Nitric Oxide
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases