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

• ClinicalTrials.gov Identifier: NCT03090529
• Recruitment Status: Completed
• First Posted: March 24, 2017
• Last Update Posted: December 17, 2020
• 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
• Information provided by (Responsible Party): Fernando Ribeiro, Aveiro University

Tracking Information

• First Submitted Date: March 13, 2017
• First Posted Date: March 24, 2017
• Last Update Posted Date: December 17, 2020
• Actual Study Start Date: March 30, 2017
• Actual Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 20, 2017)

Ambulatory blood pressure [ Time Frame: Change from Baseline in Blood Pressure at 3 months ]

Blood pressure

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 8, 2020)

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

Original Secondary Outcome Measures (submitted: March 20, 2017)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Role of Exercise Training in the Treatment of Resistant Hypertension
• Official Title: The Role of Exercise Training in the Treatment of Resistant Hypertension
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Resistant Hypertension

Intervention

Other: Exercise Group

The 12-week exercise-training program will include three sessions of aerobic exercise per week

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 20, 2017): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 30, 2020
• Actual Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Portugal

Administrative Information

• NCT Number: NCT03090529
• Other Study ID Numbers: 1725/2014
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Fernando Ribeiro, Aveiro University
• Study 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

• PRS Account: Aveiro University
• Verification Date: December 2020