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Completed

NCT Number: NCT03090529

The Role of Exercise Training in the Treatment of Resistant Hypertension

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.

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Key information

Conditions

Resistant Hypertension

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga, Aveiro, Portugal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

confirmed resistant hypertension, who in the previous 3 months had unchanged medication

Exclusion criteria

  • Patients with secondary hypertension
  • Evidence of target organ damage
  • Patients with heart failure
  • Previous cardiovascular event
  • Peripheral artery disease
  • Renal failure
  • Chronic obstructive pulmonary disease
  • Systolic office blood pressure superior to 180 mmHg
  • Biomechanical limitations to physical activity
  • Those participating in regular physical activity

Treatment and study plan

Exercise group

Other

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

Primary outcomes

  1. Ambulatory blood pressure

    Time frame: Change from Baseline in Blood Pressure at 3 months

    Blood pressure

Secondary outcomes

  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. 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.

  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.

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Collaborators

  • Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga
  • Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos
  • Universidade do Porto
  • University Institute of Maia

Registry information

Acronym: EnRIcH

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 24, 2017
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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