Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05563077

Aerobic Exercise and Resistant Hypertension

This study will examine the effects of 4 months of aerobic interval training versus continuous aerobic training on ambulatory blood pressure (ABP) and novel plasma protein biomarkers in patients with resistant hypertension. A randomized controlled trial will be performed including two exercise groups and a control group: a) moderate-intensity interval training (MIIT); b) moderate-intensity continuous training (MICT); c) usual care. MIIT could represent a superior training modality that exceeds the benefits of MICT in patients with resistant hypertension.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Resistant Hypertension Behavior Motor Activity

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea Madrid (UEM)

Madrid, 28670, Spain

About this study

Hypertension is associated with an increased risk of cardiovascular morbidity and mortality, and its high prevalence remains a worldwide concern. Ambulatory blood pressure monitoring (ABPM) is recognized in the diagnosis and management of hypertension, and can control blood pressure better than clinic assessment. Different studies have examined the effects of aerobic training on ABP in patients with hypertension, but the effects of moderate-intensity interval training (MIIT) and moderate-intensity continuous training (MICT) on ABP and novel plasma protein biomarkers that could potentially serve to identify cardiovascular risk, have not yet been examined in patients with resistant hypertension.To fill this gap, our aims are to determine the effects of MIIT and MICT for 4 months on ABP (primary endpoint), and on proteomic biomarkers (secondary endpoints) in patients with resistant hypertension. A total of 72 participants will be randomly divided into three groups: the first group (n=24) will perform MIIT, the second group (n=24) will perform MICT, and the third control group (n=24) will maintain usual care for 4 months. All will receive usual care for 4 months, with the structured physical exercise as the only relevant change in the intervention groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with resistant hypertension (RH) (i.e., systolic BP/diastolic BP >130/80 mmHg according to the American College of Cardiology/American Heart Association) despite the concurrent use of three or more antihypertensive drugs - commonly including a diuretic, a long-acting calcium channel blocker, and a blocker of the renin-angiotensin system. RH also includes patients whose BP achieves target values on ≥ 4 antihypertensive. medications (i.e., 'controlled' RH).
  • Adherence to prescribed medications.
  • Willing to be randomized to one of the 3 groups.
  • Informed consent.

Exclusion criteria

  • Exclusion criteria will include exercising more than 30 minutes on 3 days or more weekly.
  • Severe ischemic heart disease, major psychiatric disorder and other health contraindications that may interfere in the evaluations or interventions.

Treatment and study plan

Moderate-Intensity Interval Training (MIIT)

Other

MIIT group: participants will perform 3 sessions per week for 4 months. Each session will involve a ∼3 min warm-up (joint mobility exercises and walking at ∼2.2 METs), a ∼40-50 min main period (∼6-7 reps of 4 min at ∼4.2 METs, with 3 min of active recovery at ∼2.2 METs between each interval), and a ∼3-min cool-down (joint mobility exercises and walking at ∼2.2 METs). We will select the same aerobic dose of training (i.e., kcal/kg of body weight per week) to match total energy expenditure in both exercise groups.

Moderate-Intensity Continuous Training (MICT)

Other

MICT group: participants will perform 3 sessions per week for 4 months. Each session will involve a ∼3 min warm-up (joint mobility exercises and walking at ∼2.2 METs), a ∼40-50 min main period at ∼3.2 METs, and a ∼3-min cool-down (joint mobility exercises and walking at ∼2.2 METs).

Primary outcomes

  1. Change in 24-hour ambulatory blood pressure

    Time frame: Baseline to immediate post-treatment (4 months)

    Ambulatory SBP and DBP will be recorded with a validated oscillometric device over 24 hours.

Secondary outcomes

  1. Change in plasma proteome

    Time frame: Baseline to immediate post-treatment (4 months)

    Olink's Proximity Extension Assay (PEA) technology, using the inflammation panel, will be used to evaluate changes in the plasma proteome.

  2. Changes in albuminuria

    Time frame: Baseline to immediate post-treatment (4 months)

    Albuminuria will be determined from the albumin/creatinine ratio in urine.

  3. Changes in glomerular filtration rate

    Time frame: Baseline to immediate post-treatment (4 months)

    The estimated glomerular filtration rate (eGFR) will be determined from serum creatinine levels using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

Other outcomes

  1. Change in aerobic capacity

    Time frame: Baseline to immediate post-treatment (4 months).

    VO2 will be measured breath-by-breath using a gas exchange analysis system.

  2. Change in body composition

    Time frame: Baseline to immediate post-treatment (4 months)

    Dual-energy X-ray absorptiometry (DXA) scans will performed to measure body composition (fat mass and lean mass).

  3. Change in lipid profiles

    Time frame: Baseline to immediate post-treatment (4 months).

    Blood analysis will be performed to evaluate HDL-C, LDL-C, total cholesterol, and triglyceride levels.

  4. Change in echocardiography-determined left ventricular ejection fraction

    Time frame: Baseline to immediate post-treatment (4 months).

    The percentage of blood volume ejected from the left ventricle with each systolic contraction [(left ventricular end-diastolic volume - left-ventricular end-systolic volume)/ left ventricular end-diastolic volume] × 100.

  5. Change in echocardiography-determined relative wall thickness (RWT)

    Time frame: Baseline to immediate post-treatment (4 months)

    The RWT will be calculated using the following formula:

    RWT = (Interventricular septum + left ventricular posterior wall thickness)/Left ventricular end-diastolic diameter).

  6. Change in echocardiography-determined left ventricular global longitudinal strain (LV-GLS)

    Time frame: Baseline to immediate post-treatment (4 months)

    Two-dimensional speckle tracking echocardiography will be used to determine LV-GLS The Auto Strain function will be used for out-of-cart strain assessment on saved records. GLS values will be obtained by analyzing multi-camera perspectives, including two-, three- and four-camera views.

  7. Change in echocardiography-determined left ventricular end-diastolic diameter (LVEDD)

    Time frame: Baseline to immediate post-treatment (4 months)

    LVEDD will be measured using two-dimensional guided M-mode imaging following recommendations from the American Society of Echocardiography.

  8. Change in echocardiography-determined left ventricular (LV) mass

    Time frame: Baseline to immediate post-treatment (4 months)

    LV dimensions will be expressed relative to body surface area (in m x^2).

  9. Change in echocardiography-determined left ventricular end- diastolic volume (LVEDV)

    Time frame: Baseline to immediate post-treatment (4 months)

    We will use the following equation to measure LVEDV:

    LVEDV (mL) = [7.0/(2.4 + Left ventricular end-diastolic diameter)] × Left ventricular end-diastolic diameter x^3.

  10. Change in echocardiography-determined interventricular septal wall thickness (IVS)

    Time frame: Baseline to immediate post-treatment (4 months)

    IVS will be measured using two-dimensional guided M-mode imaging following recommendations from the American Society of Echocardiography.

  11. Change in echocardiography-determined left ventricular posterior wall thickness (LVPW) (diastole)

    Time frame: Baseline to immediate post-treatment (4 months)

    LVPW will be measured using two-dimensional guided M-mode imaging following recommendations from the American Society of Echocardiography.

  12. Change in carotid intima-media thickness (IMT)

    Time frame: Baseline to immediate post-treatment (4 months)

    The IMT will be measured in a long axis view in each distal common carotid artery, at least 5 mm proximal to the bifurcation, as the mean distance between the luminal-intimal and the medial-adventitial interfaces over a 10-mm length in the far wall.

  13. Change in femoral intima-media thickness (IMT)

    Time frame: Baseline to immediate post-treatment (4 months)

    The IMT will be measured in a long axis view in each distal common carotid artery, at least 5 mm proximal to the bifurcation, as the mean distance between the luminal-intimal and the medial-adventitial interfaces over a 10-mm length in the far wall.

  14. Change in carotid plaque maximal thickness

    Time frame: Baseline to immediate post-treatment (4 months)

    A plaque will be defined as the presence of a focal wall thickening ≥50% greater than the surrounding vessel wall, a focal region with an IMT measurement ≥1.5 mm, or a ≥0.5 cm protrusion into the lumen exceeding the IMT.

  15. Change in femoral plaque maximal thickness

    Time frame: Baseline to immediate post-treatment (4 months)

    A plaque will be defined as the presence of a focal wall thickening ≥50% greater than the surrounding vessel wall, a focal region with an IMT measurement ≥1.5 mm, or a ≥0.5 cm protrusion into the lumen exceeding the IMT.

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Effects of Two Types of Aerobic Training on Ambulatory Blood Pressure in Hypertensives: a Systems Biology Approach

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2022
Registry last updated
Sep 18, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.