Aerobic Exercise and Resistant Hypertension

September 12, 2025 updated by: Ruilope, Universidad Europea de Madrid

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28670
        • Universidad Europea Madrid (UEM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Moderate-intensity interval training (MIIT)
24 participants with resistant hypertension will perform moderate-intensity interval training.
Other: Moderate-intensity interval training (MIIT)
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.
Experimental: Moderate-intensity continuous training (MICT)
24 participants with resistant hypertension will perform moderate-intensity continuous training.
Other: Moderate-intensity continuous training (MICT)
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).
No Intervention: Usual care
24 participants with resistant hypertension will maintain usual care for 4 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to immediate post-treatment (4 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to immediate post-treatment (4 months)
Changes in albuminuria
Time Frame: Baseline to immediate post-treatment (4 months)
Albuminuria will be determined from the albumin/creatinine ratio in urine.
Baseline to immediate post-treatment (4 months)
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.
Baseline to immediate post-treatment (4 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline to immediate post-treatment (4 months)
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.
Baseline to immediate post-treatment (4 months).
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.
Baseline to immediate post-treatment (4 months).
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.
Baseline to immediate post-treatment (4 months).
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).
Baseline to immediate post-treatment (4 months)
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.
Baseline to immediate post-treatment (4 months)
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.
Baseline to immediate post-treatment (4 months)
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).
Baseline to immediate post-treatment (4 months)
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.
Baseline to immediate post-treatment (4 months)
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.
Baseline to immediate post-treatment (4 months)
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.
Baseline to immediate post-treatment (4 months)
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.
Baseline to immediate post-treatment (4 months)
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.
Baseline to immediate post-treatment (4 months)
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.
Baseline to immediate post-treatment (4 months)
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.
Baseline to immediate post-treatment (4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Europea de Madrid

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luis Ruilope, PhD, UEM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UEM

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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