Resistant HypertensionNCT05563077
Aerobic Exercise and Resistant Hypertension
A study testing Moderate-intensity interval training (MIIT) and Moderate-intensity continuous training (MICT) in people with Resistant Hypertension, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Moderate-intensity interval training (MIIT) and Moderate-intensity continuous training (MICT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 5 Oct 2022to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Resistant Hypertension
- Being tested
- Moderate-intensity interval training (MIIT), Moderate-intensity continuous training (MICT)
- Keywords
- physical exercise, blood pressure, proteomics, resistant hypertension
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity interval training (MIIT) | Experimental | 24 participants with resistant hypertension will perform moderate-intensity interval training. Receives: Other: Moderate-intensity interval training (MIIT) |
| Moderate-intensity continuous training (MICT) | Experimental | 24 participants with resistant hypertension will perform moderate-intensity continuous training. Receives: Other: Moderate-intensity continuous training (MICT) |
| Usual care | No intervention | 24 participants with resistant hypertension will maintain usual care for 4 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour ambulatory blood pressure
Ambulatory SBP and DBP will be recorded with a validated oscillometric device over 24 hours.
Measured: Baseline to immediate post-treatment (4 months)
Secondary outcomes (3)
Change in plasma proteome
Olink's Proximity Extension Assay (PEA) technology, using the inflammation panel, will be used to evaluate changes in the plasma proteome.
Measured: Baseline to immediate post-treatment (4 months)
Changes in albuminuria
Albuminuria will be determined from the albumin/creatinine ratio in urine.
Measured: Baseline to immediate post-treatment (4 months)
Changes in glomerular filtration rate
The estimated glomerular filtration rate (eGFR) will be determined from serum creatinine levels using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Measured: Baseline to immediate post-treatment (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start5 Oct 2022
- Primary completion1 Nov 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample of this study will be randomized in a 1:1:1 ratio (www.randomizer.org) based on a computer-generated random allocation sequence, and will be concealed using sequentially numbered, opaque, sealed envelopes to MIIT, MICT and control groups.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruilope, Universidad Europea de Madrid
- Investigators
- Luis Ruilope, PhD, Principal investigator, UEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563077
- Sponsor's protocol ID
- UEM
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Types of Aerobic Training on Ambulatory Blood Pressure in Hypertensives: a Systems Biology Approach
- ClinicalTrials.gov ID
- NCT05563077
- Acronym / sponsor ID
- UEM
- Conditions
- Resistant Hypertension
- Keywords
- physical exercise, blood pressure, proteomics, resistant hypertension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The sample of this study will be randomized in a 1:1:1 ratio (www.randomizer.org) based on a computer-generated random allocation sequence, and will be concealed using sequentially numbered, opaque, sealed envelopes to MIIT, MICT and control groups.
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity interval training (MIIT) | Experimental | Other: Moderate-intensity interval training (MIIT)24 participants with resistant hypertension will perform moderate-intensity interval training. |
| Moderate-intensity continuous training (MICT) | Experimental | Other: Moderate-intensity continuous training (MICT)24 participants with resistant hypertension will perform moderate-intensity continuous training. |
| Usual care | No intervention | –24 participants with resistant hypertension will maintain usual care for 4 months. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Moderate-intensity interval training (MIIT) |
| 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). | Other | Moderate-intensity continuous training (MICT) |
Primary outcome
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.
3 secondary outcomes
Change in plasma proteome
Time frame: Baseline to immediate post-treatment (4 months)
Changes in albuminuria
Time frame: Baseline to immediate post-treatment (4 months)
Changes in glomerular filtration rate
Time frame: Baseline to immediate post-treatment (4 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Ruilope, PhD principal investigator
UEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-intensity interval training (MIIT) and Moderate-intensity continuous training (MICT) in people with Resistant Hypertension, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour ambulatory blood pressure (time frame: Baseline to immediate post-treatment (4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.