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Hypertension (HTN)NCT07229196

Clinical Trial in Hypertensive Patients Comparing Two Cardiorespiratory Exercise Protocols, Low-volume Sprint Interval Training (SIT) Versus Moderate-intensity Continuous Training (MICT), to Evaluate Decreases in Ambulatory Blood Pressure and Other Clinical Variables.

A study testing SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session. and MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session. in people with Hypertension (HTN), run by Unidad Enfermedades Cardiometabolicas- Hospital Interzonal General Agudos San Martin de La Plata at 1 site in Argentina.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This randomized clinical trial aims to compare two cardiorespiratory exercise training protocols - Sprint Interval Training (SIT), characterized by short, maximal-intensity efforts, versus Moderate-Intensity Continuous Training (MICT) - in patients with arterial hypertension. Read more about this study

Who is it for?
Ages 30 to 59 years
Conditions the study is for
Hypertension (HTN)
What is being tested?
SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session. and MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteArgentina
Study dates
29 Apr 2025to Jan 2027
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 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients of both sexes between 30-59 years of age who meet the definition of hypertension.
  • Hypertension will be defined as:
  • Those patients who report a history of hypertension and are under pharmacological treatment for it (Angiotensin Converting Enzyme Inhibitors/Angiotensin II Receptor Antagonists/Calcium Channel Blockers/Thiazide Diuretics/Beta Blockers) at the time of the evaluation.
  • OR
  • Patients who report a history of hypertension during the evaluation and who, without pharmacological treatment, have average levels ≥140/90 mmHg will also be considered hypertensive.

Who cannot join

  • Extreme body mass index (BMI) <18.5 and ≥35.
  • Patients with office blood pressure readings ≥160/100 mmHg.
  • Patients with high cardiovascular risk conditions such as type II diabetes, chronic kidney disease (<60 milliseconds), history of cerebrovascular disease, coronary artery disease, peripheral arterial disease, or heart failure (Framingham Criteria clinical diagnosis).
  • Pregnant or postpartum women up to 3 months old.
  • Patients with psychophysical limitations that make exercise difficult.
  • Patients with a history of active malignant neoplastic disease under treatment.
  • Elimination Criteria
  • -Patients whose pharmacological treatment is initiated or modified during the follow-up after 3 months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julian Minetto, Physican contact

+542214835429

jjminetto@hotmail.com

Walter Espeche, Doctor (PH) contact

wespeche@gmail.com

Argentina1 site, 1 recruiting
  • Hospital Interzonal General San Martin La Plata

    La Plata, Buenos Aires, 1900

    Julian Minetto, +54 (221) 483-5429, jjminetto@hotmail.com

    Recruiting

Other trials in Argentina

About this study

This randomized clinical trial aims to compare two cardiorespiratory exercise training protocols - Sprint Interval Training (SIT), characterized by short, maximal-intensity efforts, versus Moderate-Intensity Continuous Training (MICT) - in patients with arterial hypertension. The primary objective is to evaluate the impact of both interventions on 24-hour ambulatory systolic blood pressure (ABPM) after a 12-week training period.

Secondary outcomes include diastolic, daytime, and nighttime blood pressure, metabolic and hemodynamic parameters, body composition, and serum myokine levels (IL-6 and α-CGRP).

Read more

Participants aged 30-59 years with diagnosed hypertension but without high cardiovascular risk will be recruited from the Cardio-Metabolic Disease Unit of Hospital San Martín (La Plata, Argentina). After a two-week familiarization period, eligible participants will be randomized to SIT or MICT groups.

The intervention will last 12 weeks, with three supervised sessions per week. The study will provide valuable information about the effectiveness, safety, and clinical applicability of brief, high-intensity exercise for blood pressure control in hypertensive patients.

Read the detailed description

Introduction

Cardiovascular disease remains the leading cause of mortality worldwide, with hypertension as a major modifiable risk factor. Exercise is a key non-pharmacological strategy for blood pressure management. While moderate-intensity continuous training (MICT) is well established, Sprint Interval Training (SIT) - characterized by short (10-30 s) bursts of maximal effort - has shown promising metabolic and cardiovascular benefits with significantly shorter session durations.

Despite growing interest, few clinical trials have evaluated SIT in hypertensive populations using ambulatory blood pressure monitoring (ABPM), which provides better prognostic information than office measurements. Furthermore, the biological mechanisms underlying exercise-induced benefits may involve myokines such as interleukin-6 (IL-6) and α-calcitonin gene-related peptide (α-CGRP), both associated with improved cardiometabolic health.

Objectives

Primary objective:

To compare the effect of SIT versus MICT on 24-hour systolic ambulatory blood pressure after 12 weeks of structured exercise.

Secondary objectives:

Assess changes in diastolic, daytime, and nighttime ambulatory blood pressure.

Evaluate office BP, anthropometric variables (weight, waist circumference, body fat percentage), and metabolic profile (lipids, glucose, TG/HDL ratio).

Assess changes in maximal oxygen consumption (VO₂max), non-invasive hemodynamic parameters, and handgrip strength.

Determine post-training serum concentrations of IL-6 and α-CGRP as biomarkers of exercise response.

Analyze acute hemodynamic responses and adherence to training.

Materials and Methods

Design:

Open-label, randomized, parallel-group clinical trial with pre- and post-intervention evaluations.

Population:

Hypertensive adults (30-59 years) attending the Cardio-Metabolic Disease Unit of Hospital San Martín (La Plata, Argentina).

Inclusion criteria:

Confirmed hypertension (treated or untreated).

BMI 18.5-34.9 kg/m².

Exclusion criteria:

Office BP ≥160/100 mmHg.

Diabetes, chronic kidney disease (eGFR <60 mL/min), coronary or cerebrovascular disease, pregnancy, or severe comorbidities.

Intervention:

Participants undergo a 2-week familiarization phase before randomization into two groups:

MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session.

SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session.

Both groups train three times per week for 12 weeks, under professional supervision. Blood pressure, heart rate, and oxygen saturation will be monitored during sessions for safety.

Evaluations:

At baseline and post-intervention:

Office and 24-hour ABPM measurements.

Anthropometry and laboratory tests (lipid profile, glucose, IL-6, α-CGRP via ELISA).

Impedance cardiography and pulse wave velocity for non-invasive hemodynamics.

Graded exercise test to determine VO₂max.

Handgrip strength test.

Sample size:

A total of 14-20 participants (7-10 per group) are required to detect a 5 mmHg difference in 24-hour systolic BP with 80% power and α=0.05.

Statistical analysis:

Between-group comparisons will use t-tests or Wilcoxon rank-sum tests depending on data distribution. Within-group pre/post differences will be analyzed with paired tests. Analyses will follow the intention-to-treat principle, with additional per-protocol analysis for participants achieving ≥75% adherence.

Ethics:

The study is classified as minimal risk and adheres to the Declaration of Helsinki (2024). Approved by the Ethics Committee of Hospital San Martín de La Plata (Reg. No. 070/2019). All participants will provide written informed consent.

Being tested
SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session., MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session.
Keywords
hypertension, exercise, low-volume sprint interval training, moderate-intensity continuous training, High-Intensity Interval Training
Medical subject headings
Hypertension, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session.Behavioural

    SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session.

    Three times per week for 12 weeks

  • MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session.Behavioural

    MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session. three times per week for 12 week

Study groups in NCT07229196
Study groupRoleWhat they receive
MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per sessionActive comparatorMICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session
Receives: Behavioral: MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session.
SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min)ExperimentalSIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session.
Receives: Behavioral: SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the differences between both exercise protocols in 24-hour systolic ambulatory blood pressure (ABPM) values after the 12-week programmed exercise

    Measured: after the 12-week programmed exercise

Secondary outcomes (7)
  1. To evaluate the differences between both exercise protocols in 24-hour diastolic ambulatory blood pressure (ABPM) values after the 12-week programmed exercise

    Measured: after the 12-week programmed exercise

  2. To evaluate the differences between both exercise protocols in daytime and nighttime ambulatory ABPM values after the 12-week programmed exercise.

    Measured: after the 12-week programmed exercise

  3. To evaluate the differences in other clinical characteristics such as office SBP and DBP, weight, waist circumference, and percentage of body fat through skinfold thickness measurements after the 12-week programmed exercise.

    Measured: after the 12-week programmed exercise.

  4. To evaluate the differences between both exercise protocols in insulin resistance and lipid profile parameters (TG/HDL, TG/glycemia, glycemia, LDL) after the 12-week programmed exercise

    Measured: after the 12-week programmed exercise

  5. To evaluate the differences between both exercise protocols in maximal oxygen uptake capacity (Vo2max) after the 12-week programmed exercise

    Measured: after the 12-week programmed exercise

  6. To evaluate the differences between both exercise protocols in noninvasive hemodynamics (peripheral resistance/cardiac index) after the 12-week programmed exercise

    Measured: after the 12-week programmed exercise

  7. To determine plasma levels of interleukin-6 and calcitonin gene-related peptide alpha after the 12-week programmed exercise.

    Measured: after the 12-week programmed exercise.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2025
  2. Study start29 Apr 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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
Open-label, randomized, parallel-group clinical trial
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07229196
Sponsor's protocol ID
HSMLP2025/178
Status last verified
Oct 2025
First submitted
13 Nov 2025
Last updated
14 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Potentially yes, given the conditions of anonymity as well as the instances of prior agreement and grounds for the reques

Questions about this trial

What is this clinical trial studying?

A study testing SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session. and MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session. in people with Hypertension (HTN), run by Unidad Enfermedades Cardiometabolicas- Hospital Interzonal General Agudos San Martin de La Plata at 1 site in Argentina.

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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 Nov 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 Argentina. 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?

Contact Julian Minetto, Physican (+542214835429, jjminetto@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the differences between both exercise protocols in 24-hour systolic ambulatory blood pressure (ABPM) values after the 12-week programmed exercise (time frame: after the 12-week programmed exercise). 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 14 Nov 2025.

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