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.

NCT07229196 | Recruiting

• 1 other identifier: HSMLP2025/178
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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). 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.

Conditions

Hypertension (HTN)

Keywords

hypertension; exercise; low-volume sprint interval training; moderate-intensity continuous training; High-Intensity Interval Training

Outcome Measures

Primary Outcomes (1)

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

  after the 12-week programmed exercise

Secondary Outcomes (7)

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

  after the 12-week programmed exercise

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

  after the 12-week programmed exercise

• 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.

  after the 12-week programmed exercise.

• 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

  after the 12-week programmed exercise

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

  after the 12-week programmed exercise

Study Arms (2)

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

ACTIVE COMPARATOR

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

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)

EXPERIMENTAL

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

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.

Interventions

SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session. 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. Three times per week for 12 weeks

SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min)

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

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

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

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unidad Enfermedades Cardiometabolicas- Hospital Interzonal General Agudos San Martin de La Plata: lead

Study Sites (1)

Hospital Interzonal General San Martin La Plata

La Plata, Buenos Aires, 1900, Argentina

RECRUITING

MeSH Terms

Conditions

Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Walter Espeche

  Hospital Interzonal General San Martin

  PRINCIPAL INVESTIGATOR

• Julian Minetto, Physican

  Hospital interzonal general agudos San Martin de La Plata

  PRINCIPAL INVESTIGATOR

• Matias Santamaria

  Hospital interzonal general agudos San Martin de La Plata

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Minetto, Physican

CONTACT

+542214835429; jjminetto@hotmail.com

Walter Espeche, Doctor (PH)

CONTACT

wespeche@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physican

Model Details: Open-label, randomized, parallel-group clinical trial

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-10

Locations

AR (1)