RecruitingNot ApplicableNCT07229196

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.


Sponsor

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

Enrollment

20 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 59 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria8

  • 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.

Interventions

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

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

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


Locations(1)

Hospital Interzonal General San Martin La Plata

La Plata, Buenos Aires, Argentina

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NCT07229196


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