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.

Recruiting · NCT07229196 · Interventional (participants receive a specific treatment)

View the official record on ClinicalTrials.gov →

Interventions studied

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.

What this trial is about

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.

Who can take part

Age range

30 Years to 59 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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.

Exclusion criteria

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.

Where it is running

1 location listed.

Hospital Interzonal General San Martin La Plata - La Plata, Buenos Aires, Argentina

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →