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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- To evaluate the differences between both exercise protocols in 24-hour systolic ambulatory blood pressure (ABPM) values after the 12-week programmed exercise
Study Overview
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≥
- •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.
Arms & Interventions
MICT 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
Intervention: MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session. (Behavioral)
SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min)
SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session.
Intervention: 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)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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 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 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)
- To evaluate the differences between both exercise protocols in noninvasive hemodynamics (peripheral resistance/cardiac index) after the 12-week programmed exercise(after the 12-week programmed exercise)
- To determine plasma levels of interleukin-6 and calcitonin gene-related peptide alpha after the 12-week programmed exercise.(after the 12-week programmed exercise.)
Investigators
Julian Minetto
Physican
Unidad Enfermedades Cardiometabolicas- Hospital Interzonal General Agudos San Martin de La Plata