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NCT Number: NCT07470450

Acute and Chronic Effects of Combined Training on BP in Hypertensives

Dynamic strength training (DST) is widely recognized for promoting neuromuscular adaptations such as increased strength and hypertrophy. It is currently endorsed by treatment and prevention guidelines for systemic arterial hypertension (SAH) due to its significant effect on lowering blood pressure (BP). However, when comparing BP reduction values, isometric strength training (IST) stands out with greater magnitudes of BP reduction, although without the neuromuscular adaptations seen in DST. Given their similarities, a combination of these strategies through combined strength training (CST) is possible but has not yet been evaluated. The researchers hypothesized that CST may have an additive effect compared with DST and IST alone in reducing ambulatory BP. Therefore, the objective of the present thesis was to evaluate and compare the effects of CST, DST, and IST on regulatory variables of ambulatory BP in medicated middle-aged hypertensive patients. This thesis is structured in two parts: (1) a crossover study with medicated middle-aged hypertensive patients to identify autonomic, endothelial, and vascular responses related to ambulatory BP after a single session of CST, DST, and IST; and (2) a randomized clinical trial to assess the chronic effects of CST, DST, and IST on regulatory variables of ambulatory BP in medicated middle-aged hypertensive patients.

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Key information

Conditions

Dynamic Strength Exercise Session Autonomic Nervous System Diseases Cardiovascular Diseases Combined Exercise Session Combined Strength Training Control Session (CON) Dynamic Strength Training Hypotension Isometric Strength Exercise Session Isometric Strength Training Nervous System Diseases Orthostatic Intolerance Post-Exercise Hypotension Primary Dysautonomias Vascular Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 91420-550, Brazil

About this study

"This thesis is structured in two sequential stages:

A randomized crossover trial involving medicated middle-aged hypertensive patients to identify autonomic, endothelial, and vascular responses on ambulatory blood pressure following a single session of Combined Strength Training (CST), Dynamic Strength Training (DST), and Isometric Strength Training (IST), compared to a control session.

A randomized controlled trial to assess the chronic effects (8 weeks) of CST and DST on the regulatory variables of ambulatory blood pressure in medicated middle-aged hypertensive patients, compared to a non-exercising control group."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of stage 1 or stage 2 hypertension, according to current guidelines.

Sedentary lifestyle (no participation in structured exercise training for at least 6 months).

Age between 18 and 60 years. Stable antihypertensive pharmacological treatment for at least 4 weeks before enrollment.

Ability to perform resistance exercise.

Exclusion criteria

Symptomatic cardiovascular disease. Heart failure. Unstable angina. Uncontrolled diabetes mellitus (HbA1c > 8%). Renal insufficiency. Musculoskeletal disorders or physical limitations that contraindicate resistance exercise.

Changes in antihypertensive medication within the 4 weeks prior to enrollment or during the study protocol.

Current smoking. Excessive alcohol consumption.

Treatment and study plan

Combined Strength Training

Other

Participants in this group undergo two phases. Phase 1: A single acute exercise session consisting of 8 resistance exercises (3 sets of 11 repetitions with a 10-second isometric hold at the end of each set; 1s concentric/2s eccentric phases). Phase 2: An 8-week chronic intervention period, performing the same combined protocol 3 times a week, with intensity progressing from 50% to 65% of 1RM.

Dynamic strength training

Other

Participants in this group go through two phases.

Phase 1: A single acute exercise session consisting of 8 resistance exercises (3 sets of 14 repetitions, 1 second concentric phase and 2 seconds eccentric phase, 30 seconds of rest between sets and 90 seconds between exercises) at 50% of 1RM.

Phase 2: An 8-week chronic intervention period, performing the same dynamic resistance protocol 3 times a week, with intensity progressing from 50% to 65% of 1RM.

Acute Isometric Exercise Session.

Other

Participants in this group undergo a single acute exercise session consisting of 8 resistance exercises performed isometrically. The protocol includes 3 sets per exercise, with each set consisting of a 10-second static contraction at 50% of 1RM, with 30 seconds of rest between sets and 90 seconds between exercises

Control Session and Follow-up

Other

Participants in this group undergo two phases. Phase 1: A single acute control session consisting of quiet rest in a seated position for the same duration as the exercise sessions. Phase 2: An 8-week follow-up period where participants maintain their usual daily activities and pharmacological treatment without any structured exercise program.

Primary outcomes

  1. 24-hour Ambulatory Blood Pressure (Systolic, Diastolic, and Mean)

    Time frame: Baseline and 8 weeks

    Average systolic blood pressure measured over a 24-hour period using an automated ambulatory monitor (ABPM). This measure assesses the chronic effect of the 8-week training protocols compared to baseline.

Secondary outcomes

  1. Acute 24-hour Ambulatory Blood Pressure (Systolic, Diastolic, and Mean)

    Time frame: 24 hours post-intervention

    Average systolic blood pressure measured over a 24-hour period following a single session of each intervention (Dynamic, Combined, Isometric, and Control) to evaluate post-exercise hypotension. This was conducted in a crossover design.

  2. Acute Post-Exercise Blood Pressure Response

    Time frame: Baseline, 30 minutes, and 60 minutes post-exercise.

    Systolic and diastolic blood pressure measured at rest (pre-intervention) and at 30 and 60 minutes following a single exercise session to evaluate the immediate post-exercise hypotension (PEH).

  3. Vascular Endothelial Function - Chronic (Flow-Mediated Dilation)

    Time frame: Baseline and 8 weeks

    Percentage of brachial artery dilation measured via high-resolution ultrasound to evaluate the chronic adaptations of vascular endothelial function after the 8-week intervention.

  4. Vascular Endothelial Function - Acute Response (Flow-Mediated Dilation)

    Time frame: Baseline, 30 minutes, and 60 minutes post-exercise.

    Acute changes in the percentage of brachial artery dilation following a single session of exercise. This measure evaluates the transient endothelial response at different time points.

  5. Cardiac Autonomic Modulation - Chronic (Heart Rate Variability)

    Time frame: Baseline and 8 weeks.

    Analysis of heart rate variability (HRV) parameters in both time and frequency domains (e.g., SDNN, RMSSD, LF, HF) to evaluate chronic adaptations in cardiac autonomic control after the 8-week intervention.

  6. Cardiac Autonomic Modulation - Acute Response (Heart Rate Variability)

    Time frame: Baseline, 30 minutes, and 60 minutes post-exercise.

    Acute changes in heart rate variability parameters following a single session of exercise. This evaluates the immediate autonomic recovery and sympathetic-vagal balance at different time points.

  7. Office Blood Pressure Adaptation (Weekly Progression)

    Time frame: Baseline and weekly for 8 weeks.

    Assessment of the progression of resting systolic and diastolic blood pressure measured before exercise sessions throughout the 8-week intervention to evaluate the time course of blood pressure adaptations.

  8. Blood-based Biomarkers of Cardiovascular Health

    Time frame: Baseline and 8 weeks

    Analysis of blood samples to evaluate biochemical markers related to cardiovascular health, such as markers of inflammation, oxidative stress, or nitric oxide bioavailability, to investigate the mechanisms underlying blood pressure changes.

  9. Acute Blood-based Biomarkers Response

    Time frame: Baseline, 30 minutes, and 60 minutes post-exercise.

    Analysis of blood samples to evaluate the acute response of biochemical markers related to cardiovascular and endothelial health (e.g., nitric oxide metabolites, inflammatory cytokines, or oxidative stress markers) following a single session of exercise.

  10. Body Composition (Skinfold Thickness)

    Time frame: Baseline and 8 weeks

    Assessment of body composition using skinfold thickness measurements to estimate body fat percentage and lean body mass. This measure monitors physical changes and ensures that any observed blood pressure adaptations are not solely due to changes in body fat or weight.

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study title

Acute And Chronic Effects Of Combined Strength Training On Regulatory Variables Of Ambulatory Blood Pressure In Medicated Hypertensive Patients

Acronym: COMBAT-H

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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