NCT07470450

Brief Summary

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. Our hypothesis is that CST may have an additive effect compared to DST and IST alone in reducing ambulatory BP. Thus, our objective is 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 on ambulatory BP after a single session of CST, DST, and IST. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 9, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

Ambulatory Blood Pressure MonitoringResistence trainingIsometric exercisePost-Exercise hypotensionEndothelial Function

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline and 8 weeks

Secondary Outcomes (10)

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

    24 hours post-intervention

  • Acute Post-Exercise Blood Pressure Response

    Baseline, 30 minutes, and 60 minutes post-exercise.

  • Vascular Endothelial Function - Chronic (Flow-Mediated Dilation)

    Baseline and 8 weeks

  • Vascular Endothelial Function - Acute Response (Flow-Mediated Dilation)

    Baseline, 30 minutes, and 60 minutes post-exercise.

  • Cardiac Autonomic Modulation - Chronic (Heart Rate Variability)

    Baseline and 8 weeks.

  • +5 more secondary outcomes

Study Arms (4)

Dynamic strength training

EXPERIMENTAL

8 dynamic strength exercises, with 14 repetitions, 3 sets, 1 second concentric phase and 2 seconds eccentric phase. 30 seconds of rest between sets and 1 minute and 30 seconds of rest between exercises.

Other: Dynamic strength training

Isometric strength training

EXPERIMENTAL

8 isometric strength exercises. 10 seconds of isometric strength. 3 sets, 1 second concentric and 2 eccentric. 30 seconds rest between sets and 1 minute and 30 seconds rest between exercises.

Other: Acute Isometric Exercise Session.

Control group

EXPERIMENTAL

The control group consists of maintaining their habits for 8 weeks, without strength exercises.

Other: Control Session and Follow-up

Combined strength training

EXPERIMENTAL

8 resistance exercises combining dynamic repetitions with isometric components. Protocol: 3 sets of 11 repetitions, with a concentric phase of 1 second and an eccentric phase of 2 seconds combined with 10 seconds of isometric hold at the end of each set. Includes 30 seconds of rest between sets and 90 seconds between exercises.

Other: Combined strength training

Interventions

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.

Combined strength training

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.

Dynamic strength training

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

Isometric strength training

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.

Control group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of Stage 1 or 2 Hypertension (according to current guidelines). Sedentary (not engaged in structured exercise programs for at least 6 months). Aged between 18 and 60 years. Stable pharmacological treatment for at least 4 weeks. Ability to perform resistance exercises.

You may not qualify if:

  • Presence of symptomatic cardiovascular disease, heart failure, or unstable angina. Diagnosis of uncontrolled diabetes (HbA1c \> 8%) or renal failure. Musculoskeletal conditions or physical limitations that contraindicate resistance training. Recent changes in antihypertensive medication within the 4 weeks prior to or during the protocol. Current smoking or excessive alcohol consumption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Sul

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

Location

MeSH Terms

Conditions

Post-Exercise Hypotension

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
While it was not possible to mask the participants and the exercise instructors due to the nature of the training sessions, a clear separation was maintained between the team supervising the exercises and the team responsible for data collection and analysis. Specifically, the outcomes assessors responsible for the Ambulatory Blood Pressure Monitoring (ABPM) and Flow-Mediated Dilation (FMD) measurements were completely blinded to the participants' group allocation and had no involvement in the training protocols.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: "The study follows a sequential design divided into two distinct phases. In Phase 1 (Acute), a randomized crossover design is employed where all participants undergo four experimental sessions (Control, Dynamic Strength, Isometric Strength, and Combined Exercise) in a randomized order, with a minimum washout period of 48 to 72 hours between sessions to evaluate 24-hour post-exercise hypotension. In Phase 2 (Chronic), participants are then randomized into three parallel groups (Control, Dynamic Strength Training, and Combined Strength Training) for an 8-week intervention period. This phase aims to evaluate long-term cardiovascular adaptations, including 24-hour ambulatory blood pressure and endothelial function. Data collection for both phases has been completed."
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor at Universidade Federal do Rio Grande do Sul

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 13, 2026

Study Start

July 26, 2025

Primary Completion

December 23, 2025

Study Completion

December 23, 2025

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to ensure the privacy and confidentiality of the participants, in accordance with the local institutional review board and data protection regulations.

Locations