Acute and Chronic Effects of Combined Training on BP in Hypertensives
COMBAT-H
Acute And Chronic Effects Of Combined Strength Training On Regulatory Variables Of Ambulatory Blood Pressure In Medicated Hypertensive Patients
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2025
CompletedFirst Submitted
Initial submission to the registry
March 9, 2026
CompletedFirst Posted
Study publicly available on registry
March 13, 2026
CompletedMarch 13, 2026
March 1, 2026
5 months
March 9, 2026
March 9, 2026
Conditions
Keywords
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
EXPERIMENTAL8 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.
Isometric strength training
EXPERIMENTAL8 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.
Control group
EXPERIMENTALThe control group consists of maintaining their habits for 8 weeks, without strength exercises.
Combined strength training
EXPERIMENTAL8 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.
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.
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.
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
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- 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.