NCT06047678

Brief Summary

Prevention and non pharmacological treatment of prehypertension and hypertension stage 1 The effect of individual variants of agonist-antagonist and traditional agonistic resistance training on cardiovascular parameters in individuals with normotension and hypertension. What does the study involve?

  1. 1.Cardiovascular parameters
  2. 2.Body composition
  3. 3.Blood tests for heart disease
  4. 4.Training intervention
  5. 5.Agonistic RT - upper body
  6. 6.Agonistic RT - lower body
  7. 7.Agonist-Antagonist - upper body
  8. 8.Agonist-Antagonist - lower body B. Aerobic training: 60% SF max, 4 x 10 min, 2 min rest between sets
  9. 9.Intraabdominal wall tension activity
  10. 10.The Borg rating of perceived exertion
  11. 11.Handgrip testing
  12. 12.Repetition testing (RM)

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

April 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

1.4 years

First QC Date

August 31, 2023

Last Update Submit

February 5, 2024

Conditions

Keywords

resistance trainingarterial stiffnesshypertensioncardiovascular health

Outcome Measures

Primary Outcomes (2)

  • Arterial stiffness - Pulse wave velocity

    Specifically, Aortic pulse wave velocity will be measured. The norm is up to 9 m/s, values above 9 m/s indicate impaired arterial stiffness. Arterial stiffness is a growing epidemic associated with increased risk of cardiovascular events, dementia, and death. Decreased compliance of the central vasculature alters arterial pressure and flow dynamics and impacts cardiac performance and coronary perfusion. It is measured by Arteriograph (TensioMed, Budapest, Hungary).

    The training takes place twice a week, 1 training session takes 60 minutes, the total number of sessions is 5. The total length of the program is 3 weeks, duration is 5 hours.

  • Blood pressure

    Measurement of changes in blood pressure level. Increase in systolic and diastolic blood pressure (mm Hg) during resistance training for agonist-antagonist and traditional agonist resistance training. Blood pressure ranges: Normal: less than 120 systolic and 80 diastolic. Elevated: 120-129 systolic and less than 80 diastolic. Stage 1 hypertension: 130-139 systolic or 80-89 diastolic. Stage 2 hypertension: at least 140 systolic or at least 90 diastolic.Investigators are looking for the safest option of resistance training for individuals with hypertension. It is measured by Arteriograph (TensioMed, Budapest, Hungary).

    The training takes place twice a week, 1 training session takes 60 minutes, the total number of sessions is 5. The total length of the program is 3 weeks, duration is 5 hours.

Secondary Outcomes (16)

  • Handgrip strength

    before intervention, one session, it takes 10 minutes, week 1

  • The concentration of total cholesterol

    before intervention, one session, it takes 15 minutes, week 1

  • Body mass index

    before intervention, one session, it takes 15 minutes, week 1

  • Harvard step test

    before intervention, one session, it takes 8 minutes, week 1

  • Abdominal wall tension

    two measurements, 2x 60-90 minutes, week 1

  • +11 more secondary outcomes

Study Arms (2)

Normotension group

EXPERIMENTAL

Participants with normotension Adult: 40 - 63 years old Physically active - no professional sportsman

Behavioral: Cardiovascular fitness

Hypertension Stage 1 group

EXPERIMENTAL

Participants with Hypertension Stage 1 Adult: 40 - 63 years old Physically active - no professional sportsman.

Behavioral: Cardiovascular fitness

Interventions

A randomized single-blind controlled trial tested the hypothesis that different variants of resistance training (antagonistic lower and upper body training, agonistic lower and upper body training, and aerobic training) have different effects on blood pressure (systolic and diastolic), aortic pulse wave velocity (PWVao), and augmentation index (Aix) values and compared subjects with normotension and hypertension during and after exercise session.

Hypertension Stage 1 groupNormotension group

Eligibility Criteria

Age40 Years - 63 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • participants with normotension and clinical diagnosis of hypertension (1 stage of hypertension)
  • adult: 40 - 63 years old
  • physically active
  • capable of strength and aerobic training

You may not qualify if:

  • fluctuating blood pressure
  • type 1 and type 2 diabetes mellitus
  • after a myocardial infarction
  • after a stroke
  • with an infectious disease
  • with grade 3 obesity
  • hypertension II. - IV. degrees
  • suffering from dizziness during exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pavel Kolar´s Centre of Physical Medicine

Prague, 148 00, Czechia

Location

The Faculty of Physical Education and Sport, Charles University

Prague, 162 52, Czechia

Location

Related Publications (1)

  • Jurik R, Stastny P, Kolinger D, Gola A, Vetrovsky T. Blood pressure changes during different methods of resistance training in normotensive and stage 1 hypertensive individuals: a repeated measures cross-sectional study. BMC Sports Sci Med Rehabil. 2025 Mar 14;17(1):49. doi: 10.1186/s13102-025-01097-3.

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparing two groups 1. Normotensive group 2. Hypertension Stage 1 group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 21, 2023

Study Start

April 1, 2022

Primary Completion

August 31, 2023

Study Completion

December 31, 2024

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Due to the sensitivity of the data (personal data), it has not been decided whether the data will be provided to third parties.

Locations