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Arterial StiffnessNCT06047678

Acute Effect of Individual Variants of Agonist-antagonist and Traditional Agonistic Resistance Training on Cardiovascular Parameters

A study testing Cardiovascular fitness in people with Arterial Stiffness and Hypertension, run by Charles University, Czech Republic at 2 sites in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 63 yearsHealthy volunteers can take part
What is being tested?
Cardiovascular fitness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
2 sitesCzechia
Study dates
1 Apr 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 63 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Czechia2 sites
  • Pavel Kolar´s Centre of Physical Medicine

    Prague, 148 00

  • The Faculty of Physical Education and Sport, Charles University

    Prague, 162 52

Other trials in Czechia

About this study

Official title: Acute Effect of Individual Variants of Agonist-antagonist and Traditional Agonistic Resistance Training on Cardiovascular Parameters in Patients With Normotension and 1 Stage of Hypertension.

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.

Read more

What does the study involve?

  1. Cardiovascular parameters
  2. Body composition
  3. Blood tests for heart disease
  4. Training intervention
  5. Resistance training protocol: 75% 1RM, 10 reps, 3 sets, 2 min rest between sets and exercises, 16 exercises
  6. Agonistic RT - upper body
  7. Agonistic RT - lower body
  8. Agonist-Antagonist - upper body
  9. Agonist-Antagonist - lower body B. Aerobic training: 60% SF max, 4 x 10 min, 2 min rest between sets
  10. Intraabdominal wall tension activity
  11. The Borg rating of perceived exertion
  12. Handgrip testing
  13. Repetition testing (RM)
Read the detailed description

The effect of individual variants of agonist-antagonist and traditional agonistic resistance training on cardiovascular parameters in individuals with normotension and hypertension.

Participants with normotension and hypertension (1 stage of hypertension), adult: 40 - 63 years old, physically active - no professional sportsman.

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

What does the study involve?

  1. Cardiovascular parameters - SBP, DBP, HR, PWV and augmentation index are measure by Arteriograph (TensioMed, Budapest, Hungary) at baseline, during and after training sessions.
  2. Body composition - Body composition is measured by InBody370S in Pavel Kolar´s Centre of Physical Medicine before intervention.
  3. Blood tests for heart disease - tests help determine the risk of heart diseases. it can be very helpful in assessing health. Total cholesterol, LDL, HDL, triacylglycerols, CRP, glucose are measured by NEXTCLINICS Czech a.s. before intervention
  4. Training intervention: Resistance training: 75% 1RM, 10 reps, 3 sets, 2 min rest between sets and exercises, 16 exercises (8 lower body exercise + 8 upper body exercise), Agonistic vs Agonistic-antagonist resistance training, freeweight + cable machines according to ACSM's Guidelines for Exercise Testing and Prescription, 11th Edition
  5. Resistance training protocol:
  6. Agonistic RT - upper body
  7. Agonistic RT - lower body
  8. Agonist-Antagonist - upper body
  9. Agonist-Antagonist - lower body B. Aerobic training: 60% SF max, 4 x 10 min, 2 min rest between sets
  10. Intraabdominal wall tension testing during resistance training - correction of respiratory stereotype during exercise. Abdominal wall tension is measured by OHMBelt (Nilus Medical LLC) in Pavel Kolar´s Centre of Physical Medicine before, during and after resistance training.
  11. The intensity of the exercises is determined by the Borg rating of perceived exertion (RPE) during resistance training.
  12. Handgrip is measured by Takei (TKK 5401, Japan) before intervention. The Harvard Step Test is used to measure a clients aerobic fitness before intervention.
  13. Repetition testing is assessing the strength capacity of individuals in non-laboratory environments: 15 RM, 10RM, 5 RM, 1 RM tests in Pavel Kolar´s Centre of Physical Medicine and the Faculty of Physical Education and Sport, Charles University before intervention.

Benefits: health assessment, physical fitness testing, professional supervision of training.

Potential disadvantages: soreness and muscle strain, fatigue, dizziness, feeling sick.

The study is run in Pavel Kolar´s Centre of Physical Medicine and the Faculty of Physical Education and Sport, Charles University.

The study began in April 2022 and will run until December 31, 2023. Agonist-Antagonist resistance training with 75% 1 RM induces an similar decrease in systolic and diastolic blood pressure values after training sessions at the p<0.05 level, as aerobic (control) training in normotensive and hypertensive individuals (1 stage of hypertension).

Alternative hypothesis H1: Agonistic-Antagonist resistance training with 75% 1 RM will result in a smaller increase in systolic and diastolic blood pressure values after training sessions at the p<0.05 level, compared to traditional resistance training in sets in normotensive and hypertensive subjects (1 stage of hypertension).

Agonistic resistance training with 75% 1 RM will induce a similar increase in pulse wave velocity during the training sessions at the p <0.05 level as aerobic (control) training in normotensive and hypertensive subjects (1 stage of hypertension).

Alternative Hypothesis H2: Agonistic resistance training with 75% 1 RM will result in a statistically significantly greater increase in pulse wave velocity values during the training sessions at the p <0.05 level compared to traditional resistance training in sets in normotensive and hypertensive subjects (1 stage of hypertension).

Isolated exercises induce a similar increase in systolic and diastolic blood pressure values during resistance training in normotensive and hypertensive individuals (1 stage of hypertension) as aerobic (control) training.

Alternative hypothesis H3: Complex/multi-joint exercises will lead to statistically significantly higher increases in systolic and diastolic blood pressure values in normotensive and hypertensive subjects (1 stage of hypertension) compared to isolated exercises.

Being tested
Cardiovascular fitness
Keywords
resistance training, arterial stiffness, hypertension, cardiovascular health
Medical subject headings
Hypertension, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiovascular fitnessBehavioural

    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.

Study groups in NCT06047678
Study groupRoleWhat they receive
Normotension groupExperimentalParticipants with normotension Adult: 40 - 63 years old Physically active - no professional sportsman
Receives: Behavioral: Cardiovascular fitness
Hypertension Stage 1 groupExperimentalParticipants with Hypertension Stage 1 Adult: 40 - 63 years old Physically active - no professional sportsman.
Receives: Behavioral: Cardiovascular fitness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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.

  2. 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).

    Measured: 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)
  1. Handgrip strength

    Handgrip (kg) is measured by Takei (TKK 5401, Japan).It will be measured for both hands (left and right). Three trials will be performed on each hand and the mean will be calculated. The standard for men over 40 years of age is 47 (±9.5) kg for the right hand and 45 (±9.3) kg for the left hand. The standard for women over 40 is 29 (±5.7) kg for the right hand and 28 (±5.7) kg for the left hand. Higher values are considered to be better.

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

  2. The concentration of total cholesterol

    Total cholestero (mmol/l) is measured by NEXTCLINICS Czech a.s. The reference range is 2,90-5,00 mmol/l.

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

  3. Body mass index

    BMI (kg/m2 ) is measured by InBody370S. Optimal values for BMI: 18.5-24.9 kg

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

  4. Harvard step test

    The Harvard Step Test is used to measure a clients aerobic fitness, being a predictive test of their VO2max. It tests the cardiovascular system and reflects the general capacity of body to cope with increased physical work load and ability to recover from it. Values in steptest for untrained population: > 90 points: excellent, 80-89 points: good, < 65 - 79 points: average, 55 - 64 points: Poor, 65 - 79: low average. Higher values mean a better result.

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

  5. Abdominal wall tension

    Abdominal wall tension is measured by OHMBelt (Nilus Medical LLC) . Increases in abdominal wall tension correlate with intra-abdominal pressure changes. It could be an approximate predictor of systolic blood pressure.

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

  6. The Borg rating of perceived exertion

    A modified Borg CR10 Scale will be used in this study. The subject will indicate the intensity of the exercise on a scale from 0 to 10. 0 means no exertion and 10 means maximum exertion.

    Measured: The total length of the program is 3 weeks, total duration is 5 hours. The results are recorded after each series of exercises - total 8x

  7. Repetition testing

    Assessing the strength capacity of individuals in non-laboratory environments. It is simply defined as the maximal or submacimal weight an individual can lift for only one repetition with correct technique. We measured 15 RM, 10 RM, 5 RM, 5 RM and 1RM in normotensive individuals.

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

  8. Fat mass

    Fat mass (kg) is measured by InBody370S.

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

  9. Lean mass

    Lean mass (kg) is measured by InBody370S.

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

  10. Body fat

    Body fat (%) is measured by InBody370S. Optimal values for % body fat: age 40-59 - 23-33% body fat, age 60-79 - 24-35% body fat.

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

  11. Body weight

    Body weight (kg) is measured by InBody370S.

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

  12. The concentration of low density lipoprotein (LDL)

    LDL (mmol/l) is measured by NEXTCLINICS Czech a.s. The reference range is 1,2-3,00 mmol/l.

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

  13. The concentration of high density lipoprotein (HDL)

    HDL (mmol/l) is measured by NEXTCLINICS Czech a.s. The reference range is 1,00-2,10 mmol/l.

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

  14. The concentration of triacylglycerols

    Triacylglycerols (mmol/l) are measured by NEXTCLINICS Czech a.s. The reference range is 0,45-1,70 mmol/l.

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

  15. The concentration of c-reactive protein (CRP)

    CRP (mg/l) is measured by NEXTCLINICS Czech a.s. The reference range is 0,0-8,0 mmol/l.

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

  16. Blood sugar level

    Blood sugar (mmol/l) level is measured by NEXTCLINICS Czech a.s. The reference range is 3,30-5,59 mmol/l.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start1 Apr 2022
  3. Primary completion31 Aug 2023
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparing two groups 1. Normotensive group 2. Hypertension Stage 1 group
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047678
Sponsor's protocol ID
CharlesUCRFTVS
Status last verified
Feb 2024
First submitted
31 Aug 2023
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to the sensitivity of the data (personal data), it has not been decided whether the data will be provided to third parties.

Publications

  • 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.

    PubMed 40087719

Questions about this trial

What is this clinical trial studying?

A study testing Cardiovascular fitness in people with Arterial Stiffness and Hypertension, run by Charles University, Czech Republic at 2 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arterial stiffness - Pulse wave velocity (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06047678, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.

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