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

Primary Purpose

Arterial Stiffness, Hypertension, Cardiovascular Diseases

Status
Active
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Cardiovascular fitness
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Stiffness focused on measuring resistance training, arterial stiffness, hypertension, cardiovascular health

Eligibility Criteria

40 Years - 63 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Pavel Kolar´s Centre of Physical Medicine
  • The Faculty of Physical Education and Sport, Charles University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normotension group

Hypertension Stage 1 group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
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.
Body mass index
BMI (kg/m2 ) is measured by InBody370S. Optimal values for BMI: 18.5-24.9 kg
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.
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.
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.
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.
Fat mass
Fat mass (kg) is measured by InBody370S.
Lean mass
Lean mass (kg) is measured by InBody370S.
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.
Body weight
Body weight (kg) is measured by InBody370S.
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.
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.
The concentration of triacylglycerols
Triacylglycerols (mmol/l) are measured by NEXTCLINICS Czech a.s. The reference range is 0,45-1,70 mmol/l.
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.
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.

Full Information

First Posted
August 31, 2023
Last Updated
October 5, 2023
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT06047678
Brief Title
Acute Effect of Individual Variants of Agonist-antagonist and Traditional Agonistic Resistance Training on Cardiovascular Parameters
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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? Cardiovascular parameters Body composition Blood tests for heart disease Training intervention A. Resistance training protocol: 75% 1RM, 10 reps, 3 sets, 2 min rest between sets and exercises, 16 exercises Agonistic RT - upper body Agonistic RT - lower body Agonist-Antagonist - upper body Agonist-Antagonist - lower body B. Aerobic training: 60% SF max, 4 x 10 min, 2 min rest between sets Intraabdominal wall tension activity The Borg rating of perceived exertion Handgrip testing Repetition testing (RM)
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? Cardiovascular parameters - SBP, DBP, HR, PWV and augmentation index are measure by Arteriograph (TensioMed, Budapest, Hungary) at baseline, during and after training sessions. Body composition - Body composition is measured by InBody370S in Pavel Kolar´s Centre of Physical Medicine before intervention. 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 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 A. Resistance training protocol: Agonistic RT - upper body Agonistic RT - lower body Agonist-Antagonist - upper body Agonist-Antagonist - lower body B. Aerobic training: 60% SF max, 4 x 10 min, 2 min rest between sets 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. The intensity of the exercises is determined by the Borg rating of perceived exertion (RPE) during resistance training. Handgrip is measured by Takei (TKK 5401, Japan) before intervention. The Harvard Step Test is used to measure a clients aerobic fitness before intervention. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Stiffness, Hypertension, Cardiovascular Diseases
Keywords
resistance training, arterial stiffness, hypertension, cardiovascular health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparing two groups Normotensive group Hypertension Stage 1 group
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normotension group
Arm Type
Experimental
Arm Description
Participants with normotension Adult: 40 - 63 years old Physically active - no professional sportsman
Arm Title
Hypertension Stage 1 group
Arm Type
Experimental
Arm Description
Participants with Hypertension Stage 1 Adult: 40 - 63 years old Physically active - no professional sportsman.
Intervention Type
Behavioral
Intervention Name(s)
Cardiovascular fitness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Arterial stiffness - Pulse wave velocity
Description
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).
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.
Title
Blood pressure
Description
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).
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.
Secondary Outcome Measure Information:
Title
Handgrip strength
Description
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.
Time Frame
before intervention, one session, it takes 10 minutes, week 1
Title
The concentration of total cholesterol
Description
Total cholestero (mmol/l) is measured by NEXTCLINICS Czech a.s. The reference range is 2,90-5,00 mmol/l.
Time Frame
before intervention, one session, it takes 15 minutes, week 1
Title
Body mass index
Description
BMI (kg/m2 ) is measured by InBody370S. Optimal values for BMI: 18.5-24.9 kg
Time Frame
before intervention, one session, it takes 15 minutes, week 1
Title
Harvard step test
Description
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.
Time Frame
before intervention, one session, it takes 8 minutes, week 1
Title
Abdominal wall tension
Description
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.
Time Frame
two measurements, 2x 60-90 minutes, week 1
Title
The Borg rating of perceived exertion
Description
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.
Time Frame
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
Title
Repetition testing
Description
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.
Time Frame
two measurements, 2x 60-90 minutes, week 1
Title
Fat mass
Description
Fat mass (kg) is measured by InBody370S.
Time Frame
before intervention, one session, it takes 15 minutes, week 1
Title
Lean mass
Description
Lean mass (kg) is measured by InBody370S.
Time Frame
before intervention, one session, it takes 15 minutes, week 1
Title
Body fat
Description
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.
Time Frame
before intervention, one session, it takes 15 minutes, week 1
Title
Body weight
Description
Body weight (kg) is measured by InBody370S.
Time Frame
before intervention, one session, it takes 15 minutes, week 1
Title
The concentration of low density lipoprotein (LDL)
Description
LDL (mmol/l) is measured by NEXTCLINICS Czech a.s. The reference range is 1,2-3,00 mmol/l.
Time Frame
before intervention, one session, it takes 15 minutes, week 1
Title
The concentration of high density lipoprotein (HDL)
Description
HDL (mmol/l) is measured by NEXTCLINICS Czech a.s. The reference range is 1,00-2,10 mmol/l.
Time Frame
before intervention, one session, it takes 15 minutes, week 1
Title
The concentration of triacylglycerols
Description
Triacylglycerols (mmol/l) are measured by NEXTCLINICS Czech a.s. The reference range is 0,45-1,70 mmol/l.
Time Frame
before intervention, one session, it takes 15 minutes, week 1
Title
The concentration of c-reactive protein (CRP)
Description
CRP (mg/l) is measured by NEXTCLINICS Czech a.s. The reference range is 0,0-8,0 mmol/l.
Time Frame
before intervention, one session, it takes 15 minutes, week 1
Title
Blood sugar level
Description
Blood sugar (mmol/l) level is measured by NEXTCLINICS Czech a.s. The reference range is 3,30-5,59 mmol/l.
Time Frame
before intervention, one session, it takes 15 minutes, week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Pavel Kolar´s Centre of Physical Medicine
City
Prague
ZIP/Postal Code
148 00
Country
Czechia
Facility Name
The Faculty of Physical Education and Sport, Charles University
City
Prague
ZIP/Postal Code
162 52
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to the sensitivity of the data (personal data), it has not been decided whether the data will be provided to third parties.

Learn more about this trial

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

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