- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06047678
Acute Effect of Individual Variants of Agonist-antagonist and Traditional Agonistic Resistance Training on Cardiovascular Parameters
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.
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)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Prague, Czechia, 148 00
- Pavel Kolar´s Centre of Physical Medicine
-
Prague, Czechia, 162 52
- The Faculty of Physical Education and Sport, Charles University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Normotension group
Participants with normotension Adult: 40 - 63 years old Physically active - no professional sportsman
|
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.
|
|
Experimental: Hypertension Stage 1 group
Participants with Hypertension Stage 1 Adult: 40 - 63 years old Physically active - no professional sportsman.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Borg rating of perceived 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
|
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.
|
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
|
|
Handgrip strength
Time Frame: before intervention, one session, it takes 10 minutes, week 1
|
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.
|
before intervention, one session, it takes 10 minutes, week 1
|
|
The concentration of total cholesterol
Time Frame: before intervention, one session, it takes 15 minutes, week 1
|
Total cholestero (mmol/l) is measured by NEXTCLINICS Czech a.s.
The reference range is 2,90-5,00 mmol/l.
|
before intervention, one session, it takes 15 minutes, week 1
|
|
Body mass index
Time Frame: before intervention, one session, it takes 15 minutes, week 1
|
BMI (kg/m2 ) is measured by InBody370S.
Optimal values for BMI: 18.5-24.9
kg
|
before intervention, one session, it takes 15 minutes, week 1
|
|
Harvard step test
Time Frame: before intervention, one session, it takes 8 minutes, week 1
|
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.
|
before intervention, one session, it takes 8 minutes, week 1
|
|
Abdominal wall tension
Time Frame: two measurements, 2x 60-90 minutes, week 1
|
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.
|
two measurements, 2x 60-90 minutes, week 1
|
|
Repetition testing
Time Frame: two measurements, 2x 60-90 minutes, week 1
|
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.
|
two measurements, 2x 60-90 minutes, week 1
|
|
Fat mass
Time Frame: before intervention, one session, it takes 15 minutes, week 1
|
Fat mass (kg) is measured by InBody370S.
|
before intervention, one session, it takes 15 minutes, week 1
|
|
Lean mass
Time Frame: before intervention, one session, it takes 15 minutes, week 1
|
Lean mass (kg) is measured by InBody370S.
|
before intervention, one session, it takes 15 minutes, week 1
|
|
Body fat
Time Frame: before intervention, one session, it takes 15 minutes, week 1
|
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.
|
before intervention, one session, it takes 15 minutes, week 1
|
|
Body weight
Time Frame: before intervention, one session, it takes 15 minutes, week 1
|
Body weight (kg) is measured by InBody370S.
|
before intervention, one session, it takes 15 minutes, week 1
|
|
The concentration of low density lipoprotein (LDL)
Time Frame: before intervention, one session, it takes 15 minutes, week 1
|
LDL (mmol/l) is measured by NEXTCLINICS Czech a.s.
The reference range is 1,2-3,00 mmol/l.
|
before intervention, one session, it takes 15 minutes, week 1
|
|
The concentration of high density lipoprotein (HDL)
Time Frame: before intervention, one session, it takes 15 minutes, week 1
|
HDL (mmol/l) is measured by NEXTCLINICS Czech a.s.
The reference range is 1,00-2,10 mmol/l.
|
before intervention, one session, it takes 15 minutes, week 1
|
|
The concentration of triacylglycerols
Time Frame: before intervention, one session, it takes 15 minutes, week 1
|
Triacylglycerols (mmol/l) are measured by NEXTCLINICS Czech a.s.
The reference range is 0,45-1,70 mmol/l.
|
before intervention, one session, it takes 15 minutes, week 1
|
|
The concentration of c-reactive protein (CRP)
Time Frame: before intervention, one session, it takes 15 minutes, week 1
|
CRP (mg/l) is measured by NEXTCLINICS Czech a.s.
The reference range is 0,0-8,0 mmol/l.
|
before intervention, one session, it takes 15 minutes, week 1
|
|
Blood sugar level
Time Frame: before intervention, one session, it takes 15 minutes, week 1
|
Blood sugar (mmol/l) level is measured by NEXTCLINICS Czech a.s.
The reference range is 3,30-5,59 mmol/l.
|
before intervention, one session, it takes 15 minutes, week 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CharlesUCRFTVS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Hull University Teaching Hospitals NHS TrustNot yet recruitingCardiovascular Surgery | Cardiovascular Diseases (CVD)United Kingdom
-
Weill Medical College of Cornell UniversityAmerican Heart AssociationRecruitingCardiovascular | Cardiovascular Health | Cardiovascular (CV) Risk | Cardiovascular Disease (CVD) Risk FactorsUnited States
-
Fu Jen Catholic UniversityRecruitingCardiovascular Disease | Cardiovascular SurgeryTaiwan
-
Medical College of WisconsinNational Center for Complementary and Integrative Health (NCCIH)CompletedCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
IRCCS Policlinico S. DonatoIRCCS San Raffaele; Fondazione Policlinico Universitario Agostino Gemelli IRCCS and other collaboratorsRecruitingCardiovascular Risk | Genetic Cardiovascular RiskItaly
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
Children's Hospital Medical Center, CincinnatiRecruitingCardiovascular Diseases (CVD)United States
Clinical Trials on Cardiovascular fitness
-
University of ZurichFederal Office of Sports, Switzerland; Swiss Ankylosing Spondylitis AssociationCompletedAnkylosing SpondylitisSwitzerland
-
Vastra Gotaland RegionTerminatedRefractory EpilepsySweden
-
University of WashingtonCenters for Disease Control and PreventionRecruitingArthritis | Osteoarthritis | Rheumatoid Arthritis | Fibromyalgia | Gout | Lupus or SLEUnited States
-
Mike O'Callaghan Military HospitalCompletedType II Diabetes MellitusUnited States
-
Colorado State UniversityCompleted
-
University of AarhusCentral Denmark Region; TRYG Foundation; Randers Municipality, DenmarkCompletedPhysical Activity | Health Behavior | Motivation | Cardiorespiratory Fitness | IntentionDenmark
-
University of MichiganAmerican Diabetes AssociationCompletedMetabolic SyndromeUnited States
-
University Hospital TuebingenUnknownCancer | Fatigue | Physical ActivityGermany
-
University of PennsylvaniaCompleted