Clinical trial NCT06047678: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Arterial Stiffness
Hypertension
Cardiovascular Diseases
Keywords: resistance training
arterial stiffness
hypertension
cardiovascular health
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 47
Sex: ALL
Minimum age (years): 40
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing two groups

1. Normotensive group
2. Hypertension Stage 1 group
Primary purpose: TREATMENT

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. Cardiovascular parameters
2. Body composition
3. Blood tests for heart disease
4. Training intervention

A. Resistance training protocol: 75% 1RM, 10 reps, 3 sets, 2 min rest between sets and exercises, 16 exercises

1. Agonistic RT - upper body
2. Agonistic RT - lower body
3. Agonist-Antagonist - upper body
4. Agonist-Antagonist - lower body B. Aerobic training: 60% SF max, 4 x 10 min, 2 min rest between sets
5. Intraabdominal wall tension activity
6. The Borg rating of perceived exertion
7. Handgrip testing
8. 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?

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

A. Resistance training protocol:

1. Agonistic RT - upper body
2. Agonistic RT - lower body
3. Agonist-Antagonist - upper body
4. Agonist-Antagonist - lower body B. Aerobic training: 60% SF max, 4 x 10 min, 2 min rest between sets
5. 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.
6. The intensity of the exercises is determined by the Borg rating of perceived exertion (RPE) during resistance training.
7. Handgrip is measured by Takei (TKK 5401, Japan) before intervention. The Harvard Step Test is used to measure a clients aerobic fitness before intervention.
8. 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.

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

Primary outcomes:
measure: Arterial stiffness - Pulse wave velocity
timeFrame: 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.
measure: Blood pressure
timeFrame: 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:
measure: Handgrip strength
timeFrame: before intervention, one session, it takes 10 minutes, week 1
measure: The concentration of total cholesterol
timeFrame: before intervention, one session, it takes 15 minutes, week 1
measure: Body mass index
timeFrame: before intervention, one session, it takes 15 minutes, week 1
measure: Harvard step test
timeFrame: before intervention, one session, it takes 8 minutes, week 1
measure: Abdominal wall tension
timeFrame: two measurements, 2x 60-90 minutes, week 1
measure: The Borg rating of perceived exertion
timeFrame: 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
measure: Repetition testing
timeFrame: two measurements, 2x 60-90 minutes, week 1
measure: Fat mass
timeFrame: before intervention, one session, it takes 15 minutes, week 1
measure: Lean mass
timeFrame: before intervention, one session, it takes 15 minutes, week 1
measure: Body fat
timeFrame: before intervention, one session, it takes 15 minutes, week 1
measure: Body weight
timeFrame: before intervention, one session, it takes 15 minutes, week 1
measure: The concentration of low density lipoprotein (LDL)
timeFrame: before intervention, one session, it takes 15 minutes, week 1
measure: The concentration of high density lipoprotein (HDL)
timeFrame: before intervention, one session, it takes 15 minutes, week 1
measure: The concentration of triacylglycerols
timeFrame: before intervention, one session, it takes 15 minutes, week 1
measure: The concentration of c-reactive protein (CRP)
timeFrame: before intervention, one session, it takes 15 minutes, week 1
measure: Blood sugar level
timeFrame: before intervention, one session, it takes 15 minutes, week 1
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Pavel Kolar´s Centre of Physical Medicine
city: Prague
country: Czechia
facility: The Faculty of Physical Education and Sport, Charles University
Study officials:
References: