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

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06047678
• Other study ID #: CharlesUCRFTVS
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 63 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Stiffness
• Cardiovascular Diseases
• Hypertension

Intervention

Behavioral:
• Cardiovascular fitness
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.

Locations

Country	Name	City	State
Czechia	Pavel Kolar´s Centre of Physical Medicine	Prague
Czechia	The Faculty of Physical Education and Sport, Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	before intervention, one session, it takes 10 minutes, week 1
Secondary	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.	before intervention, one session, it takes 15 minutes, week 1
Secondary	Body mass index	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
Secondary	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.	before intervention, one session, it takes 8 minutes, week 1
Secondary	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.	two measurements, 2x 60-90 minutes, week 1
Secondary	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.	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
Secondary	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.	two measurements, 2x 60-90 minutes, week 1
Secondary	Fat mass	Fat mass (kg) is measured by InBody370S.	before intervention, one session, it takes 15 minutes, week 1
Secondary	Lean mass	Lean mass (kg) is measured by InBody370S.	before intervention, one session, it takes 15 minutes, week 1
Secondary	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.	before intervention, one session, it takes 15 minutes, week 1
Secondary	Body weight	Body weight (kg) is measured by InBody370S.	before intervention, one session, it takes 15 minutes, week 1
Secondary	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.	before intervention, one session, it takes 15 minutes, week 1
Secondary	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.	before intervention, one session, it takes 15 minutes, week 1
Secondary	The concentration of triacylglycerols	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
Secondary	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.	before intervention, one session, it takes 15 minutes, week 1
Secondary	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.	before intervention, one session, it takes 15 minutes, week 1