Effects of Multicomponent Training Versus Cardiovascular Training as a Treatment for Hypertension in Adult Subjects

NCT ID: NCT05914870

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2023-09-29

Brief Summary

Hypertension is the most prevalent risk factor and the third leading cause of death worldwide, responsible for an increase in cardiac events. International guidelines on cardiology and hypertension recommend the practice of regular physical exercise for the control and treatment of this disease. The main objective of the study will be to determine the effect of a Multicomponent Training programme versus a Cardiovascular Training programme on blood pressure levels in hypertensive adults. The work methodology will consist of a controlled, randomised, longitudinal and prospective clinical trial, with several simultaneous study branches; on the one hand, the interventions with Multicomponent Training; on the other hand, the interventions with Cardiovascular Training; and, finally, a control group. The sample will be composed of 75 adult hypertensive subjects, including men and women, divided into groups of 25 people, two intervention groups and one control group. The inclusion criteria will be adult subjects, aged 40-65 years, with controlled arterial hypertension and sedentary. Exclusion criteria will be pregnant women and hypertensive patients with serious diseases that prevent the safe practice of physical exercise. The intervention will last 12 weeks and training will be 2 days per week, 60 minutes per session. The variables of the pre-post intervention study will be haemodynamic parameters; body composition, abdominal perimeter, general and manual strength, cardiorespiratory capacity, lipid profile and glucose.

Detailed Description

Cardiovascular disease is the leading cause of premature death worldwide and hypertension (HTN) is the most prevalent cardiovascular risk factor, being the third leading cause of death worldwide and responsible for an increased risk of heart disease, encephalopathy and kidney disease. HTN tops the list of serious non-communicable diseases, accounting for 10.4 million deaths per year. International guidelines on HTN recommend a diagnosis of HTN when a person's systolic blood pressure (SBP) in consultation is ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg, after several measurements (at least 3 every 1-2 minutes) on different days have been taken and recorded. Non-pharmacological interventions should be key to the control and treatment of HTN; these interventions involve changes in habits and behaviours in daily life, and it is here where the practice of regular physical exercise is decisive. The main objective of the study will be to analyse and compare the effect of a Multi-Component Training (MCT) programme versus a Continuous Cardiovascular Training (CVT) programme on BP levels in adult hypertensive subjects. The working methodology will consist of a controlled, randomised, longitudinal and prospective clinical trial, with several simultaneous study branches; on the one hand, the intervention with Multicomponent Training; on the other hand, the intervention Continuous Training and, finally, the control group. The recruitment of the sample will be done in collaboration with the primary health care centres in order to recruit a total of 75 adult hypertensive subjects between men and women who will be divided into three groups of 25 people each, two intervention groups and one control group. The inclusion criteria for participation in the clinical trial will be adult subjects, between 40 and 65 years of age, with controlled arterial hypertension and who do not do physical exercise or have not done so in the last 12 months. Exclusion criteria will be pregnant women and hypertensive patients with serious diseases that prevent the safe practice of physical exercise (unstable coronary artery disease, heart failure, renal failure, severe pulmonary hypertension, uncontrolled diabetes). The intervention will consist of two different training programmes, one with EMC and one with ECVC, for 12 weeks (3 months), with a frequency of 2 days a week and a duration of 60 minutes per session. During this period of time, the different phases of the design of the training programmes will be exhaustively defined, from the planning phase, with the anamnesis of the subject, through the periodisation phase, where the mesocycles, microcycles, training sessions and training units will be organised, the programming phase, controlling and manipulating the operative variables of frequency, volume, intensity and density, until reaching the last phase of the process, which will be the training prescription phase, with the work methodology and the selection of exercises. The EMC programme will involve applying two main intra-session and daily training units, a first part focused on strength work and a second part for cardiovascular training. This group will train 60 minutes per session, 10 minutes for the preparatory phase to exercise, 40 minutes for the main phase of the training, 20 minutes of strength work and 20 minutes of cardiovascular work, and finally 10 minutes for the post-exercise phase. The ECVC programme will involve a single main training unit per session per day; in this intervention the training will be exclusively cardiovascular. This group will train 60 minutes per session, 10 minutes for the preparatory phase to exercise, 40 minutes for the main phase of training and, finally, 10 minutes for the post-exercise phase. The study variables and the instruments for the assessment of these variables pre-post intervention will be systolic and diastolic blood pressure, mean arterial blood pressure, pulse pressure, double product and basal heart rate which will be measured with the BPBIO-750 sphygmomanometer; body composition analysis (weight, musculoskeletal mass, fat mass and visceral fat area) and phase angle will be analysed with the InBody 770; abdominal perimeter will be measured with a tape measure; manual strength will be assessed with a Baseline hydraulic dynamometer and upper and lower body strength will be measured through execution speed with a progressive load test, bench press and squat respectively, for the estimation of 1RM; cardiorespiratory capacity will be assessed with a clinical test on a cycloergometer; lipid profile values (cholesterol, HDL, LDL, triglycerides) and glucose will be obtained with a blood biochemistry.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Multi-component training

The Multicomponent Training programme will apply two main training units per session per day.

This experimental group will perform 2 intervention sessions per week with a duration of 60 minutes each; 10 minutes for the preparatory phase to exercise in which they will perform joint mobility exercises and dynamic stretching; 40 minutes will be dedicated to the main phase of the training, 20 minutes for strength work, with two exercises, one for the upper body and one for the lower body, and 20 minutes for cardiovascular work; finally, 10 minutes for the post-exercise phase in which they will perform a return to calm and static stretching.

The duration of the programme will be 12 weeks (3 months).

Group Type: EXPERIMENTAL

Multi-component training

Intervention Type: OTHER

The multicomponent training group will perform 60 minutes of training per session:

• 10 minutes of joint mobility exercises and dynamic stretching.
• 20 minutes of strength work with 2 exercises; the first, bench press, at an intensity of 50% of your 1RM. The number of repetitions will be individualised for each subject by testing the loss of speed in the series with respect to the first repetition (15% loss); the second, the squat, at an intensity of 60% of your 1RM. The number of repetitions shall be individualised for each subject by means of the loss of speed test in the series with respect to the first repetition (10% loss). The rest between sets will be 3 minutes.
• 20 minutes of continuous cardiovascular work. The intensity will be increased every 4 weeks, from week 1 to 4 between 55%-65%FCR or VO2peak, from week 5 to 8 between 65%-%75%FCR or VO2peak and from week 9 to 12 between 75%-%85%FCR or VO2peak.
• 10 minutes of cool down and static stretching.

Continuous Cardiovascular Training

The Continuous Cardiovascular Training programme will apply a single main training unit per session per day.

This experimental group will perform 2 intervention sessions per week with a duration of 60 minutes each; 10 minutes for the preparatory phase to exercise in which they will perform joint mobility exercises and dynamic stretching; 40 minutes for the main phase of the training where they will perform continuous aerobic work without changes in intensity during the session; finally, 10 minutes for the post-exercise phase in which they will perform a return to calm and static stretching.

The duration of the programme is 12 weeks (3 months).

Group Type: EXPERIMENTAL

Continuous Cardiovascular Training

Intervention Type: OTHER

The Continuous Cardiovascular Training group will perform 60 minutes of training per session distributed as follows:

Preparatory Phase: 10 minutes of standardised warm-up with joint mobility exercises and dynamic stretching.

Main Training Phase:

In this phase we will work 40 minutes of continuous aerobic exercise, maintaining the same intensity range throughout the session. We will increase the intensity every 4 weeks, from 1 to 4 you will work between 55%-65%FCR or VO2peak, from 5 to 8 between 65%-%75%FCR or VO2peak and from 9 to 12 between 75%-%85%FCR or VO2peak.

Post-training phase: 10' cool down and static stretching.

Control Group

The control group will not perform any physical exercise programme and will continue with their daily tasks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multi-component training

The multicomponent training group will perform 60 minutes of training per session:

• 10 minutes of joint mobility exercises and dynamic stretching.
• 20 minutes of strength work with 2 exercises; the first, bench press, at an intensity of 50% of your 1RM. The number of repetitions will be individualised for each subject by testing the loss of speed in the series with respect to the first repetition (15% loss); the second, the squat, at an intensity of 60% of your 1RM. The number of repetitions shall be individualised for each subject by means of the loss of speed test in the series with respect to the first repetition (10% loss). The rest between sets will be 3 minutes.
• 20 minutes of continuous cardiovascular work. The intensity will be increased every 4 weeks, from week 1 to 4 between 55%-65%FCR or VO2peak, from week 5 to 8 between 65%-%75%FCR or VO2peak and from week 9 to 12 between 75%-%85%FCR or VO2peak.
• 10 minutes of cool down and static stretching.

Intervention Type: OTHER

Continuous Cardiovascular Training

The Continuous Cardiovascular Training group will perform 60 minutes of training per session distributed as follows:

Preparatory Phase: 10 minutes of standardised warm-up with joint mobility exercises and dynamic stretching.

Main Training Phase:

In this phase we will work 40 minutes of continuous aerobic exercise, maintaining the same intensity range throughout the session. We will increase the intensity every 4 weeks, from 1 to 4 you will work between 55%-65%FCR or VO2peak, from 5 to 8 between 65%-%75%FCR or VO2peak and from 9 to 12 between 75%-%85%FCR or VO2peak.

Post-training phase: 10' cool down and static stretching.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults aged 40-65 years
• Controlled high blood pressure
• Sedentary

Exclusion Criteria

• Pregnant women
• Hypertensive patients with serious diseases that prevent safe physical activity

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Noelia González-Gálvez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Noelia G González-Gálvez, PhD.

Murcia, , Spain

Countries

Spain

Other Identifiers

UCMurcia-ETTH

Identifier Type: -

Identifier Source: org_study_id