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

NCT05914870 | Completed

• 1 other identifier: UCMurcia-ETTH
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; High Blood Pressure; Training Program; Multicomponent Exercise; Combined Exercise; Cardiovascular Exercise

Outcome Measures

Primary Outcomes (1)

• Changes in Blood Pressure from baseline at week 12.

  Blood pressure (sytolic blood pressure and diastolic blood pressure) shall be assessed using the BPBIO-750 blood pressure monitor in millimetres of mercury (mmHg). The subject should sit down 5 minutes before the measurement to relax, without talking, with the back well positioned and without crossing the legs. After the 5 minutes of rest, proceed with the two programmed BP measurements, leaving 3 minutes between the two measurements

  Two times. Baseline and 12 weeks later

Secondary Outcomes (21)

• Changes in Mean Blood Pressure from baseline at week 12

  Two times. Baseline and 12 weeks later

• Changes in Pulse Pressure from baseline at week 12

  Two times. Baseline and 12 weeks later

• Changes in Dual Product from baseline at week 12

  Two times. Baseline and 12 weeks later

• Changes in Baseline Heart Rate from baseline at week 12

  Two times. Baseline and 12 weeks later

• Changes in weight from baseline at 12 weeks.

  Two times. Baseline and 12 weeks later

Study Arms (3)

Multi-component training

EXPERIMENTAL

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).

Other: Multi-component training

Continuous Cardiovascular Training

EXPERIMENTAL

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).

Other: Continuous Cardiovascular Training

Control Group

NO INTERVENTION

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

Interventions

Multi-component training 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.

Multi-component training

Continuous Cardiovascular Training 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.

Continuous Cardiovascular Training

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Noelia G González-Gálvez, PhD.

Murcia, 30010, Spain

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 22, 2023
• Study Start: June 20, 2023
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)