Clinical trial NCT05914870: Effects of Multicomponent Training Versus Cardiovascular Training as a Treatment for Hypertension in Adult Subjects
Official title: Effects of Multicomponent Training Versus Cardiovascular Training as a Treatment for Hypertension in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
High Blood Pressure
Training Program
Multicomponent Exercise
Combined Exercise
Cardiovascular Exercise
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in Blood Pressure from baseline at week 12.
timeFrame: Two times. Baseline and 12 weeks later
Secondary outcomes:
measure: Changes in Mean Blood Pressure from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Pulse Pressure from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Dual Product from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Baseline Heart Rate from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in weight from baseline at 12 weeks.
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Skeletal Muscle Mass from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Body Fat Mass from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Body Mass Index from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later].
measure: Changes in Body Fat Percentage from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Visceral Fat from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Phase Angle from Baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Waist circumference from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Total Cholesterol from Baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in HDL from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in LDL from baseline at one week
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Triglycerides from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Glucose from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Change in Manual Handgrip Strength from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Upper Body Strength from Baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Lower Body Strength from Baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
measure: Changes in Cardiorespiratory Capacity from baseline at week 12
timeFrame: Two times. Baseline and 12 weeks later
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Noelia G González-Gálvez, PhD.
Study officials:
References: