HypertensionETTHNCT05914870
Effects of Multicomponent Training Versus Cardiovascular Training as a Treatment for Hypertension in Adult Subjects
A study testing Multi-component training and Continuous Cardiovascular Training in people with Hypertension, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Multi-component training and Continuous Cardiovascular Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jun 2023to 29 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 40-65 years
- Controlled high blood pressure
- Sedentary
Who cannot join
- Pregnant women
- Hypertensive patients with serious diseases that prevent safe physical activity
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Multi-component training, Continuous Cardiovascular Training
- Keywords
- Hypertension, High Blood Pressure, Training Program, Multicomponent Exercise, Combined Exercise, Cardiovascular Exercise
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component trainingOther
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 TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two times. Baseline and 12 weeks later
Secondary outcomes (21)
Changes in Mean Blood Pressure from baseline at week 12
Mean Blood Pressure will be assessed by BPBIO-750 sphygmomanometer in millimetres of mercury (mmHg)
Measured: Two times. Baseline and 12 weeks later
Changes in Pulse Pressure from baseline at week 12
Pulse Pressure shall be assessed by BPBIO-750 sphygmomanometer in millimetres of mercury (mmHg).
Measured: Two times. Baseline and 12 weeks later
Changes in Dual Product from baseline at week 12
The Dual Product will be assessed using the BPBIO-750 sphygmomanometer in millimetres of mercury (mmHg).
Measured: Two times. Baseline and 12 weeks later
Changes in Baseline Heart Rate from baseline at week 12
Baseline heart rate shall be assessed by BPBIO-750 sphygmomanometer in millimetres of mercury (mmHg).
Measured: Two times. Baseline and 12 weeks later
Changes in weight from baseline at 12 weeks.
Weight will be assessed by bioimpedance with the DSM-BIA Multifrequency Segmental Segmental Body Composition Analyser InBody 770. For the assessment, subjects will be informed that they must have spent at least 3 hours since the last meal and 30 minutes without drinking; not have drunk alcohol in the previous 48 hours; go to the toilet 30 minutes before weighing and not wear metal items in contact with the skin such as rings, bracelets or watches.
Measured: Two times. Baseline and 12 weeks later
Changes in Skeletal Muscle Mass from baseline at week 12
Skeletal Muscle Mass shall be assessed by bioimpedance with the DSM-BIA Multifrequency Segmental Segmental Body Composition Analyser InBody 770
Measured: Two times. Baseline and 12 weeks later
Changes in Body Fat Mass from baseline at week 12
Body Fat Mass will be assessed by bioimpedance with the DSM-BIA Multifrequency Segmental Segmental Body Composition Analyser InBody 770.
Measured: Two times. Baseline and 12 weeks later
Changes in Body Mass Index from baseline at week 12
BMI will be assessed by bioimpedance with the DSM-BIA Multifrequency Segmental Body Composition Analyser InBody 770.
Measured: Two times. Baseline and 12 weeks later].
Changes in Body Fat Percentage from baseline at week 12
Body Fat Percentage will be assessed by bioimpedance with the DSM-BIA Multifrequency Segmental Body Composition Analyser InBody 770.
Measured: Two times. Baseline and 12 weeks later
Changes in Visceral Fat from baseline at week 12
Visceral Fat will be assessed by bioimpedance with the InBody 770 DSM-BIA Multifrequency Segmental Segmental Body Composition Analyser.
Measured: Two times. Baseline and 12 weeks later
Changes in Phase Angle from Baseline at week 12
Phase Angle will be assessed by bioimpedance with the DSM-BIA Multifrequency Segmental Body Composition Analyser InBody 770.
Measured: Two times. Baseline and 12 weeks later
Changes in Waist circumference from baseline at week 12
Waist circumference will be assessed according to the ISAK protocol, using a tape measure and recorded in centimetres (cm). The subject should stand with feet together, arms crossed over the chest and abdomen relaxed; the measurement will be taken at the narrowest point of the waist, between the 10th rib and the iliac crest, the subject will be asked to lower the arms to the sides of the body and will be measured at the end of a normal exhalation.
Measured: Two times. Baseline and 12 weeks later
Changes in Total Cholesterol from Baseline at week 12
Total Cholesterol will be assessed by blood biochemistry. It will be recorded in milligrams decilitres (mg/dl). To perform the blood biochemistry the subject must have been fasting for at least 6 hours.
Measured: Two times. Baseline and 12 weeks later
Changes in HDL from baseline at week 12
High density lipoproteins will be assessed by blood biochemistry. To be recorded in milligrams decilitres (mg/dl).
Measured: Two times. Baseline and 12 weeks later
Changes in LDL from baseline at one week
Low density lipoproteins will be assessed by blood biochemistry. To be recorded in milligrams decilitres (mg/dl).
Measured: Two times. Baseline and 12 weeks later
Changes in Triglycerides from baseline at week 12
Triglycerides shall be assessed by blood biochemistry. It shall be recorded in milligrams decilitres (mg/dl).
Measured: Two times. Baseline and 12 weeks later
Changes in Glucose from baseline at week 12
Glucose will be assessed by blood biochemistry. It will be recorded in milligrams decilitres (mg/dl).
Measured: Two times. Baseline and 12 weeks later
Change in Manual Handgrip Strength from baseline at week 12
Manual Handgrip Strength will be assessed using a Baseline hand-held hydraulic dynamometer. It shall be recorded in kilograms (kg). For the measurement, the subject should sit in the chair, with the back supported by the backrest, feet flat on the floor and with the right elbow flexed at 90º; place the wrist in a neutral position with the thumb upwards gripping the dynamometer; the subject should squeeze with the greatest possible force and pressure. The same shall be repeated with the left hand. Two measurements shall be made with both hands.
Measured: Two times. Baseline and 12 weeks later
Changes in Upper Body Strength from Baseline at week 12
Upper body strength will be assessed with a progressive load test through running speed. It will be recorded in metres per second (m/s). The test will be performed with a bench press to estimate the1RM. It will be recorded in kilograms.
Measured: Two times. Baseline and 12 weeks later
Changes in Lower Body Strength from Baseline at week 12
Lower body strength will be assessed with a progressive load test through running speed. It will be recorded in metres per second (m/s). The test will be performed with a squat to estimate 1RM. It will be recorded in kilograms.
Measured: Two times. Baseline and 12 weeks later
Changes in Cardiorespiratory Capacity from baseline at week 12
Cardiorespiratory fitness will be assessed with a clinical test on a cycloergometer. It will be a step test, 2 minutes each step. The first 2 minutes will be performed without load and from that moment the test will begin with 2 minutes at 50w. This will be increased by 25w every 2 minutes until the subject reaches voluntary fatigue. VO2peak will be recorded.
Measured: Two times. Baseline and 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start20 Jun 2023
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noelia González-Gálvez, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914870
- Sponsor's protocol ID
- UCMurcia-ETTH
- Acronym
- ETTH
- Status last verified
- May 2024
- First submitted
- 5 Jun 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multicomponent Training Versus Cardiovascular Training as a Treatment for Hypertension in Adult Subjects
- ClinicalTrials.gov ID
- NCT05914870
- Acronym / sponsor ID
- ETTH / UCMurcia-ETTH
- Conditions
- Hypertension
- Keywords
- Hypertension, High Blood Pressure, Training Program, Multicomponent Exercise, Combined Exercise, Cardiovascular Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multi-component training | Experimental | Other: Multi-component trainingThe 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). |
| Continuous Cardiovascular Training | Experimental | Other: Continuous Cardiovascular TrainingThe 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). |
| Control Group | No intervention | –The control group will not perform any physical exercise programme and will continue with their daily tasks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 40-65 years
- Controlled high blood pressure
- Sedentary
Key exclusion criteria (2 listed)
- Pregnant women
- Hypertensive patients with serious diseases that prevent safe physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-component trainingThe 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. | Other | Multi-component training |
| Continuous Cardiovascular TrainingThe 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. | Other | Continuous Cardiovascular Training |
Primary outcome
Changes in Blood Pressure from baseline at week 12.
Time frame: Two times. Baseline and 12 weeks later
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
21 secondary outcomes
Changes in Mean Blood Pressure from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Pulse Pressure from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Dual Product from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Baseline Heart Rate from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in weight from baseline at 12 weeks.
Time frame: Two times. Baseline and 12 weeks later
Changes in Skeletal Muscle Mass from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Body Fat Mass from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Body Mass Index from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later].
Changes in Body Fat Percentage from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Visceral Fat from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Phase Angle from Baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Waist circumference from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Total Cholesterol from Baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in HDL from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in LDL from baseline at one week
Time frame: Two times. Baseline and 12 weeks later
Changes in Triglycerides from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Glucose from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Change in Manual Handgrip Strength from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Upper Body Strength from Baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Lower Body Strength from Baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Changes in Cardiorespiratory Capacity from baseline at week 12
Time frame: Two times. Baseline and 12 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component training and Continuous Cardiovascular Training in people with Hypertension, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Blood Pressure from baseline at week 12. (time frame: Two times. Baseline and 12 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.