HypertensionACTIVANCT04832048
Modifications in Cardiovascular Risk Factors When Performing Physical Exercise in Hypertensive and Dyslipidemic Patients
A study testing Therapeutic physical exercise and No physical exercise in people with Hypertension, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Single-center, randomized, parallel-group, controlled, open-label study. The aim of the study was to evaluate the effects of an exercise training program intervention of different intensities (high intensity versus low-moderate intensity) on blood pressure reduction as a complementary strategy in hypertensive… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Therapeutic physical exercise and No physical exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2016to 20 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 65 years.
- Under treatment with at least one antihypertensive drug for hypertension. Treatment should have lasted at least 12 months prior to inclusion in the study.
- Diagnosed with dyslipidemia under pharmacological treatment or with a specific hypercholesterolemia (> 200 mg/dL) in the past and a cholesterol level at the start of the study greater than 200 mg/dL.
- Patient in Primary Prevention.
- Subjects who do not develop physical exercise scheduled on a weekly basis.
- Subjects who have given written informed consent to participate in the study.
Who cannot join
- Serious or terminal illnesses.
- Diagnosis of ischemic and/or cerebrovascular heart disease.
- Presence of chronic diseases that prevent the performance of a physical exercise program or a stress test (disabling arthropathies, chronic moderate/severe pneumopathies, arrhythmias, etc).
- Severe mental illnesses: psychosis, severe depressive disorder, neurosis.
- Diabetes mellitus.
- Presence of absolute or relative contraindications dictated by the American College of Sports Medicine (ACSM, 1995), during the performance of the stress tests.
- Pregnant or breast-feeding women
- Inability to understand the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Clinical Trial on the Modifications of Cardiovascular Risk Factors When Performing Different Therapeutic Physical Exercise Programs With Different Intensities in Hypertensive and Dyslipidemic Patients.
Single-center, randomized, parallel-group, controlled, open-label study. The aim of the study was to evaluate the effects of an exercise training program intervention of different intensities (high intensity versus low-moderate intensity) on blood pressure reduction as a complementary strategy in hypertensive individuals being treated with at least one antihypertensive drug.
Read the detailed description
All participants included in the study were referred by their primary care physicians, who prescribed physical exercise as a healthy lifestyle intervention added to the antihypertensive regimens in the framework of the "ACTIVA-Murcia Program".
Participants in the HIT and LMIT groups followed the same physical training program, with the only difference being the intensity of the training. The program included two phases of physical exercise lasting 12 weeks and 16 weeks, respectively, separated by a 7-week rest period, which coincided with a holiday period. The times of both phases were not equal in terms of duration, since it is a community physical exercise program established by the Region of Murcia, and does not depend on the researchers.
The program was developed by graduates in Physical Activity and Sport Sciences, who were in charge of teaching the exercises and supervised each training session.
Participants assigned to the HIT and LMIT groups were given guidelines to continue physical exercise during the 7-week rest period, while participants in the control group were offered to participate in the program after the study.
- Conditions
- Hypertension
- Being tested
- Therapeutic physical exercise, No physical exercise
- Keywords
- Blood Pressure monitoring, Primary care, Physical exercises, Training intensity
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic physical exerciseOther
The physical training program was carried out 3 days a week in 1-hour sessions focused on basic endurance exercises (global body activities), strength (specific muscle region activities) and flexibility.
Intensity was be determined by Maximum Heart Rate (HRF).
No physical exerciseOther
No programmed physical exercise
| Study group | Role | What they receive |
|---|---|---|
| High intensity training (HIT) group | Experimental | The HIT group performed the exercises with loads at 80-90% of HRF. Receives: Other: Therapeutic physical exercise |
| Low-moderate intensity training (LMIT) group | Experimental | The HIT group performed the exercises with the loads at 50-70% of the HRF Receives: Other: Therapeutic physical exercise |
| No training group | Placebo comparator | They did not perform any type of programmed physical exercise during the study. Receives: Other: No physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure monitoring
Blood pressure is measured with a holter
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary outcomes (12)
Systolic blood pressure
Blood pressure is measured with a holter
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Diastolic blood pressure
Blood pressure is measured with a holter
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Mean blood pressure
Blood pressure is measured with a holter
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Pulse pressure
Blood pressure is measured with a holter
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Lipid profile
Blood samples
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Antihypertensive medication
Record of medication and dosage
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Lipid lowering medication
Record of medication and dosage
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Control of dietary intake
Diet source
Measured: A nutritional registry will be carried out. The nutritional intake of three days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
Muscle function
Isokinetic dynamometry.
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Balance
Force platform Kistler
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Aerobic function
Modified Balke-Ware protocol on a rolling mat
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Framingham tables by category
Physicians Global Assessment to measure cardiovascular risk
Measured: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start20 Sep 2016
- Primary completion12 Jun 2017
- Study completion20 Dec 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, randomized, parallel-group, controlled, and open-label study was conducted.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832048
- Sponsor's protocol ID
- UCAMCFE-00021
- Acronym
- ACTIVA
- Status last verified
- Sep 2016
- First submitted
- 31 Mar 2021
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Trial on the Modifications of Cardiovascular Risk Factors When Performing Different Therapeutic Physical Exercise Programs With Different Intensities in Hypertensive and Dyslipidemic Patients.
- ClinicalTrials.gov ID
- NCT04832048
- Acronym / sponsor ID
- ACTIVA / UCAMCFE-00021
- Conditions
- Hypertension
- Keywords
- Blood Pressure monitoring, Primary care, Physical exercises, Training intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 5 Apr 2021 (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.
Single-center, randomized, parallel-group, controlled, open-label study. The aim of the study was to evaluate the effects of an exercise training program intervention of different intensities (high intensity versus low-moderate intensity) on blood pressure reduction as a complementary strategy in hypertensive individuals being treated with at least one antihypertensive drug.
Detailed description
All participants included in the study were referred by their primary care physicians, who prescribed physical exercise as a healthy lifestyle intervention added to the antihypertensive regimens in the framework of the "ACTIVA-Murcia Program".
Participants in the HIT and LMIT groups followed the same physical training program, with the only difference being the intensity of the training. The program included two phases of physical exercise lasting 12 weeks and 16 weeks, respectively, separated by a 7-week rest period, which coincided with a holiday period. The times of both phases were not equal in terms of duration, since it is a community physical exercise program established by the Region of Murcia, and does not depend on the researchers.
The program was developed by graduates in Physical Activity and Sport Sciences, who were in charge of teaching the exercises and supervised each training session.
Participants assigned to the HIT and LMIT groups were given guidelines to continue physical exercise during the 7-week rest period, while participants in the control group were offered to participate in the program after the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A single-center, randomized, parallel-group, controlled, and open-label study was conducted.
| Arm | Type | Receives |
|---|---|---|
| High intensity training (HIT) group | Experimental | Other: Therapeutic physical exerciseThe HIT group performed the exercises with loads at 80-90% of HRF. |
| Low-moderate intensity training (LMIT) group | Experimental | Other: Therapeutic physical exerciseThe HIT group performed the exercises with the loads at 50-70% of the HRF |
| No training group | Placebo comparator | Other: No physical exerciseThey did not perform any type of programmed physical exercise during the study. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 40 and 65 years.
- Under treatment with at least one antihypertensive drug for hypertension. Treatment should have lasted at least 12 months prior to inclusion in the study.
- Diagnosed with dyslipidemia under pharmacological treatment or with a specific hypercholesterolemia (> 200 mg/dL) in the past and a cholesterol level at the start of the study greater than 200 mg/dL.
- Patient in Primary Prevention.
- Subjects who do not develop physical exercise scheduled on a weekly basis.
Key exclusion criteria (8 listed)
- Serious or terminal illnesses.
- Diagnosis of ischemic and/or cerebrovascular heart disease.
- Presence of chronic diseases that prevent the performance of a physical exercise program or a stress test (disabling arthropathies, chronic moderate/severe pneumopathies, arrhythmias, etc).
- Severe mental illnesses: psychosis, severe depressive disorder, neurosis.
- Diabetes mellitus.
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 |
|---|---|---|
| Therapeutic physical exerciseThe physical training program was carried out 3 days a week in 1-hour sessions focused on basic endurance exercises (global body activities), strength (specific muscle region activities) and flexibility. Intensity was be determined by Maximum Heart Rate (HRF). | Other | High intensity training (HIT) group, Low-moderate intensity training (LMIT) group |
| No physical exerciseNo programmed physical exercise | Other | No training group |
Primary outcome
Ambulatory blood pressure monitoring
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Blood pressure is measured with a holter
12 secondary outcomes
Systolic blood pressure
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Diastolic blood pressure
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Mean blood pressure
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Pulse pressure
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Lipid profile
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Antihypertensive medication
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Lipid lowering medication
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Control of dietary intake
Time frame: A nutritional registry will be carried out. The nutritional intake of three days in two periods will be collected. One record at the beginning and another at the end, that is, six days.
Muscle function
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Balance
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Aerobic function
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Framingham tables by category
Time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
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 5 Apr 2021.
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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 Therapeutic physical exercise and No physical exercise 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 6 inclusion and 8 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 5 Apr 2021. 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. Some participants in this study may receive a placebo. 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?
Ambulatory blood pressure monitoring (time frame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)). 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 5 Apr 2021.