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Modifications in Cardiovascular Risk Factors When Performing Physical Exercise in Hypertensive and Dyslipidemic Patients

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04832048
Acronym
ACTIVA
Enrollment
90
Registered
2021-04-05
Start date
2016-09-20
Completion date
2019-12-20
Last updated
2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Blood Pressure monitoring, Primary care, Physical exercises, Training intensity

Brief 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 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.

Interventions

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 programmed physical exercise

Sponsors

Universidad Católica San Antonio de Murcia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A single-center, randomized, parallel-group, controlled, and open-label study was conducted.

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Ambulatory blood pressure monitoringMeasurements 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

Secondary

MeasureTime frameDescription
Diastolic blood pressureMeasurements 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
Mean blood pressureMeasurements 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
Pulse pressureMeasurements 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
Lipid profileMeasurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)Blood samples
Antihypertensive medicationMeasurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)Record of medication and dosage
Systolic blood pressureMeasurements 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
Control of dietary intakeA 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.Diet source
Muscle functionMeasurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)Isokinetic dynamometry.
BalanceMeasurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)Force platform Kistler
Aerobic functionMeasurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)Modified Balke-Ware protocol on a rolling mat
Framingham tables by categoryMeasurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)Physicians Global Assessment to measure cardiovascular risk
Lipid lowering medicationMeasurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)Record of medication and dosage

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026