Clinical trial NCT04832048: Modifications in Cardiovascular Risk Factors When Performing Physical Exercise in Hypertensive and Dyslipidemic Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Blood Pressure monitoring
Primary care
Physical exercises
Training intensity
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, randomized, parallel-group, controlled, and open-label study was conducted.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ambulatory blood pressure monitoring
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
measure: Diastolic blood pressure
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
measure: Mean blood pressure
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
measure: Pulse pressure
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
measure: Lipid profile
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
measure: Antihypertensive medication
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
measure: Lipid lowering medication
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
measure: Control of dietary intake
timeFrame: 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.
measure: Muscle function
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
measure: Balance
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
measure: Aerobic function
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
measure: Framingham tables by category
timeFrame: Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: