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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Ambulatory blood pressure monitoring
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Pulse pressure(Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2))
- Muscle function(Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2))
- Systolic blood pressure(Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2))
- Mean blood pressure(Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2))
- Control of dietary intake(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.)
- Aerobic function(Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2))
- Diastolic blood pressure(Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2))
- Antihypertensive medication(Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2))
- Lipid lowering medication(Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2))
- Lipid profile(Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2))
- Balance(Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2))
- Framingham tables by category(Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2))
Investigators
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia