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

Hypertension Clinical Trial

— ACTIVA  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04832048
• Other study ID #: UCAMCFE-00021
• Status: Completed
• Phase: N/A
• Start date: September 20, 2016
• Est. completion date: December 20, 2019

Study information

• Verified date: September 2016
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 individuals being treated with at least one antihypertensive drug.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 20, 2019
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Therapeutic physical exercise
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 exercise
No programmed physical exercise

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory blood pressure monitoring	Blood pressure is measured with a holter	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary	Systolic blood pressure	Blood pressure is measured with a holter	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary	Diastolic blood pressure	Blood pressure is measured with a holter	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary	Mean blood pressure	Blood pressure is measured with a holter	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary	Pulse pressure	Blood pressure is measured with a holter	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary	Lipid profile	Blood samples	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary	Antihypertensive medication	Record of medication and dosage	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary	Lipid lowering medication	Record of medication and dosage	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary	Control of dietary intake	Diet source	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.
Secondary	Muscle function	Isokinetic dynamometry.	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary	Balance	Force platform Kistler	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary	Aerobic function	Modified Balke-Ware protocol on a rolling mat	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Secondary	Framingham tables by category	Physicians Global Assessment to measure cardiovascular risk	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)