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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Therapeutic physical exercise; Other: No physical exercise

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High intensity training (HIT) group; The HIT group performed the exercises with loads at 80-90% of HRF.	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).
Experimental: Low-moderate intensity training (LMIT) group; The HIT group performed the exercises with the loads at 50-70% of the HRF	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).
Placebo Comparator: No training group; They did not perform any type of programmed physical exercise during the study.	Other: No physical exercise; No programmed physical exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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)
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)
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)
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)
Lipid profile	Blood samples	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	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	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Muscle function	Isokinetic dynamometry.	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)
Balance	Force platform Kistler	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	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	Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2016
• Primary Completion (Actual): June 12, 2017
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Primary care; Physical exercises; Blood Pressure monitoring; Training intensity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: UCAMCFE-00021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No