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

NCT04832048 | Completed DMC

• 1 other identifier: UCAMCFE-00021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Systolic blood pressure

  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)

• Mean blood pressure

  Measurements will be taken at baseline and 12 weeks (phase 1) and at baseline and 16 weeks (phase 2)

• Pulse pressure

  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)

Study Arms (3)

High intensity training (HIT) group

EXPERIMENTAL

The HIT group performed the exercises with loads at 80-90% of HRF.

Other: Therapeutic physical exercise

Low-moderate intensity training (LMIT) group

EXPERIMENTAL

The HIT group performed the exercises with the loads at 50-70% of the HRF

Other: Therapeutic physical exercise

No training group

PLACEBO COMPARATOR

They did not perform any type of programmed physical exercise during the study.

Other: No physical exercise

Interventions

Therapeutic physical exercise OTHER

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).

High intensity training (HIT) group; Low-moderate intensity training (LMIT) group

No physical exercise OTHER

No programmed physical exercise

No training group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 40 and 65 years.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: September 20, 2016
• Primary Completion: June 12, 2017
• Study Completion: December 20, 2019
• Last Updated: April 5, 2021

Record last verified: 2016-09

Locations

ES (1)