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Completed

NCT Number: NCT04832048

Modifications in Cardiovascular Risk Factors When Performing Physical Exercise 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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

No Physical Exercise

Other

No programmed physical exercise

Primary outcomes

  1. 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

  1. Systolic blood pressure

    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

  2. Diastolic blood pressure

    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

  3. Mean blood pressure

    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

  4. Pulse pressure

    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

  5. Lipid profile

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

    Blood samples

  6. Antihypertensive medication

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

    Record of medication and dosage

  7. Lipid lowering medication

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

    Record of medication and dosage

  8. Control of dietary intake

    Time frame: 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.

    Diet source

  9. Muscle function

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

    Isokinetic dynamometry.

  10. Balance

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

    Force platform Kistler

  11. Aerobic function

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

    Modified Balke-Ware protocol on a rolling mat

  12. Framingham tables by category

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

    Physicians Global Assessment to measure cardiovascular risk

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study 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.

Acronym: ACTIVA

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Apr 5, 2021
Registry last updated
Apr 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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