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Completed

NCT Number: NCT01910935

Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.

The purpose of this study is to evaluate the effectiveness of a program to increase the physical activity of hypertensive patients using medical services and sports facilities of the Mexican Social Security Institute. The primary hypothesis to be proven is: The intervention will increase the proportion of hypertensive patients complying the physical activity minimum at week to get benefits on health in 20%, compare to patients in control group.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Mexicano del Seguro Social. Morelos. HGR/MF. No, UMF 3, UMF 20, UMF 23

Cuernavaca, Morelos, 62000, Mexico

About this study

Secondary Hypothesis:

The intervention achieved a significant change in the group of hypertensive patients in the following variables:

  • Decreased levels of systolic and diastolic blood pressure, biochemical markers such as total cholesterol, triglycerides and fasting blood glucose and increased HDL cholesterol.
  • Increase muscular endurance and cardio-respiratory capacity according to the categories of risk stratification.
  • Decreased body weight, body mass index and waist circumference.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosed with high blood pressure <5 years of evolution and / or without use of drug therapy to treat that condition;
  • with low levels of physical activity (PA) or physically inactive (less than 150 minutes of PA at week, intensity moderate to vigorous);
  • with availability to PA practice or considering begin to PA practice within the next six months (contemplation or preparation stages of the Transtheoretical Model).
  • Without cardiovascular risk (assessed previously);
  • Without physical or mobility problems that impede PA practice;
  • Willingness to participate in the study, fulfill with outlined activities to develop the proposal.

Exclusion criteria

  • high-risk patients according to the risk stratification of the American College of Sports Medicine;
  • fulfill the high recommendation of physical activity (more than 300 minutes per week of moderate to vigorous intensity);

Treatment and study plan

Physical activity prescription to develop program in group.

Behavioral

Overall the intervention involves a medical reference in primary care (PHC) to hypertensive patients (during routine consultation) to assist the sports facilities of the same Institute, to develop a group program of physical activity which will last 24 weeks. Led by the trained staff in physical activity to patients with chronic diseases.

Primary outcomes

  1. Physical activity. Level of physical activity between intervention and control groups.

    Time frame: 24 weeks

    The length of the intervention is 24 weeks, the control group will be followed for 24 weeks also. The outcome measure is a composite at three moments of the study. Basal measurement, 24 weeks and 36 weeks, this last moment to assess sustainability of the intervention.

    The intervention will be effective if the difference in the percent of population (complying the minimum recommended of physical activity) among control and intervention groups is at least of 20%.

Secondary outcomes

  1. Blood pressure

    Time frame: 24 weeks

    Blood pressure among intervention and control groups, at the three moments of the study: basal measurement, 24 weeks (end of the intervention) and 36 weeks. The outcome measure is a composite at three moments of the study. Basal measurement, 24 weeks and 36 weeks, this last moment to assess sustainability of the intervention.

Other outcomes

  1. Composite measure of biochemical markers: total cholesterol, triglycerides and fasting blood glucose

    Time frame: 24 weeks

    Biochemical markers (total cholesterol, triglycerides and fasting blood glucose) among intervention and control groups, at the three moments of the study: basal measurement, 24 weeks (end of the intervention) and 36 weeks. The secondary outcome measure is a composite at three moments of the study. Basal measurement, 24 weeks and 36 weeks, this last moment to assess sustainability of the intervention.

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2013
Registry last updated
Jun 6, 2014

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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